Nervous System Diseases

All Conditions

Symptoms and General Pathology

Heart and Blood Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Nutritional and Metabolic Diseases

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

Rare Diseases

Cerebral Palsy

Paralysis

Heart Diseases

Lung Diseases

Metabolic Diseases

Heart Defects, Congenital

Metabolism, Inborn Errors

Brain Injuries

Brain Damage, Chronic

Brain Diseases

Central Nervous System Diseases

Respiratory Tract Diseases

Congenital Abnormalities

Cardiovascular Abnormalities

Genetic Diseases, Inborn

Chronic Graft Versus Host Disease

Receipt of a novel mobile-health tool, GoalKeeper Plus Standard Care

Mobile-health communication tool for parents of children with medical complexity

GoalKeeper

Standard Care

Lee M Sanders, MD, MPH

This proposal addresses the major challenge of improving health outcomes for children with cancer and other complex conditions, for whom the effectiveness of outpatient care depends on care coordination across a diverse group of caregivers that includes parents, community support organizations and pediatric care providers. The investigators have developed GoalKeeper, a prototype system for supporting care coordination across multiple care providers. The primary aim of the clinical trial is to assess the potential for this new system, GoalKeeper, to improve meaningful use of goal-centered care plans in the care of children with cancer and other complex chronic conditions.

The overarching aim of the research is to improve care coordination and goal setting for children with medical complexity (CMC). Specific aims of the pilot clinical trail are as follows: (1) To assess the efficacy of GoalKeeper on goal-setting in the health care encounter. (2) To examine the roles of parent health literacy and parent activation in moderating the effect of the intervention.

Study Population: Stanford's Primary and Subspecialty Care Clinics at Stanford Children's Health will serve as the setting for study recruitment.

The pilot randomized controlled trial will enroll 60 parents of children with medical complexity and their health-care providers. Eligibility criteria for participants will be age 18 years or older, English-speaking, and (for parents) child\<12 years old. Exclusion criteria are parent with known mental illness or neurocognitive impairment. A stepped wedge approach by provider will introduce families to GoalKeeper at different time points in the study. A pre-intervention period will occur at least 1 month before the trial start where clinical observations and baseline survey information will be obtained of each providers' practice.

Each family will be given training and 4-month access to the GoalKeeper application and participate in an exit interview at the end of study.

GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity

Intelligent Information Sharing: Advancing Teamwork in Complex Care

Parent perception will be measured using the "National Survey of Children with Special Health Care Needs Shared Decision Making Domain," which includes 4 domain items each with a scale of 1 (never), 2 (sometimes), 3 (usually) or 4 (always). Positive SDM is defined as parent report of "usually" or "always" on all 4 items. Shared decision making refers to a communication process where parents and providers participate in decision making to reach treatment plan agreement.

Parent perception of goal-centered care will be measured using a modified version of the "Patient Assessment of Chronic Illness Care, Goal-Setting Domain" questionnaire, using a scale of 1(Almost Never) to 5 (Almost Always) with higher values representing better goal-centered care.

Change in perception in quality of goal-centered care will be assessed by Investigators based on parent baseline interviews and parent exit interviews.

National Cancer Institute (NCI)

Harvard University

Stanford University

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Musculoskeletal Diseases

Kidney Diseases

Hypertension

Diabetes Mellitus

Stroke

Arthritis

Frailty

Heart Failure

Chronic Disease

Osteoporosis

Bone Diseases

Bone Diseases, Metabolic

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Disease Attributes

At regular intervals (the "steps") one cluster (i.e., one site) is randomised to cross from the control to the intervention under evaluation. This process continues until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed. Four sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart.

Each cluster contributes observations under both control and intervention observation periods.

