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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
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Type 2 diabetes
  2. Age between 18-75 years inclusive
  3. Chinese ethnicity
  4. 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:

  1. Failure to have 100% attendance rate in the peer supporters training program
  2. Inadequate knowledge about diabetes after training program as judged by study investigators

Exclusion criteria for the peers:

  1. No access to telephone
  2. Unable to speak Cantonese
  3. Unable to understand the scope of the project
  4. Serious mental or physical disability that prevents one from meeting and communicating regularly with peer supporter
  5. Serious medical illness with expected life expectancy < 1 years such as terminal cancer
  6. 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

    First Posted
    June 24, 2015
    Last Updated
    June 26, 2015
    Sponsor
    Chinese University of Hong Kong
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    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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