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临床试验/NCT03237975
NCT03237975Unknown不适用

A Strengths-based Intervention Based on Salutogenic Theory to Promote Sense of Coherence and Self-care of Elderly People With Type 2 Diabetes

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2017年3月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
132
试验地点
2
主要终点
the Chinese version of the Summary of Diabetes Self-Care Activities measure (SDSCA)

研究概览

简要总结

  1. Objectives of the Project

The BEYO project is designed based on the middle range theory of self-care of chronic illness and salutogenic theory. The aim of this project is to facilitate self-care behaviours of community-dwelling elderly patients with type 2 diabetes through promoting SOC, and accordingly improve their health outcomes, including promoting quality of life and reducing diabetes-related emotional distress. 2. Content of the Project

BEYO is a group-based consultation project. Each group contains 1 facilitator, 1 assistant and 8 elderly patients. 5 weekly sessions are provided to let patients receive health knowledge, discuss problems and experiences, explore available resources and build up goals and solutions. Each session lasts for 40 minutes. Session 1 aims to build social network among group members and introduce group goals and tasks. Session 2-4 covers six topics based on the Chinese guideline for type 2 diabetes released by Chinese diabetes society: (i) healthy dietary, (ii) exercise and activity, (iii) taking medication, (iv) blood glucose monitoring, (v) reducing risks for complication, (vi) healthy coping with mental stress. These middle sessions execute a common session flow to construct an action plan utilizing patients' resources and strengths to achieve the client-centered goal. Session 5 aims to review the process, summarize effective solutions, and set up plans for the future. One-week, one-month and three-month telephone follow-ups are delivered to help patients solve problems encountered during implementing the action plan and evaluate their self-care, SOC and other health outcomes.

详细描述

  1. Overall aims The aim of this study is to develop and evaluate the effects of a strengths-based group intervention called Be the Expert for Your Own (BEYO) among elderly patients with type 2 diabetes to facilitate their SOC and self-care, and accordingly improve their health outcomes.

  2. Study Design This study is designed to be a mixed method research incorporating both quantitative and qualitative components. A two-arm randomized controlled trial (RCT) will be conducted to assess the effects of a strengths-based group intervention compared with routine health education on SOC and self-care of elderly people with type 2 diabetes. The theoretical framework for BEYO program is based on salutogenic theory proposed by Antonovsky (1987). Qualitative study will be conducted at the end of the program to explore patients' experience about BEYO and the mechanism through which BEYO can facilitate self-care, in terms of what component and how.

  3. Be the Expert for Your Own (BEYO) program

  4. Overview The BEYO protocol consists of 5 structured sessions among intervention facilitator and 8 type 2 diabetes patients.The common flow for structured sessions contains 7 steps. Rationale and aims for designing each step are described as follows.

Step 1 - "Health education" As supported by the middle range theory and results from integrated review, knowledge acquisition is essential among patients with chronic disease to perform reflective, sufficient and reasoned self-care actions with a pattern. This step aims to equip patients with basic knowledge and essential skills to manage their disease.

Step 2 - "Discuss self-care experience and identify deficit" This step aims to collect basic information about clients' experience of performing self-care in each specific area and identify major problems they encounter in this process. This step facilitates information exchange and experience sharing among clients and provides reference for intervention facilitator about clients' basic situation. Besides, giving enough opportunity to describe the problem makes it easier to redirect the conversation later if attendees restart talking about the problem.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • A medical diagnosis of type 2 diabetes according to diagnostic criteria recommended by WHO (2006);
  • Older than aged 60 years;
  • Diagnosed with diabetes at least six months before the intervention;
  • Residing in the community, able to read and communicate in Chinese;
  • Having intact cognitive function as indicated by the Abbreviated Mental Test of score >=6;
  • Having some degree of self-care deficit as indicated by the Chinese version of SDSCA of score <=23.

排除标准

  • Presence of serious mental problem or terminal illness;
  • Previously participated in similar programs;
  • Visual or audio impaired.

研究组 & 干预措施

Be the Expert for Your Own (BEYO)

Experimental

BEYO is a group-based consultation project. Each group contains 1 facilitator, 1 assistant and 8 elderly patients. 5 weekly sessions are provided to let patients receive health knowledge, discuss problems and experiences, explore available resources and build up goals and solutions. Each session lasts for 40 minutes. Session 1 aims to build social network among group members and introduce group goals and tasks. Session 2-4 covers six topics: (i) healthy dietary, (ii) exercise and activity, (iii) taking medication, (iv) blood glucose monitoring, (v) reducing risks for complication, (vi) healthy coping with mental stress. Session 5 aims to review the process, summarize effective solutions, and set up plans for the future.

干预措施: Be the Expert for Your Own (BEYO) (Behavioral)

Routine health education

Active Comparator

To neutralize the effect of extra attention from the facilitator, participants in control group will receive routine health education on topics related to type 2 diabetes. Contents for the routine education will be based on the national guideline of basic public health service for diabetes and specific implementation protocols in each community. Participants in control group will receive 5-weekly education packet at the same time with participants in intervention group. The patients will not be given any strengths-based information, but they are free to discuss their disease status with nurses or physicians at their regular follow-up appointments.

干预措施: Routine health education (Other)

结局指标

主要结局

the Chinese version of the Summary of Diabetes Self-Care Activities measure (SDSCA)

时间窗: 3-month after the project ended

SDSCA is a brief self-report measure for assessing levels of self-care across different components of the diabetes regimen. The new version revised by Toobert's team (2000) uses 11 items to include 6 aspects of diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking.

Short form of the sense of coherence questionnaire (SOC-13)

时间窗: 3-month after the project ended

The SOC questionnaire was developed by Antonovsky (1987) to measure three components of sense of coherence: comprehensibility, manageability and meaningfulness.

次要结局

  • Diabetes Self-Efficacy Scale (DSES)(From the date of recruitment, until the date of randomization, up to 2 weeks; 5 weeks after the project started, 3-month after the project ended)
  • the Chinese version of the Audit of Diabetes Dependent Quality of Life (CN-ADDQoL)(From the date of recruitment, until the date of randomization, up to 2 weeks; 5 weeks after the project started; 3-month after the project ended)
  • Diabetes Distress Scale (DDS)(From the date of recruitment, until the date of randomization, up to 2 weeks; 5 weeks after the project started; 3-month after the project ended)

研究者

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

Lei Yang

Graduate Assistant

Chinese University of Hong Kong

研究点 (2)

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