Exercise:A kinesiologist-led twice-weekly program. Prior to attending the program, each attendee gets a 1:1 session with the kinesiologist to decide exercise starting levels. Group exercises start with a warm-up stepping game. Participants then perform 2 sets of 8 repetitions of each exercise, gradually progressing to an intensity of 3-8 repetitions maximum. Exercises include one each of a push, pull, squat, reach/press, lunge/step-up, lift and carry movement. After, there is a 10-minute group discussion to prompt making exercise routine at home. Nutrition:Two dietitian-led interactive group seminars to promote strategies to increase protein intake and sampling of protein-rich snacks and protein supplements. Seminar topics consider the cost to prepare high protein foods, the ability of retirement home residents to alter diet, how and why to spread protein intake through the day, how much protein is in their usual choices, and easy-to-consume protein-rich snacks.

Strength and Balance Training & Nutrition Education

During periods when a site is not involved in the MoveSTroNg program, participants will continue with their usual care routine. Usual care routines should not involve strength and balance exercises.

Usual Care

There is strong evidence that specific types of exercise can improve health and physical function in older adults. While community exercise classes exist, many older adults with chronic conditions may need guidance from credentialed exercise professionals to ensure sufficient dose and progression and to address fears or low exercise self-efficacy. Furthermore, low protein intake among older adults is common and initiating exercise when nutrition is inadequate may cause weight loss and limit gains in muscle strength. The primary goal is to determine the feasibility of implementing the MoveSTroNg program under real-world conditions, measured through referral and recruitment to the program and study retention and adherence rates.

The MoveStrong trial is a 1-year pilot closed cohort stepped wedge randomized control trial (RCT) to evaluate the feasibility of implementation of the MoveStrong program. This program includes a functional exercise and nutrition program that teaches older adults with chronic diseases how to perform functional resistance and balance exercises and promote adequate protein intake and nutrition. Four sites (1 Northern and 3 Southern Ontario sites) will be cluster-randomized to implement MoveStrong at one of four start times, each three weeks apart. The primary outcome will be to determine the feasibility of recruitment and referral from diverse settings (i.e., retirement homes, community centers, and family health teams) and establish the retention and adherence to the program. Secondary objectives will determine the following: What are the participant's and provider's experience with the MoveStrong program? What is the short-term responsiveness (i.e., ability to detect change) of frailty indicators (Fried Frailty Index components), protein intake, or quality of life? Who agrees to participate? What adaptations need to be made to MoveStrong, or study methods in each setting? What is the cost relative to the benefit? Is behaviour change maintained in the maintenance period? Our long term goal is to use the information from this project to develop, implement, and evaluate a sustainable, scalable and pragmatic model to deliver strength and balance training and promote adequate protein intake among older adults with chronic diseases.

We will use a closed cohort stepped wedge design at 4 sites (1 in Northern Ontario and 3 in Southern Ontario). In a stepped wedge, sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart.

Functional Exercise and Nutrition Education Program for Older Adults

A Model for Delivering Strength Training and Nutrition Education for Older Adults (MoveStrong): A Pilot Randomized Controlled Trial

If requested we will consider sharing data. If raw data is shared, participant data will be deidentified.

Definition: Number recruited at end of rollout. The criterion for success is to recruit 10 participants at each of 4 sites.

Definition: Number retrained at post-rollout end. The criterion for success is 90% at rollout end.

Definition: Percentage of individuals that attended exercise and nutrition sessions.

The criterion for success is 70% or higher.

Fried Frailty Index Components: We will measure the change in body weight with a calibrated scale. A change of 5% (greater or lower) in 1 year is considered worse.

Fried Frailty Index Components: walking speed via the 10-meter walk test protocol. A change of 0.05 m/s is considered as a small meaningful change, while 0.13m/s is considered a substantial change.

Fried Frailty Index Components: fatigue/exhaustion via the Center for Epidemiologic Study Depression Scale-Fatigue Questions. The score ranges from 0-60 (higher scores reflect increased symptom severity)

Fried Frailty Index Components: lower physical activity via the CHAMPS Physical Activity Questionnaire for older adults. No score, but the recommended physical activity levels are 150 minutes of moderate to vigorous activity and 2 days of strength training of major muscle groups.

