the Peer-Led Self-Management Program

Diabetes Clinical Trial

Official title:

Effects of the Peer-Led Self-Management Program (PLSM) on Self-Efficacy, Self-Management and Physiological Measures Among Elderly Patients With Diabetes: Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04298424
• Other study ID #: 17B-023
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2020
• Source: St. Martin De Porress Hospital
• Contact: Wen-Chun Chen, Chief, Master
• Phone: +886-5-2756000
• Email: shermie[@]stm.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Elderly patients have the deficiency of motivation and confidence in self-management that are mainly influenced by physiological function, social psychology, emotion and low health literacy, resulting in poor self-management and glycemic control. According to the study, elderly patients can learn the skill of self-management more effectively through the peer leaders who have the same culture background, the life experience in disease care and the successful self-management experiences. The Self-Management Program of diabetes for the elderly will be in progress with the peer leadership concept.( the Peer-Led Self-Management Program). The aim of the pilot study was to explore the feasibility and effects of the Peer-Led Self-Management Program (PLSM).

This pilot study uses two groups of block randomized controlled trials with pretest and posttest study. The test group will conduct a four-week Peer-Led Self-Management Program and the general outpatient care while the control group will implement the general outpatient care. In this study, the physiological parameters of Diabetes were used to evaluate the difference between the pre-and post-intervention measures.

Description:

Most current self-management programs are developed for implementation by healthcare professionals. These professionals cannot fully perceive disease management needs and obstacles of older adults due to a lack of similar illness experience. To develop a self-management training program for older adult peer leaders with diabetes and to assess its feasibility.

This study was conducted in three stages. In stage 1, the peer leader training program was developed using experiential learning theory as the framework and self-regulation theory as the strategy for activity design. The 4-week training program was implemented for 4 hours/week. In stage 2, the feasibility of the training program was assessed. A peer leader training assessment tool was developed and used to evaluate peer leaders' leadership skills for self-management programs. Peer leaders' attendance rate and their viewpoints toward the training program through qualitative interview, willingness to lead self-management programs for older adults with diabetes in the community in the future were also assessed. In stage 3, This pilot study will take elderly diabetic patients in a community health station in Taiwan. The program will be conducted by peer leaders who have completed training to lead elderly diabetic patients and promote interaction, sharing, and support among peers. Improve self-confidence by guiding elderly diabetic patients to reflect on past self-management challenges and share successful self-management experiences. At the same time, learn how to find self-management problems, set goals and develop action plans, and other strategies to help elderly patients with diabetes set goals for their own health problems, develop and implement self-suitable, feasible and sustainable self-management behaviors to strengthen Self-management skills for elderly diabetic patients. The 4-week program was implemented for 2 hours/week.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• age = 65 years,older adult peer leaders with diabetes, elementary school or higher level of education,

Exclusion Criteria:

• People with cognitive impairment, severe diabetes complications

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Older Adults
• Self-Efficacy
• Self-Management

Intervention

Other:
• PLSM
The program was designed for implementation over 4 consecutive weeks, with groups of 6-8 people each attending one 60-90-minute class per week. Peer leaders lead the groups to promote interaction, sharing, and support, and assist in goal setting to address behavior-related health problems, and thereby the development and implementation of strategies to achieve suitable, sustainable, and feasible self-management behavior.

Locations

Country	Name	City	State
Taiwan	St. Martin De Porres Hospital	Chiayi City

Sponsors (1)

Lead Sponsor	Collaborator
St. Martin De Porress Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1C	Hemoglobin A1c, HbA1c	Change from Baseline HbA1C at 3 months
Secondary	Self-Management Score	Diabetes Self-Management Instrument Short Form, DSMI-20	Change from Baseline Self-Management Score at 3 months
Secondary	Self-Efficacy Score	The Diabetes Management Self-Efficacy Scale, DMSES	Change from Baseline Self-Efficacy Score at 3 months