跳至主要内容
临床试验/NCT07367750
NCT07367750招募中不适用

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

University of Haifa1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1
主要终点
Patient Activation Measure (PAM-13)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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

干预措施: Chronic Disease Self-Management Program (CDSMP) (Behavioral)

结局指标

主要结局

Patient Activation Measure (PAM-13)

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Galit Yogev-Seligmann

researcher, Senior Lecturer

University of Haifa

研究点 (1)

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