Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Kidney Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Kidney Failure, Chronic

Hypersensitivity

Renal Insufficiency

Neoplastic Processes

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Renal Insufficiency, Chronic

Chronic Disease

Disease Attributes

Parathyroid Diseases

Endocrine System Diseases

Chronic Graft Versus Host Disease

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Vitamins

Vitamin D

Cholecalciferol

Vitamin D3

Calciferol

Mahmut Gucuk, MD

The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of selective Vitamin D Receptor Activator's as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Turkey. The relation of the safety data to PTH (Parathyroid hormone) suppression over time will be evaluated. Also the number and incidence of hypercalcemia and hyperphosphatemia will be recorded.

The scientific purpose of this study is to obtain data on the use of sVDRA(Selective Vitamin D Receptor Activator) in real-life clinical practice. This study will allow us to observe drug effectiveness in a distinct geography. Treatment effects, as well as maintenance of the results will be recorded for a 18 months period in order to obtain experience in the long term use of sVDRA(Selective Vitamin D Receptor Activator). Furthermore in the centers, additional blood parameter, hsCRP (high sensitivity C-reactive protein), will be examined as part of the clinical routine.

The primary aim of the study is:

* To assess percentage change in iPTH (intact parathyroid hormone) level monthly among hemodialysis patients with sHPT (secondary hyperparathyroidism) receiving sVDRA (Selective Vitamin D Receptor Activator) therapy.

Secondary aims are:

* To observe changes in commonly assessed biochemical parameters for bone and mineral metabolism (Ca (Calcium), P (Phosphorus), ALP (Alkaline phosphatase) and additionally hsCRP (high sensitivity C-reactive protein) as cardiovascular inflammatory marker.
* To evaluate routinely checked parameters like albumin, hemoglobin and dialysis adequacy (KT/V).
* To collect and evaluate data from all adverse events in order to establish the safety profile of sVDRA(Selective Vitamin D Receptor Activator) in daily clinical practice.
* To collect mortality data 6 months after 12 months of observational period or 6 months after drop out.

Patients will be followed for 12 months within the post-marketing observational study and will be checked for mortality data 6 months after this follow up period. The enrollment period should not exceed 6 months.

All demographic information will be summarized by using descriptive statistics and graphs. Laboratory levels will be assessed by using mean, median, minimum, maximum, standard deviation and percentages on visit basis. The mean differences on laboratory levels between visits will also be summarized by graphics and assessed by using percentages.

Alkaline phosphatase and hsCRP (high sensitivity C-reactive protein) levels will also be summarized by using descriptive statistics and graphs per visit.

sVDRA (Selective Vitamin D Receptor Activator) dose changes per visits will be summarized by descriptive statistics and graphs.

Mortality will be analyzed with life tables. By taking into account the primary and secondary aims of the study, to be able to achieve the therapeutic success on iPTH (intact parathyroid hormone) level changes with sVDRA (Selective Vitamin D Receptor Activator) treatment and perform mortality assessment in following 6 months and collect data regarding safety and efficacy of sVDRAs (Selective Vitamin D Receptor Activators) in long term use, it has been determined to enroll totally 510 patients from 30 sites.

A Study to Follow-up Patients With End Stage Renal Disease Undergoing Hemodialysis, Receiving Selective Vitamin D Receptor Activator's for Prevention and Treatment of Secondary Hyperparathyroidism

A 18 Months, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Hemodialysis, Receiving sVDRA's for Prevention and Treatment of Secondary Hyperparathyroidism

AbbVie (prior sponsor, Abbott)

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Behaviors and Mental Disorders

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Heart Failure

Death

Heart Diseases

Respiratory Tract Diseases

Quality of Life

Subjects in the first group ("Life Completion") completed a psychosocial intervention which consisted of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy.

The subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.

Subjects in the third group ("treatment as usual") were exposed to no intervention or attention control during the intervention window.

Subjects discussed life review, issues of forgiveness and heritage and legacy.

Life Completion

Subjects listened to a non-guided relaxation CD

Attention Control

Karen E. Steinhauser, PhD

The purpose of this study is to determine whether discussions of life story, forgiveness, and future goals improve quality of life for patients with serious illness.

This is a randomized control trial to evaluate the feasibility of the Outlook intervention. 221 veterans with advanced cancer, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) or end stage renal disease (ESRD) were randomly assigned to one of three intervention groups and completed a brief battery of pre-test measures. Subjects in the first group ("Outlook Intervention") were randomized to meet with a facilitator three times for a period of 45 min-1 hour. Participants were asked in the first session to discuss issues related to life review. They were asked in the second session to speak in more depth about issues of regret, forgiveness and things left undone. The subject of the final session was heritage and legacy. Participants in the attention control group were randomized to meet with a facilitator three times for a period of 45 min- 1 hour and listen to a non-guided relaxation audio disc (CD). Participants in the third group ("treatment as usual") were exposed to no interventional sessions. Participants were assessed with post-test measures administered by a blinded interviewer one week and 3 weeks after the intervention window.

