Diabetes Mellitus, Type 2 Clinical Trial
— BEYOOfficial title:
A Strengths-based Intervention Based on Salutogenic Theory to Promote Sense of Coherence and Self-care of Elderly People With Type 2 Diabetes
Verified date | July 2017 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 132 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: 1. A medical diagnosis of type 2 diabetes according to diagnostic criteria recommended by WHO (2006); 2. Older than aged 60 years; 3. Diagnosed with diabetes at least six months before the intervention; 4. Residing in the community, able to read and communicate in Chinese; 5. Having intact cognitive function as indicated by the Abbreviated Mental Test of score >=6; 6. Having some degree of self-care deficit as indicated by the Chinese version of SDSCA of score <=23. Exclusion Criteria: 1. Presence of serious mental problem or terminal illness; 2. Previously participated in similar programs; 3. Visual or audio impaired. |
Country | Name | City | State |
---|---|---|---|
China | He Xinyuan Community Health Care Center | Changsha | Hunan |
China | Yannong Neighborhood Health Care Clinics | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | the Chinese version of the Audit of Diabetes Dependent Quality of Life (CN-ADDQoL) | The ADDQoL is a diabetes-specific health related quality of life instrument (Bradley et al., 1999) assessed perceived impact of diabetes on 19 life domains containing physical functioning, symptoms, psychological well-being, social well-being, role activities and personal construct. | 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 | |
Secondary | Diabetes Distress Scale (DDS) | The DDS is developed by Polonsky et al (2005) to assess diabetes-related emotional distress. DDS contains 17 items to cover 4 dimensions: emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal distress. | 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 | |
Secondary | Diabetes Self-Efficacy Scale (DSES) | DSES was developed by Stanford Patient Education Research Center (Lorig et al., 2009), including 8 items to assess patients' confidence in areas including dietary, exercise and symptom management. | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |