Type 2 DiabetesNCT02486172
Multi-centre Peer Support Program in Type 2 Diabetes Patients in Hong Kong
A study testing Peer support program in people with Type 2 Diabetes and Peer Group, run by Chinese University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Peer Group
- What is being tested?
- Peer support program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Failure to have 100% attendance rate in the peer supporters training program
- Inadequate knowledge about diabetes after training program as judged by study investigators
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Conditions
- Type 2 Diabetes, Peer Group
- Being tested
- Peer support program
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer support programBehavioural
Peer support program as an additional service to the routine clinical service
| Study group | Role | What they receive |
|---|---|---|
| Peer supporter | Other | Peer support program Receives: Behavioral: Peer support program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic control
the HbA1c change at 12 months in peers group
Measured: 12 months
Secondary outcomes (4)
Depressive symptoms
the change in the marks of 8-item Patient Health Questionnaire (Chinese version) at 12 months in both peers and peer supporters
Measured: 12 months
Diabetes distress
the change in the marks of Chinese Diabetes Distress Scale (CDDS-15) at 12 months in both peers and peer supporters
Measured: 12 months
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
Measured: 12 months
Body weight
the change in body mass index at 12 months in both peers and peer supporters
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Yee-Man Wong, Chinese University of Hong Kong
- Investigators
- Rebecca Yee-Man Wong, BSc (Nurs), Principal investigator, HKIDO, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486172
- Sponsor's protocol ID
- CRE Ref. No. 2014.513_FR
- Status last verified
- Jun 2015
- First submitted
- 24 Jun 2015
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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/
PubMed 24716255Boothroyd 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.
PubMed 20483801Dale 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.
PubMed 22804713Due-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.
PubMed 22061095Chan 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.
PubMed 24781960Zhang 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.
PubMed 23938133
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02486172
- Acronym / sponsor ID
- CRE Ref. No. 2014.513_FR
- Conditions
- Type 2 Diabetes, Peer Group
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer supporter | Other | Behavioral: Peer support programPeer support program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Failure to have 100% attendance rate in the peer supporters training program
- Inadequate knowledge about diabetes after training program as judged by study investigators
- No access to telephone
- Unable to speak Cantonese
- Unable to understand the scope of the project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer support programPeer support program as an additional service to the routine clinical service | Behavioural | Peer supporter |
Primary outcome
Glycaemic control
Time frame: 12 months
the HbA1c change at 12 months in peers group
4 secondary outcomes
Depressive symptoms
Time frame: 12 months
Diabetes distress
Time frame: 12 months
Quality of life
Time frame: 12 months
Body weight
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
- Background: PubMed 24716255Peer 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/
- Background: PubMed 20483801Boothroyd 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.
- Background: PubMed 22804713Dale 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.
- Background: PubMed 22061095Due-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.
- Background: PubMed 24781960Chan 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.
- Background: PubMed 23938133Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Yee-Man Wong, BSc (Nurs) principal investigator
HKIDO, CUHK
Questions about this trial
What is this clinical trial studying?
A study testing Peer support program in people with Type 2 Diabetes and Peer Group, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Yee-Man Wong, MSC (Health Care) (852-2362 3124, wongrym@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemic control (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02486172, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2015.