Fried Frailty Index Components: weakness via the Jamar hand-held dynamometer

We will use a chair with a straight back without arm rests (seat 17" high), and a stopwatch. This will assess leg strength and endurance. Scores range depending on age and sex (e.g., male 60 to 64, \< 14 chair stands is considered below average, while a male 65 to 69, \< 12 is below average).

The Four Square Step Test is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward. For older adults \> 15 seconds indicates increased risk of falls

The EuroQol 5 dimension version 5-level (EQ-5D-5L) measures quality of life using 5 dimensions, on a 5 point scale, where a higher point is considered better.

The EuroQol 5 dimension version 5-level (EQ-5D-5L) also records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). This information can be used as a quantitative measure of health as judged by the individual respondents. A higher score indicates better quality of life

We will use the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool to conduct interviewer administered diet recalls for 2 weekdays and 1 weekend day. Nutrient analysis is automated and will be used to quantify and compare protein and energy intakes at baseline and follow-up only. There is no scale to this section

We will use a semi-structured interview guide to conduct exit interviews with each participant and kinesiologist. Interviews and training sessions will be audio-recorded and transcribed verbatim. Two researchers will perform thematic analyses to describe participant and provider experience and satisfaction, adaptations, and learning needs. There is no scale to this section

We will ask participants to report adverse events and falls, using Health Canada definitions. We will report serious and non-serious adverse events (total and attributable to intervention). There is no scale to this section

We will use the Productivity and Activity Index questionnaire to assess indirect resource use over the last 6 weeks of the program.There is no scale to this section

We will use the Health Utility Form to assess direct medical resource use over the last 6 weeks of the program. Direct medical costs will be measured using a closed and open-ended survey about their personnel, hospitalization, medications, rehabilitation, and test costs. This questionnaire also evaluates out of pocket expenses and transportation.There is no scale to this section

Canadian Institutes of Health Research (CIHR)

City of Lakes family Health Team

Schlegel Villages and Research Institute for Aging

YMCA

Kinnect to Wellness

University of Waterloo

Obesity

This was the only arm in the study. All participants were allocated to this arm, where they received an 8-week remotely-delivered exercise and nutrition program.

Participants received two 1-on-1 exercise sessions per week to start. Each session lasted 30 minutes. As progress was made, participants were encouraged to exercise independently outside the structured sessions while continuing to receive a 1-on-1 session each week. The individualized exercises were aligned with functional movements to promote personal relevance: balance, pull, squat, push, hinge, lift \& carry and calf raise.

Exercise program

Participants received a nutrition education booklet and had access to five online videos that correspond to key topics in the booklet (reading nutrition labels, types of protein, foods containing protein, incorporating protein into meals, spreading protein in meals throughout the day). Participants attended three 60-minute nutrition Q\&A sessions led by a dietitian, where the group reviewed content from the booklet and videos, and discussed personalized strategies to increase protein intake.

Nutrition education

Lora Giangregorio, PhD

Sufficient muscle strength helps to get out of a chair and can prevent falls. Up to 30% of older adults experience age-related loss of muscle strength, which can lead to frailty and health instability. Exercise helps to build muscle, maintain bone density and prevent chronic disease, especially during the aging process. However, more than 75% of Canadian adults ≥18 years of age are not meeting physical activity guidelines. In addition, it is known that malnutrition, including low protein intake, may lead to poor physical function. While there are services to support exercise and nutrition, barriers to implementing them persist. The COVID-19 pandemic has exacerbated the potential for physical inactivity, malnutrition, and loneliness among older adults, especially those with pre-existing health or mobility impairments. Now and in future, alternate ways to promote exercise and proper nutrition to the most vulnerable are needed. The investigators propose to adapt MoveStrong, an 8-week education program combining functional and balance training with strategies to increase protein intake. The program was co-developed with patient advocates, Osteoporosis Canada, the YMCA, Community Support Connections and others. MoveStrong was delivered by telephone or web conference to older adults in their homes, using mailed program instructions, 1-on-1 training sessions through Physitrack®, as well as online nutrition Q\&A sessions and group discussion sessions over Microsoft® Teams. The primary aim of this study was to assess feasibility and acceptability of a remote model as determined by recruitment (≥ 25 people in 3 months), retention (≥80%), adherence of (70%) and participant experience.

