BEYO Project to Promote Sense of Coherence and Self-care of Elderly People With Type 2 Diabetes

NCT03237975 | Unknown

• 1 other identifier: BEYO Project-LYCUHK
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

1. 1.Objectives of the Project
2. 2.Content of the Project

Conditions

Diabetes Mellitus, Type 2; Sense of Coherence; Self Care; Strengths-based Intervention

Keywords

type 2 diabetes; sense of coherence; self-care; strengths-based intervention

Outcome Measures

Primary Outcomes (6)

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

  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.

  From the date of recruitment, until the date of randomization, up to 2 weeks

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

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

  From the date of recruitment, until the date of randomization, up to 2 weeks

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

  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.

  5 weeks after the project started

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

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

  5 weeks after the project started

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

  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.

  3-month after the project ended

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

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

  3-month after the project ended

Secondary Outcomes (3)

• 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

• 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

Study Arms (2)

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.

Behavioral: Be the Expert for Your Own (BEYO)

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.

Other: Routine health education

Interventions

Be the Expert for Your Own (BEYO) BEHAVIORAL

The BEYO program is structured adopting solution focused therapy (SFT). The basic principles for SFT are focusing on positive change and establishing groups driven by goals rather than problems. Solutions are generated through searching for strengths, skills, resources that working in clients' lives. The common flow for structured sessions contains 7 steps: 1) Health education; 2) Discuss self-care experience and identify deficit; 3) Describe exceptions; 4) Identify the strengths; 5) Miracle question and scaling; 6) Establish the solution; 7) Action plan.

Be the Expert for Your Own (BEYO)

Routine health education OTHER

The control group will receive routine health education.

Routine health education

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

He Xinyuan Community Health Care Center

Changsha, Hunan, 410000, China

Location

Yannong Neighborhood Health Care Clinics

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Yang Lei

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Assistant

Model Details: Participants were assigned to two groups in parallel for the duration of the study. One group received usual care for diabetes patients. One group received strengths-based intervention.

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: August 3, 2017
• Study Start: March 27, 2017
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 3, 2017

Record last verified: 2017-07

Locations

CN (2)