Multi-centre Peer Support Program in Type 2 Diabetes Patients in Hong Kong
Primary Purpose
Type 2 Diabetes, Peer Group
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Peer support program
Sponsored by
About this trial
This is an interventional health services research trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes
- Age between 18-75 years inclusive
- Chinese ethnicity
- High risk patients for poor diabetes control based on the self-administered questionnaire designed by the study team
Exclusion Criteria:
Exclusion criteria for peer supporters:
- Failure to have 100% attendance rate in the peer supporters training program
- Inadequate knowledge about diabetes after training program as judged by study investigators
Exclusion criteria for the peers:
- No access to telephone
- Unable to speak Cantonese
- Unable to understand the scope of the project
- Serious mental or physical disability that prevents one from meeting and communicating regularly with peer supporter
- Serious medical illness with expected life expectancy < 1 years such as terminal cancer
- Participation in any diabetes quality improvement program in the past 2 years such as peer support program, Joint Asia Diabetes Evaluation Program
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Peer supporter
Arm Description
Peer support program
Outcomes
Primary Outcome Measures
Glycaemic control
the HbA1c change at 12 months in peers group
Secondary Outcome Measures
Depressive symptoms
the change in the marks of 8-item Patient Health Questionnaire (Chinese version) at 12 months in both peers and peer supporters
Diabetes distress
the change in the marks of Chinese Diabetes Distress Scale (CDDS-15) at 12 months in both peers and peer supporters
Quality of life
the change in the marks of the World Health Organization quality of life questionnaire (WHO-QoL-26) at 12 months in peers and peer supporters
Body weight
the change in body mass index at 12 months in both peers and peer supporters
Full Information
NCT ID
NCT02486172
First Posted
June 24, 2015
Last Updated
June 26, 2015
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02486172
Brief Title
Multi-centre Peer Support Program in Type 2 Diabetes Patients in Hong Kong
Official Title
Development and Evaluation of A Peer Support Program for Type 2 Diabetes Patients in Hong Kong as Quality Improvement in Diabetes Care Service
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pre-and-post study with a study duration of one year involving 7 diabetes centres in Hong Kong. A group of motivated patients with type 2 diabetes will be trained as peer supporters in two training workshops. Patients who may benefit from peer support program will be recruited as peers. In the one year study period, peer supporters are required to have 2 face-to-face interviews and 12 phone calls. Clinical parameters and psycho-behavioral parameters of both peer supporters and peers will be evaluated at the baseline and at the end of the study.
Detailed Description
Aim of the Study:
To evaluate the impact of peer support program on various clinical, psycho-behavioral outcomes and health utilization outcomes in Hong Kong Chinese with type 2 diabetes
To evaluate the feasibility of a peer support program in Hong Kong
To evaluate the sustainability of a peer support program in Hong Kong
Duration of the program = 12 months
Indicators and targets:
Number of peer supporters recruited: 12
Number of peers recruited = 50
Number of peer supporter training sessions = 2
Number of reunion sessions for peer supporters with the investigators = 4
Minimum number of telephone calls made by peer supporter = 12 for each peer
Method:
The diabetes nurses from 7 diabetes centres of public hospitals in Hong Kong will recruit peer supporters and peers in the first 3 months of the project.
Nurses will compile list of potential patients to invite to become peer supporters.
Selected potential peer supporters will attend 2 half-day training sessions by the diabetes nurses and social workers from the Community Rehabilitation Network according to specially-designed curriculum. In sum, it includes revision of diabetes knowledge, self-management, lifestyle modification, debriefing and rapport building skills. Patients will be evaluated at the end of the training course by social workers and nurses to ensure they are ready to be peer supporters.
Diabetes nurses will recruit patients as peers when they attend to the diabetes centre for routine diabetes care services such as complication screening, diabetes group education and nurse-led clinics.
Each peer supporter will be matched to 5 peers in the beginning. In case when the peer supporter quitted before the study ends, his/her peers will be directed to another peer support group. The maximum number of peers in each support group is 6.
A 2-hour face-to-face introduction of the peer supporters and peers will be held at the diabetes centre when the study begins.
Peer supporters will be expected to carry out a minimum of12 phone calls over the next 12 months (one call every 2 weeks for 3 months; one call every month for the second 3 months, one call every 2 months for the last 6 months). Calls will be guided by a call checklist. Both peer supporters and peers will be encouraged to call one another ad lib. Peer supporters will return checklists to the program coordinator, recording the frequency, length, and nature of their interactions with peers
In the first month of the peer support group, social workers from the Community Rehabilitation Network will contact peer leaders by phone to further foster the peer leader to be committed to the program and to increase their confidence in supporting their peers.
Two large gatherings for all participants will be organized by the investigators at around 4-8 months after the study and near to the study completion.
All peer supporters and peers will receive usual medical follow-up at their original clinics.
Peer supporters will have reunion workshop at the diabetes centre with the nursing team and social worker every 2 months throughout the intervention. The workshop will last around 1 hour and it will address any issues the peer supporters encounter, provide some educational by a medical professional, and will facilitate sharing amongst peer supporters to develop a peer supporter network.
Surveys for peer supporters and involved staff will also be collected during the debriefing sessions to identify difficulties peer supporters are facing and to better inform ongoing training and education. Surveys will also be administered to peers at the end of the study to obtain opinions and suggestions about their peer support experience.
The intervention duration will be 12 months. However peers are encouraged to keep regular contact with peer leaders even after the intervention period ends.