Outlook Quality of Life Intervention Study

Outlook: An Intervention to Improve Quality of Life in Serious Illness Study

Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 4-item preparation sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 5 and maximum was 20 with higher numbers indicating higher preparation.

Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 7-item life completion sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 7 and maximum was 35 with higher scores indicating greater completion.

The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 0-20. Higher scores indicate greater anxiety.

Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.

The Functional Assessment of Chronic Illness Therapy- Spiritual Well-being Scale (Facit-SP) is a 12-item measure of faith, meaning and purpose, with a range of 0 to 48. Higher scores indicate greater spiritual well-being.

Functional assessment of Cancer Therapy-General) is a 27 item survey which assesses physical, social/family, emotional, and functional well being. This sub-scale assesses social well-being. We omitted an item assessing satisfaction with sex life, due to high missing data. Items are rated on a 5 point likert scale, with 0 indicating "not at all" and 4 indicating, "very much" in response to item questions. Total sub-scale range is 0 to 30, with higher scores indicating better well-being.

VA Office of Research and Development

Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.

Subjects in the first group ("Life Completion") will complete a psychosocial intervention which consists of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.

Life Completion: Subjects will discuss life review, issues of forgiveness and heritage and legacy.

Outlook Intervention

The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.

Subjects in the third group ("treatment as usual") will be exposed to no intervention or attention control during the intervention window.

Treatment as Usual

Subjects in the first group ("Outlook Intervention") completed a psychosocial intervention which consists of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on issues of heritage and legacy.

Life Completion: Subjects will discuss life review, issues of forgiveness and heritage and legacy.

Arm 1 -Outlook Intervention

The subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.

Attention Control: Subjects will listen to a non-guided relaxation CD

Arm 2 Attention Control

Subjects in the third group ("Treatment as Usual") were exposed to no intervention or attention control during the intervention window.

Arm 3 Treatment as Usual

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

High (greater or = 70)

Low (less or = 60)

The Palliative Performance Scale was used to assess functional status of participants. It was used as a stratification variable in randomization to assure that all arms of the trial had equal numbers of participants at similar levels of functional abilities, and illness severity. Scale range is 0 -100 where higher numbers indicate higher function.

Palliative Performance Scale - Stratification variable

Less than High School (HS) degree

HS degree or GED

Some college, associate, trade school

Bachelor's degree

some graduate/professional or higher degree

Highest level of Education

Christian

Other

Not a member of a religion

Missing

Religion

Difficulty paying the bills

Money to pay bills but need to cut back

Pay bills but little spare money

Have enough money for special things

Financial Status

Working for pay, part or full-time

Not working

Retired

Disability

Working Status

A total of 261 Durham VAMC patients with serious life-limiting disease were consented, and 221 were randomized to the study. Seventy-five were randomized to the Life completion intervention, 74 to the active control intervention, and 72 to the usual care control group.

Karen Steinhauser, PhD

Baseline mean

5 week follow up

7 week follow up

Participants received the Outlook Intervention

Participants received a relaxation meditation as attention control

Participants received no intervention, but rather care as usual

QUAL-E - Preparation Sub-scale

Baseline

5 Weeks

7 Weeks

Participants received the Outlook intervention

Participants received a relaxation meditation as attention control condition.

Participants received no intervention but rather care as usual.

POMS Anxiety Sub-scale

5 week

7 Week

Participants received a relaxation meditation as the attention control condition.

Participants did not receive any intervention but rather care as usual.

Arm 3 Usual Care

CES-D

Baselin

Participants received a relaxation meditation as the attention control condition

FACIT-SP

5 weeks

7 weeks

Participants received a relaxation meditation as attention control.

Participants received no intervention, but rather care as usual.

QUAL-E Life Completion Sub-scale

Participants received relaxation meditation as the attention control condition

FACT-G - Social Sub-scale

Subjects in the first group ("Outlook Intervention") completed a psychosocial intervention which consisted of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy.

Subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.

Attention Control: Subjects will listen to a non-guided relaxation CD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Follow-up Patients With End Stage Renal Disease Undergoing Hemodialysis, Receiving Selective Vitamin D Receptor Activator's for Prevention and Treatment of Secondary Hyperparathyroidism	NCT01149291	Secondary Hyper... End Stage Renal...		18 Years -	AbbVie
Outlook Quality of Life Intervention Study	NCT01044290	Cancer Congestive Hear... Chronic Obstruc... End Stage Renal...	Life Completion Attention Contr...	18 Years - 95 Years	VA Office of Research and Development

Spots Global Cancer Trial Database for end stage renal disease (esrd)