MoveStrong at Home is an 8-week pilot study with a 4-week follow-up.

The primary research question pertains to the feasibility of implementation, defined by recruitment (number of participants recruited), retention (number retained at follow up), and adherence (percentage of exercise and nutrition sessions completed) and participant experience. The criteria for success included recruitment of 8 participants per month (up to a total of 25 participants in 3 months), retention of ≥80% at follow-up, and adherence of ≥70% across all exercise and nutrition sessions.

For secondary outcomes, the investigators assessed the effects of MoveStrong at Home on physical activity, fatigue, mental health and social isolation, quality of life, as well as protein/energy intake via telephone at baseline, post intervention and at follow-up. The following questionnaires were used: Physical Activity Scale for the Elderly; Centre for Epidemiologic Studies Depression Scale-fatigue questions; Warwick-Edinburgh Mental Well-being Scale; EQ5D5L20; and the Automated Self-Administered 24-Hour Dietary Assessment Tool (via interview). Physical function was assessed at baseline, post intervention and at follow-up using adapted and self-administered versions of the Short Performance Physical Battery balance test and the 30-second chair stand test. Qualitative exit and follow-up interviews were used to capture participant experience and identify barriers and facilitators to implementation and maintenance. The investigators monitored falls and adverse events throughout the study.

The investigators recruited participants in two phases. The investigators recruited 9 participants between October 5th and October 23rd, 2020 to begin the intervention together by November 2020. Participants recruited after that date participated in screening and assessments between November 2020 and January 2021, and began the intervention in January 2021. The investigators considered making modifications to the protocol to address any challenges that arose during delivery with the first phase of participants. Investigators over recruited by 5 participants to account for possible dropouts.

Each participant started the intervention with two 1-on-1 sessions on non-consecutive days (Monday to Friday) and completed the third session on their own. As progress is made, participants continued to receive a 1-on-1 session each week and completed two sessions independently. If a participant was unable to attend a 1-on-1 session due to a prior commitment, illness, or injury, a make-up session was scheduled for the same week or following week as necessary.

In addition, individuals participated in three dietitian-led virtual group Q\&A sessions to review content from the booklet and videos, as well as discuss more personalized strategies to increase protein intake. The dietitian considered the cost of preparing high-protein foods and the accessibility of these foods during a time of physical distancing. 60-minute small group seminars (5-10 participants) occurred on weeks 2, 4, and 6 (Wednesday).

An optional group discussion session that focused on behaviour change techniques took place on weeks 3, 5 \& 7 (Wednesday). The intention was to foster a sense of community and allow participants to share their experiences with one another. These sessions did not count toward adherence.

The goal of the investigators was not to test the efficacy of exercise, but to evaluate the implementation of a scalable and sustainable models to promote exercise at home or in the community.

This is an 8-week feasibility study with a 4-week follow-up. Time series design.

Note: 6-month follow-up was optional and exploratory in nature.

MoveStrong at Home: A Feasibility Study of a Model for Remote Delivery of Functional Strength and Balance Training Combined With Nutrition Education for Older Pre-frail Adults.

The number of participants recruited \>25.

Feasibility threshold: The number of participants retained at follow-up \>80%.

Participants were encouraged to attend 3 nutrition sessions that took place on weeks 2, 4 and 6 of the intervention (12 weeks).

Feasibility threshold: "Attendance" or the average proportion of nutrition sessions \>67% or \>2/3 sessions.