A focus-group interview will be conducted by a trained psychologist to two of the peer groups to evaluate participants' satisfaction
Progress tracking:
Clinical, behavioral, and psychological data will be collected at baseline and at the end of the study (12 months):
Clinical measures to be done in introduction session and in the second large group gathering: Blood pressure Adiposity (body weight, waist circumference and body mass index)
Biochemical measures (HbA1c and lipid profile) were retrieved via the hospital Central Computer System within 2 months of the study starting date and the end date
Psychological measures, using validated self-administered questionnaires, to be completed in introduction session and in the second large group gathering:
World Health Organization quality of life questionnaire (WHO-QoL-26) for quality of life 15-item Chinese Diabetes Distress Scale (CDDS-15) for diabetes distress 8-item Patient Health Questionnaire for depressive symptoms EQ5D for quality of life Summary of Diabetes Self Care Activities (SDSCA) for adherence to diabetes self-care
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Peer Group
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
434 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peer supporter
Arm Type
Other
Arm Description
Peer support program
Intervention Type
Behavioral
Intervention Name(s)
Peer support program
Intervention Description
Peer support program as an additional service to the routine clinical service
Primary Outcome Measure Information:
Title
Glycaemic control
Description
the HbA1c change at 12 months in peers group
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Depressive symptoms
Description
the change in the marks of 8-item Patient Health Questionnaire (Chinese version) at 12 months in both peers and peer supporters
Time Frame
12 months
Title
Diabetes distress
Description
the change in the marks of Chinese Diabetes Distress Scale (CDDS-15) at 12 months in both peers and peer supporters
Time Frame
12 months
Title
Quality of life
Description
the change in the marks of the World Health Organization quality of life questionnaire (WHO-QoL-26) at 12 months in peers and peer supporters
Time Frame
12 months
Title
Body weight
Description
the change in body mass index at 12 months in both peers and peer supporters
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Dropout rates of the peer supporters and peers
Description
Dropout rates of the peer supporters and peers
Time Frame
12 months
Title
Sustainability of the program
Description
Percentage of peers who still have regular contact with their respective peer supporters after the completion of the program
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes
Age between 18-75 years inclusive
Chinese ethnicity
High risk patients for poor diabetes control based on the self-administered questionnaire designed by the study team
Exclusion Criteria:
Exclusion criteria for peer supporters:
Failure to have 100% attendance rate in the peer supporters training program
Inadequate knowledge about diabetes after training program as judged by study investigators
Exclusion criteria for the peers:
No access to telephone
Unable to speak Cantonese
Unable to understand the scope of the project
Serious mental or physical disability that prevents one from meeting and communicating regularly with peer supporter
Serious medical illness with expected life expectancy < 1 years such as terminal cancer
Participation in any diabetes quality improvement program in the past 2 years such as peer support program, Joint Asia Diabetes Evaluation Program
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Yee-Man Wong, MSC (Health Care)
Phone
852-2362 3124
Email
wongrym@ha.org.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Rose Zhao-Wei Ting, MBBS (HKU)
Phone
852-2362 3124
Email
ting_rose@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Yee-Man Wong, BSc (Nurs)
Organizational Affiliation
HKIDO, CUHK
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24716255
Citation
Peer Support for Diabetes, Heart Disease and HIV/AIDS: A Review of the Clinical Effectiveness, Cost-effectiveness, and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2013 Nov 8. Available from http://www.ncbi.nlm.nih.gov/books/NBK195174/
Results Reference
background
PubMed Identifier
20483801
Citation
Boothroyd RI, Fisher EB. Peers for progress: promoting peer support for health around the world. Fam Pract. 2010 Jun;27 Suppl 1:i62-8. doi: 10.1093/fampra/cmq017.
Results Reference
background
PubMed Identifier
22804713
Citation
Dale JR, Williams SM, Bowyer V. What is the effect of peer support on diabetes outcomes in adults? A systematic review. Diabet Med. 2012 Nov;29(11):1361-77. doi: 10.1111/j.1464-5491.2012.03749.x.
Results Reference
background
PubMed Identifier
22061095
Citation
Due-Christensen M, Zoffmann V, Hommel E, Lau M. Can sharing experiences in groups reduce the burden of living with diabetes, regardless of glycaemic control? Diabet Med. 2012 Feb;29(2):251-6. doi: 10.1111/j.1464-5491.2011.03521.x.
Results Reference
background
PubMed Identifier
24781960
Citation
Chan JC, Sui Y, Oldenburg B, Zhang Y, Chung HH, Goggins W, Au S, Brown N, Ozaki R, Wong RY, Ko GT, Fisher E; JADE and PEARL Project Team. Effects of telephone-based peer support in patients with type 2 diabetes mellitus receiving integrated care: a randomized clinical trial. JAMA Intern Med. 2014 Jun;174(6):972-81. doi: 10.1001/jamainternmed.2014.655.
Results Reference
background
PubMed Identifier
23938133
Citation
Zhang Y, Ting R, Lam M, Lam J, Nan H, Yeung R, Yang W, Ji L, Weng J, Wing YK, Sartorius N, Chan JCN. Measuring depressive symptoms using the Patient Health Questionnaire-9 in Hong Kong Chinese subjects with type 2 diabetes. J Affect Disord. 2013 Nov;151(2):660-666. doi: 10.1016/j.jad.2013.07.014. Epub 2013 Jul 31.
Results Reference
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Multi-centre Peer Support Program in Type 2 Diabetes Patients in Hong Kong
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