Chronic DiseaseCDSMP-ILNCT07367750
Testing the Feasibility of a Self-Management Support Program for Patient With Chronic Diseases in Israel
A study testing Chronic Disease Self-Management Program (CDSMP) in people with Chronic Disease and Kidney Transplantation, run by University of Haifa at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Disease, Kidney Transplantation, Cancer Survivorship
- What is being tested?
- Chronic Disease Self-Management Program (CDSMP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2025to 28 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years or older
- Diagnosed with at least one chronic disease (as documented in the medical record)
- Community-dwelling
- Fluent in Hebrew
Who cannot join
- Documented cognitive impairment
- Diagnosis of major depression or other psychiatric disorder (based on self-report or medical records)
- Hospitalization in the past 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nirit Rotem-Lerer contact
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv
Nirit Rotem-Lerer, +97236974676, niritrl@tlvmc.gov.il
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Chronic Disease, Kidney Transplantation, Cancer Survivorship
- Being tested
- Chronic Disease Self-Management Program (CDSMP)
- Keywords
- Chronic Disease, Self-Management, CDSMP, Kidney, Transplantation, Cancer Survivors
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Disease Self-Management Program (CDSMP)Behavioural
Also called Chronic Disease Self-Management Program(CDSMP)
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.
| Study group | Role | What they receive |
|---|---|---|
| CDSMP Group | Experimental | 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 Receives: Behavioral: Chronic Disease Self-Management Program (CDSMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Activation Measure (PAM-13)
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.
Measured: Baseline, immediately post-intervention, 6-month follow-up
health-related behaviors
Assessed using a custom self-report questionnaire developed by the research team, covering physical activity, nutrition, medication adherence, and use of health services.
Measured: Baseline, immediately post-intervention, 6-month follow-up
chronic disease symptom burden
Evaluated using the Self-Management Resource Center (SMRC) symptom survey, which includes ratings of fatigue, pain, emotional distress, sleep, depression, anxiety, and social isolation.
Measured: Baseline, immediately post-intervention, 6-month follow-up
health-related quality of life (EQ-5D)
Baseline, immediately post-intervention, 6-month follow-up
Measured: Measured by the EQ-5D instrument, which assesses five dimensions of functioning and includes a global self-rated health visual analogue scale.
Secondary outcomes (3)
Themes from focus group analysis regarding participant experience
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.
Measured: through study completion, an average of 6-month
Perceived facilitators and barriers to self-management
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.
Measured: through study completion, an average of 6-month
Participant suggestions for improving the CDSMP
Within one month after program completion
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Feb 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion28 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galit Yogev-Seligmann, University of Haifa
- Investigators
- Galit Yogev-Seligmann, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367750
- Sponsor's protocol ID
- 0703-24-TLV
- Other IDs
- no funding
- Acronym
- CDSMP-IL
- Status last verified
- Apr 2026
- First submitted
- 25 Sep 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy considerations and the sensitive nature of the self-reported health and behavioral data collected. No plans for data sharing have been established at this time.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Self-Management Support Program Among People With Kidney Transplant and Cancer Survivors in Israel: Testing Feasibility and Effects
- ClinicalTrials.gov ID
- NCT07367750
- Acronym / sponsor ID
- CDSMP-IL / 0703-24-TLV
- Conditions
- Chronic Disease, Kidney Transplantation, Cancer Survivorship
- Keywords
- Chronic Disease, Self-Management, CDSMP, Kidney, Transplantation, Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDSMP Group | Experimental | Behavioral: Chronic Disease Self-Management Program (CDSMP)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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21 years or older
- Diagnosed with at least one chronic disease (as documented in the medical record)
- Community-dwelling
- Fluent in Hebrew
Key exclusion criteria (3 listed)
- Documented cognitive impairment
- Diagnosis of major depression or other psychiatric disorder (based on self-report or medical records)
- Hospitalization in the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic Disease Self-Management Program (CDSMP)Also: Chronic Disease Self-Management Program(CDSMP)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. | Behavioural | CDSMP Group |
Primary outcome
Patient Activation Measure (PAM-13)
Time frame: Baseline, immediately post-intervention, 6-month follow-up
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.
health-related behaviors
Time frame: Baseline, immediately post-intervention, 6-month follow-up
Assessed using a custom self-report questionnaire developed by the research team, covering physical activity, nutrition, medication adherence, and use of health services.
chronic disease symptom burden
Time frame: Baseline, immediately post-intervention, 6-month follow-up
Evaluated using the Self-Management Resource Center (SMRC) symptom survey, which includes ratings of fatigue, pain, emotional distress, sleep, depression, anxiety, and social isolation.
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.
Baseline, immediately post-intervention, 6-month follow-up
3 secondary outcomes
Themes from focus group analysis regarding participant experience
Time frame: through study completion, an average of 6-month
Perceived facilitators and barriers to self-management
Time frame: through study completion, an average of 6-month
Participant suggestions for improving the CDSMP
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy considerations and the sensitive nature of the self-reported health and behavioral data collected. No plans for data sharing have been established at this time.
Related trials for Chronic Disease
RecruitingPhase 1
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
AML, Multiple Myeloma
RecruitingPhase 2/3
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Not yet recruitingPhase 4
Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
Chronic Subdural Hematoma
Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
Not yet recruiting
Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
End Stage Kidney Disease (ESKD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nirit Rotem-Lerer contact
Galit Yogev-Seligmann principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic Disease Self-Management Program (CDSMP) in people with Chronic Disease and Kidney Transplantation, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Galit Yogev-Seligmann (+972535315761, galit.yogev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation Measure (PAM-13) (time frame: Baseline, immediately post-intervention, 6-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.