Participants were encouraged to complete at least 3 exercise sessions per week (one supervised and two independent) for the duration of the intervention (12 weeks).

Feasibility threshold: "Attendance" or the average proportion of exercise sessions completed \>70% or 25.3/36 sessions.

A Physical Activity Screen (PAS) was used to capture average minutes of moderate-to-vigorous physical activity each week (Clark et al., 2020). This tool was created based on questions used by Exercise is Medicine in the Physical Activity Vital Sign questionnaire (Greenwood et al., 2010). The results were compared to national exercise guidelines for older adults that promote ≥150 minutes and ≥2 session of muscle strengthening per week. A higher score indicated a better outcome.

A modified version of the Exercise Self-Efficacy Scale (ESES) was used to assess levels of planning and execution of exercise related activities (Resnick \& Jenkins, 2000). There were a total of 11 questions. The lowest response option to each question was "Not true at all = 1", while the highest was "Exactly true = 5". Responses closer to the highest response option indicate a better outcome. Overall instrument score ranged from 11-55 points.

The 30-second Chair Stand was used to access lower extremity muscle function (Bohannon, 1995; Jones et al., 1999). The instructions for this test were adapted for self-administration under the remote supervisor supervision of the exercise physiologist. A higher score on the test indicated a better outcome.

Static balance was measured using Short Performance Physical Battery (SPPB) (J. M. Guralnik et al., 1994) balance subscale. The subscale scores ranged from 0-4, with a higher score indicating greater balance. The instructions for this test were adapted for self-administration under the remote supervisor supervision of the exercise physiologist.

Please note that the SPPB gait speed and chair stand subscales were not included as a part of the assessment. Therefore the total score for the SPPB (0-12) was not summed.

Fatigue was assessed using the Center for Epidemiologic Studies Depression Scale-fatigue questions (CES-D) (Radloff, 1977). Only two questions on the CES-D were used: "I felt that everything I did was an effort" and "I could not get going". Scores ranged from of 0-6 and were summed from the two selected questions (lowest response option was "Rarely (\<1 day) = 0", highest response option was "Nearly every day = 3"). Responses closer to the lowest response option indicated a better outcome.

The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) was used to assess positive aspects of mental health. Score ranges from 14-70 and were summed from 14 questions (lowest response option was "None of the time =1", highest response option was "All of the time = 5"). Responses closer to the highest response option indicated a better outcome.

The EuroQol Group 5 Dimension 5 Level (EQ5D5L) questionnaire was used to evaluate health-related quality of life (Herdman et al., 2011). The system comprised five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had five levels: "no problems = 1" to "extreme problems = 5". Responses with lower scores indicated a better outcome. An index value ranging from 0-1 is then generated from the equation by from the scores of the five domains (Xie et al. 2016)

The SCREEN tool is a valid and reliable nutrition questionnaire designed specifically for older adults (Keller et al., 2005). This tool was used to assess appetite, understand eating habits, and record recent changes in weight. Scores ranged from of 0-64 and were summed from 14 questions (lowest response option was "0", highest response option was "4"). Responses closer to the highest response option indicated a better outcome.

ASA24®-Canada was a guided web-based tool used to record a three 24-hour diet recalls. All food and drinks consumed by the participant on two weekdays and one weekend day (3 days in total) were reported to track protein intake (Subar et al., 2012). An average of the three days was then calculated.

Health Canada Definition

Public Health Agency of Canada (2018) Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry, Ministry of Health. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/reporting-adverse-reactions-marketed-health-products-guidance-industry.html

This was the only arm in the study. All participants were allocated to this arm, where they received an 8-week remotely-delivered exercise and nutrition program.

Exercise program: Participants received two 1-on-1 exercise sessions per week to start. Each session lasted 30 minutes. As progress was made, participants were encouraged to exercise independently outside the structured sessions while continuing to receive a 1-on-1 session each week. The individualized exercises were aligned with functional movements to promote personal relevance: balance, pull, squat, push, hinge, lift \& carry and calf raise.

