Testing the Feasibility of a Self-Management Support Program for Patient With Chronic Diseases in Israel

Официальное название

Implementation of a Self-Management Support Program Among People With Kidney Transplant and Cancer Survivors in Israel: Testing Feasibility and Effects

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Patient Activation Measure (PAM-13) [Срок оценки: Baseline, immediately post-intervention, 6-month follow-up]
• health-related behaviors [Срок оценки: Baseline, immediately post-intervention, 6-month follow-up]
• chronic disease symptom burden [Срок оценки: Baseline, immediately post-intervention, 6-month follow-up]
• health-related quality of life (EQ-5D) [Срок оценки: Measured by the EQ-5D instrument, which assesses five dimensions of functioning and includes a global self-rated health visual analogue scale.]

Вторичные конечные точки (3)

• Themes from focus group analysis regarding participant experience [Срок оценки: through study completion, an average of 6-month]
• Perceived facilitators and barriers to self-management [Срок оценки: through study completion, an average of 6-month]
• Participant suggestions for improving the CDSMP [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Age 21 years or older
• Diagnosed with at least one chronic disease (as documented in the medical record)
• Community-dwelling
• Fluent in Hebrew

Критерии исключения

• Documented cognitive impairment
• Diagnosis of major depression or other psychiatric disorder (based on self-report or medical records)
• Hospitalization in the past 3 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Израиль · 1 центр

• Tel Aviv Sourasky Medical Center — Tel Aviv

Идентификаторы

NCT: NCT07367750 · 0703-24-TLV · no funding

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