- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07367750
Testing the Feasibility of a Self-Management Support Program for Patient With Chronic Diseases in Israel (CDSMP-IL)
Implementation of a Self-Management Support Program Among People With Kidney Transplant and Cancer Survivors in Israel: Testing Feasibility and Effects
This study explores an intervention to support people in Israel who are living with chronic health conditions such as cancer or after kidney transplantation. It focuses on a well-known international program called the Chronic Disease Self-Management Program (CDSMP), which was developed at Stanford University. The program helps individuals build confidence and skills to better manage their health, feel more in control, and improve their day-to-day quality of life.
Participants will take part in a six-week group program, delivered online, where they will learn practical strategies for managing symptoms like fatigue or pain, setting achievable health goals, communicating effectively with healthcare professionals, and staying active and engaged. The sessions are guided by trained facilitators and include support from others facing similar health challenges.
The study will involve surveys before and after the program, as well as a follow-up six months later, to understand how the program may have helped participants. Some participants will also be invited to share their experiences in small discussion groups.
By testing this program in Israel, the researchers hope to learn how it can be adapted and offered more widely to help others living with chronic conditions.
Study Overview
Status
Intervention / Treatment
Detailed Description
This mixed-methods pilot study aims to evaluate the feasibility, acceptability, and potential impact of implementing the Chronic Disease Self-Management Program (CDSMP) in Israel. The CDSMP is an internationally recognized, evidence-based intervention originally developed at Stanford University to support individuals living with chronic health conditions. It is designed to improve self-efficacy, promote health-enhancing behaviors, and reduce the personal and healthcare burden associated with chronic illness.
The study will be conducted among adults with chronic conditions, specifically kidney transplant recipients and cancer survivors, recruited from a major tertiary care center(tel aviv sourasky medical center). Participants will take part in a 6-week group-based intervention delivered online in weekly 2.5-hour sessions. The sessions are led by trained facilitators certified in the CDSMP protocol and emphasize collaborative learning and peer support.
The program covers a range of self-management topics, including symptom management (e.g., fatigue, pain, sleep disturbances), medication adherence, physical activity, healthy eating, emotional coping, and communication with healthcare professionals. Participants are encouraged to engage in weekly action planning, goal setting, and problem-solving.
Quantitative data will be collected using validated self-report instruments at three time points: before the intervention, immediately after, and six months post-completion. These assessments will examine patient activation, engagement in health behaviors, symptom burden, and health-related quality of life.
In parallel, qualitative data will be gathered through focus groups with a subset of participants to capture their experiences and perspectives on the program. These discussions will explore perceived benefits, barriers to participation, and the program's impact on day-to-day functioning. Thematic analysis will be performed to identify key insights that may inform future adaptations and implementation strategies.
Findings from this pilot study will inform the potential for broader integration of the CDSMP into Israel's healthcare system and identify any cultural or operational adjustments needed for local relevance and sustainability.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Galit Yogev-Seligmann
- Phone Number: +972535315761
- Email: galit.yogev@gmail.com
Study Contact Backup
- Name: Nirit Rotem-Lerer
- Email: galit.yogev@gmail.com
Study Locations
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Tel Aviv, Israel
- Recruiting
- Tel Aviv Sourasky Medical Center
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Contact:
- Nirit Rotem-Lerer
- Phone Number: +97236974676
- Email: niritrl@tlvmc.gov.il
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 21 years or older
- Diagnosed with at least one chronic disease (as documented in the medical record)
- Community-dwelling
- Fluent in Hebrew
Exclusion Criteria:
- Documented cognitive impairment
- Diagnosis of major depression or other psychiatric disorder (based on self-report or medical records)
- Hospitalization in the past 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: CDSMP Group
Participants with chronic diseases (kidney transplant recipients or cancer survivors) will participate in the Chronic Disease Self-Management Program (CDSMP), a six-week online group intervention
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A structured, peer-led, six-week online intervention developed at Stanford University to enhance self-management skills in individuals with chronic conditions.
Sessions include action planning, symptom management, medication adherence, healthy behaviors, and emotional coping.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient Activation Measure (PAM-13)
Time Frame: Baseline, immediately post-intervention, 6-month follow-up
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The Patient Activation Measure (PAM-13) is a validated self-report questionnaire that assesses individuals' knowledge, skills, and confidence in managing their health.
Higher scores reflect greater activation and self-management ability.
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Baseline, immediately post-intervention, 6-month follow-up
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health-related behaviors
Time Frame: Baseline, immediately post-intervention, 6-month follow-up
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Assessed using a custom self-report questionnaire developed by the research team, covering physical activity, nutrition, medication adherence, and use of health services.
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Baseline, immediately post-intervention, 6-month follow-up
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chronic disease symptom burden
Time Frame: Baseline, immediately post-intervention, 6-month follow-up
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Evaluated using the Self-Management Resource Center (SMRC) symptom survey, which includes ratings of fatigue, pain, emotional distress, sleep, depression, anxiety, and social isolation.
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Baseline, immediately post-intervention, 6-month follow-up
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health-related quality of life (EQ-5D)
Time Frame: Measured by the EQ-5D instrument, which assesses five dimensions of functioning and includes a global self-rated health visual analogue scale.
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Baseline, immediately post-intervention, 6-month follow-up
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Measured by the EQ-5D instrument, which assesses five dimensions of functioning and includes a global self-rated health visual analogue scale.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Themes from focus group analysis regarding participant experience
Time Frame: through study completion, an average of 6-month
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Semi-structured focus groups will be conducted with a subset of participants to explore their perceptions of the program's relevance, usefulness, cultural fit, and overall impact on daily life.
Audio recordings will be transcribed and analyzed thematically using a structured multi-stage coding process.
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through study completion, an average of 6-month
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Perceived facilitators and barriers to self-management
Time Frame: through study completion, an average of 6-month
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Identified from qualitative data in focus group discussions.
Participants will describe what helped or hindered their ability to engage in self-management behaviors following the intervention.
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through study completion, an average of 6-month
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Participant suggestions for improving the CDSMP
Time Frame: through study completion, an average of 1 year
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Within one month after program completion
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through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Galit Yogev-Seligmann, University of Haifa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0703-24-TLV
- No funding (Other Identifier: No issuing organization)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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