Nutrition education: Participants received a nutrition education booklet and had access to five online videos that correspond to key topics in the booklet (reading nutrition labels, types of protein, foods containing protein, incorporating protein into meals, spreading protein in meals throughout the day). Participants attended three 60-minute nutrition Q\&A sessions led by a dietitian, where the group reviewed content from the booklet and videos, and discussed personalized strategies to increase protein intake.

Single Arm

Age, Continuous

Female

Male

Sex/Gender, Customized

Caucasian

South Asian

Race/Ethnicity, Customized

Canada

Recruitment was restricted to Ontario, Canada residents.

Region of Enrollment

Ellen Wang

Recruitment

2 participants withdrew from the intervention.

Retention

Average Adherence to Nutrition Sessions

Average Adherence to Exercise Sessions

Baseline

End of the study

Follow-up

Physical Activity

Exercise Self-efficacy Scale

End of study

30-second Chair Stand

Static Balance

Fatigue

Mental Health and Social Isolation

Quality of Life Score

Nutritional Risk

Dietary Protein Intake

Overall Study

Neoplasms

Immune System Diseases

Lung Neoplasms

Asthma

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Dyspnea

Lung Diseases, Interstitial

Bronchiectasis

Respiration Disorders

Signs and Symptoms, Respiratory

Bronchial Diseases

SELF-BREATHE + usual NHS care (Intervention)

Participants randomised to the control group continue with usual NHS care, as was available to them prior to entry into the trial

SELF-BREATHE is on online supportive self - management intervention for individuals living with chronic breathlessness due to respiratory disease. SELF-BREATHE provides user with educational resources about breathlessness and self - management techniques such as breathing exercises, goal setting which aims to help with their breathlessness.

SELF-BREATHE

Charles C Reilly, PhD,MSc,BSc

Charles C Reilly

Background:

Some health conditions make breathing difficult and uncomfortable. When this happens every day, it is called chronic breathlessness. Over 3 million people living with heart and lung disease have chronic breathlessness in the UK.

Breathlessness is very difficult for patients themselves and their families, resulting in disability and feelings of fear, distress, and isolation. Due a to lack of supportive breathlessness services many patients frequently attend hospital Accident and Emergency (A\&E) departments seeking help.

Given the on-going challenges faced by the National Health Service (NHS) in the United Kingdom, such as long waiting times, staff shortages, increased demand for services because of the COVID-19 pandemic, there is an urgent need to develop new ways to support those living with chronic breathlessness. One potential solution is to offer support online, as it is estimated that in the UK, 7 out of every 10 people with chronic breathlessness are internet users.

With the help of patients and NIHR funding the research team lead by Dr Charles Reilly, developed an online breathlessness supportive website called SELF-BREATHE. SELF-BREATHE provides information and self-management tools such as breathing exercises, that patients can do at home themselves.

SELF-BREATHE has been tested as part of its development. SELF-BREATHE is acceptable and valued by patients. But what is unknown is whether SELF-BREATHE improves patients' breathlessness and their life? This is the question this research seeks to answer.

Aims

1. To test if using SELF-BREATHE for six-weeks improves patients' breathlessness, their quality of life and whether SELF-BREATHE should be offered within the NHS
2. To see if patients opt to continue to use SELF-BREATHE after six-weeks and what benefits this may have for patients.

Methods

The research team are undertaking a randomised controlled trial. For this, 246 people living with chronic breathlessness will be recruited in to this study. Each person will be randomly chosen by a computer to continue with their usual care or their usual care plus access to SELF-BREATHE. All study participants will complete questionnaires at the start of the study, thereafter at seven and twelve weeks after randomisation.

These questionnaires will ask patients about 1) their breathlessness and its effect on their life and 2) planned and unplanned hospital visits. At the end of the study, we will compare answers to these questionnaires between the two groups at seven and 12 weeks.

This will tell if SELF-BREATHE improved patients' breathlessness and reduced their need for unplanned hospital visits e.g., A\&E attendances due to breathlessness.

Reducing Chronic Breathlessness in Adults by Following a Self-guided, Internet Based Supportive Intervention (SELF-BREATHE)

A Multicentre, Randomised Controlled Trial Comparing Usual NHS Care to a Self-guided Internet-based Intervention (SELF-BREATHE) Plus Usual NHS Care to Reduce Breathlessness in Adults Living With Chronic Breathlessness

The primary outcome is patient rated intensity of worst breathlessness over the previous 24 hours, using a validated 11-point (0-10) numerical rating scale (NRS), where 0 = no breathlessness, and 10 = worst imaginable breathlessness (Patient self-reported out-come measure)

King's College Hospital NHS Trust

Behaviors and Mental Disorders

Vascular Diseases

Mental Disorders

Problem Behavior

Psychotic Disorders

Behavioral Symptoms

Pharmaceutical Solutions

All Drugs and Chemicals

Participants in this arm are followed up using a telehealth solution, as specified by the National Directorate of Health at the local centre. The actual follow-up is personalized to the individual user. All users receive a tablet, which can be used to answer questions about own health and/or transmit clinical measurements.

Participants in this arm receive standard clinical care in accordance with their medinal needs.

Participants in this arm are followed up using a telehealth solution, as specified by the National Directorate of Health at the local centre. The actual follow-up is personalized to the individual user. All users receive a tablet, which can be used to answer questions about own health and/or transmit clinical measurements. This arm is not randomized, but otherwise identical to the randomized experimental arm.

Users of telemedicine can answer simple questions about their health condition and/or perform measurements related to their health (e.g., blood pressure, blood sugar, oxygen saturation, weight) via a tablet or a similar device. The results are transferred from the measuring devices to the tablet so that users can easily see them and track their own results over time. The results are transmitted digitally to a follow-up service. The follow-up service contacts the patient in case of signs of deterioration or when measurements lie outside what is normal values for the individual. The follow-up service provides medical support and guidance based on the patient's needs and plan for follow-up, and will, in consultation with the patient, assess whether this should contact their GP/emergency room.

Telemedicine: tablet and possibly tools to perform measurements

Tor Iversen, Professor

The Norwegian health authorities has initiated a three-year trial of telehealth solutions as part of the treatment of patients with chronic illness in the period 2018-2021. Within the trial, telehealth indicates that patients are followed-up outside health-care facilities using information and communication technologies (ICTs). Patients who are followed up using telehealth solutions can answer questions about their own health and/or perform measurements related to their health (e.g. blood pressure, blood glucose, oxygen measurement, weight) via a tablet according to a personalized schedule. The measurement values are transferred from the measuring devices to a tablet so that the users can easily see them and track their results over time. The results are also transmitted digitally to a follow-up service, a healthcare center with nurses, who contacts the patient when needed. The follow-up service provides medical support and guidance based on the patient's needs and planned follow-up, and will, in consultation with the user, evaluate whether the user should contact the general practitioner (GP) or emergency room.

The study population of the trial includes users with comprehensive medical needs, with medium to high risk of worsening of their condition, hospitalization or increased need for health and care services.

The evaluation includes three main parts: 1) An effect evaluation which is designed as a randomized control trial, 2) a cost-benefit analysis, and 3) a process evaluation which aims to provide recommendations for how to organize and implement telemedicine in clinical practice. The primary outcomes include physical and mental health state, patient experience and use of health services.

The effect evaluation is designed as a pragmatic open label multi-center randomized control trial, with two parallel arms with 300 patients in each arm. Patients are recruited between February 2019 and June 2020.

Pragmatic Randomized Control Trial of Telehealth vs Standard Care in Follow-up of Patients With Chronic Conditions

A Pragmatic Randomized Control Trial Comparing Telehealth With Standard Clinical Care in the Follow-up of Patients With Chronic Conditions Within the Primary Care Setting

Researchers are not allowed to share individual patient data with other researchers.

Patient's assessment of her health-related quality of life using the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire. The scale goes from 0 to 1 where higher scores mean a better outcome.

Patient's assessment of her health-related quality of life using Visual Analogue Scale (VAS). The scale goes from 0 to 100 where higher scores mean a better outcome.

Patients are asked to assess their overall satisfaction with their health care services: "To what extent are you satisfied with the follow-up of your health?". Answers on a four point scale ranging from "Not satisfied at all" to "Very satisfied"

The total cost of health and care services per patient is calculated by combining information on the use of health and care services with information about private and public costs of health and care services. Yearly health and care cost per person at baseline is defined as the yearly cost 365 days before inclusion. Similarly, the health and care cost at 12 months in defined as the total cost in the first year after inclusion. The change in mean is the primary outcome measure. Other changes, such as distributional changes, may be of interest.

Participants are asked the following question: "If you think about the last 7 days, to what degree have you experienced the following a) had problems sleeping at night b) had problems sleeping too much?" Answers on a four point scale ranging from "Not at all" to "To a very large extent".

Participants are asked the following question: "To what extent do you feel that you have control over your health situation?" Answers on a four point scale ranging from "Not at all" to "To a very large extent".

Patients answer the question "To what extent do you experience your GP is sufficiently involved in the follow-up of your health?" Answers are reported on a four point scale: "Not at all" to "To a very large extent".

Patients are asked "To what extent do you experience that you have opportunity to contribute to your own treatment?" Answers are reported on a four point scale: "Not at all" to "To a very large extent".

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity	NCT03620071	Childhood Cance... Cerebral Palsy Chronic Lung Di... Congenital Hear... Congenital Meta... Gastrostomy	GoalKeeper Standard Care	18 Years -	Stanford University
Functional Exercise and Nutrition Education Program for Older Adults	NCT04037436	Chronic Disease Frail Diabetes Mellit... Cancer Chronic Lung Di... Cardiovascular ... Congestive Hear... Hypertension Osteoporosis, O... Arthritis Stroke Kidney Diseases	Strength and Ba... Usual Care	60 Years -	University of Waterloo
MoveStrong at Home: A Feasibility Study of a Model for Remote Delivery of Functional Strength and Balance Training Combined With Nutrition Education for Older Pre-frail Adults.	NCT04663685	Arthritis Cancer Cardiovascular ... Chronic Lung Di... Congestive Hear... Diabetes Hypertension Kidney Diseases Obesity Osteoporosis Stroke Frailty	Exercise progra... Nutrition educa...	60 Years -	University of Waterloo
Reducing Chronic Breathlessness in Adults by Following a Self-guided, Internet Based Supportive Intervention (SELF-BREATHE)	NCT06326957	Chronic Obstruc... Bronchiectasis Interstitial Lu... Lung Cancer Asthma Dyspnea Fibrotic Lung D... Chronic Lung Di...	SELF-BREATHE	18 Years - 110 Years	King's College Hospital NHS Trust
Pragmatic Randomized Control Trial of Telehealth vs Standard Care in Follow-up of Patients With Chronic Conditions	NCT04142710	Chronic Disease Diabetes Vascular Diseas... Chronic Lung Di... Cancer Psychiatric Dis...	Telemedicine: t...	18 Years -	University of Oslo
GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity	NCT03620071	Childhood Cance... Cerebral Palsy Chronic Lung Di... Congenital Hear... Congenital Meta... Gastrostomy	GoalKeeper Standard Care	18 Years -	Stanford University
Functional Exercise and Nutrition Education Program for Older Adults	NCT04037436	Chronic Disease Frail Diabetes Mellit... Cancer Chronic Lung Di... Cardiovascular ... Congestive Hear... Hypertension Osteoporosis, O... Arthritis Stroke Kidney Diseases	Strength and Ba... Usual Care	60 Years -	University of Waterloo

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