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Type 2 Diabetes MellitusNCT03438617

Peer Support To Enhance The Shanghai Integration Model Of Diabetes Care: Extension & Dissemination

A study testing Peer Support in people with Type 2 Diabetes Mellitus, run by Shanghai 6th People's Hospital at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project developed a combined model of the Shanghai Integration Model and peer support for diabetes self-management education and support. The program was implemented and evaluated in nine Community Health Centers in Shanghai, China. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Peer Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,284 participants
Where
10 sitesChina
Study dates
8 Mar 2017to 11 Feb 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chinese
  • Has type 2 diabetes
  • Receiving treatment at participating community health center

Who cannot join

  • Severe mental illness (severe depression, schizophrenia, bipolar disorder, obsessive compulsive disorder, panic disorder, PTSD, borderline personality disorder, etc.)

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality, 200233

  • An Ting Community Health Center

    Shanghai, Shanghai Municipality

  • Cao Yang Community Health Center

    Shanghai, Shanghai Municipality

  • Hong Mei Community Health Center

    Shanghai, Shanghai Municipality

  • Kang Jian Community Health Center

    Shanghai, Shanghai Municipality

  • Long Hua Community Health Center

    Shanghai, Shanghai Municipality

  • Nan Jing Xi Road Community Health Center

    Shanghai, Shanghai Municipality

  • Tao Pu Community Health Center

    Shanghai, Shanghai Municipality

  • Tian Lin Community Health Center

    Shanghai, Shanghai Municipality

  • Zhen Ru Community Health Center

    Shanghai, Shanghai Municipality

Other trials in China

About this study

This project developed a combined model of the Shanghai Integration Model and peer support for diabetes self-management education and support. The program was implemented and evaluated in nine Community Health Centers in Shanghai, China.

Note: This registration reflects modifications to a study that was registered in 2018.

Read the detailed description

The development of contemporary diabetes care offers new hope for long and satisfying lives of those with the disease, but also provides increased challenges for integration across the many dimensions of care (varied medications in addition to insulin, specialty services, diet, physical activity, stress management, etc.) and across the many who contribute to care (specialists, primary care providers, nurses, dietitians and patient educators, family members, friends, worksites). The Shanghai Integration Model (SIM) has made great strides to integrating specialty/hospital care with primary/community care. The addition of peer support can enhance patient engagement within that integrated care. Peer support can also integrate care with the daily behaviors and patterns that optimal diabetes management requires and with the family members and others in individuals' daily lives who can support diabetes management.

This project developed a combined model of the Shanghai Integration Model and peer support for diabetes self-management education and support. The program was implemented and evaluated in nine Community Health Centers (CHCs) in Shanghai, China. The program is a collaboration among the Shanghai Sixth People's Hospital, Shanghai Jiao Tong University, the Shanghai Diabetes Institute, the Shanghai Health Bureau, the Shanghai Centers for Disease Control, and, at the University of North Carolina-Chapel Hill, Peers for Progress, widely recognized for its leadership in promoting peer support in health care and prevention.

A planned, stepped wedge design to stagger introduction of the program over subsets of CHCs proved impractical within the realities of those sites. Therefore, the original study protocol was modified in the following ways:

  • Instead of staggering program implementation among 3 cohorts of CHCs, all participating CHCs implemented the program concurrently in a single-arm design.
  • A greater number of participants were enrolled than anticipated.
  • To reduce risk of Type 1 error, the number of secondary endpoints was reduced to those central to diabetes management - glycemia, blood pressure, and lipids, and, in the area of psychosocial factors, depression, diabetes distress, and general quality of life.
  • The original plan called for outcome measures to be collected at baseline, 3 months, 6 months, and 12 months according to the stepped wedge study design. Since the CHCs implemented the program in one cohort, the outcome measures were collected at baseline, 12 months, and 18 months in order to assess the long term benefits given the chronic, progressive nature of diabetes.
Being tested
Peer Support
Keywords
Diabetes, Self-Management, Primary Care, Community Health Center, Peer Support, Group Support, Integrated Care, China, Urban
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer SupportBehavioural

    The intervention involves monthly education/support groups co-led by a CHC doctor / nurse and peer leaders. These meetings will begin with a general discussion about participants' previous month, what they had been doing, any special events etc. Meetings will devote time to identifying goals and specific plans for reaching them, rehearsal and/or discussion of specific behaviors to execute plans and ways in which the group members can be helpful to each other. This will be organized around a Diabetes Action Plan. Peer leaders will also organize activities to promote healthy lifestyles, such as walking groups, to promote informal contacts among peer leaders and participants.

Study groups in NCT03438617
Study groupRoleWhat they receive
Peer Support InterventionExperimental9 CHCs will receive the peer support intervention for the full duration of the study period (12 months). Baseline assessment, 12-month and 18-month evaluation to assess the effectiveness and sustainability of the intervention.
Receives: Behavioral: Peer Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline HbA1c at 12 and 18 months

    HbA1c (%)

    Measured: Baseline, 12 months, 18 months

Secondary outcomes (5)

  1. Change from Baseline Blood Pressure at 12 and 18 months

    SBP and DBP (mmHg)

    Measured: Baseline, 12 months, 18 months

  2. Change from Baseline Blood Lipids at 12 and 18 months

    LDL (mmol/L)

    Measured: Baseline, 12 months, 18 months

  3. Change from Baseline General Quality of Life at 12 and 18 months

    5-item measure of quality of life adapted from the EQ-5D, a standardized instrument for measuring generic health status. The respondents are asked to choose one of the statements which best describes their health status on the surveyed day. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions). A sixth item, the visual analogue scale, was not included.

    Measured: Baseline, 12 months, 18 months

  4. Change from Baseline Diabetes Distress at 12 and 18 months

    4-item measure of diabetes distress adapted from the 17-item Diabetes Distress Scale. The respondents are asked to respond to which degree each of the items has bothered them in the past month on a 6-point scale (1-6), where 1 is not a brother and 6 is very bothersome. Scores are summed and divided by 4 to calculate the mean.

    Measured: Baseline, 12 months, 18 months

  5. Change from Baseline Depression at 12 and 18 months

    8-item Patient Health Questionnaire (PHQ), the PHQ-9 minus the last question on suicidal thoughts. The PHQ is a standard instrument used in primary care settings to screen for the presence and severity of depression. The respondents are asked how often they have been bothered by each of the 8 items in the past 2 weeks on a 4 point scale (0-3), where 0 is "not all" and 3 is "nearly every day". The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.

    Measured: Baseline, 12 months, 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2018
  2. Study start8 Mar 2017
  3. Primary completion11 Feb 2019
  4. Study completion11 Feb 2019

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Original Design: This study uses a stepped wedge design in three successive cohorts. Ten community health centers (CHC) will be randomized to one of three cohorts, 3 CHCs in the first cohort vs. 3 CHCs in the second cohort vs. 4 CHCs in the third cohort. Actual Implementation: The Peer Leader program was designed as an implementation study to assess the feasibility, effectiveness and sustainability of integrating peer support with routine care in CHCs. 10 CHCs were selected in this community-based prospective cohort study according to their having in place the key organizational resources and willingness to collaborate. However, one CHC withdrew due to its administrator's judgement of insufficient staff resources for implementation, resulting in 9 CHCs. A planned, stepped wedge design to stagger introduction of the program over subsets of CHCs proved impractical within the realities of those sites. Finally, 9 CHCs participated in this study as one single interventional group.
Masking
None (open label)
Enrolment
1,284 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03438617
Sponsor's protocol ID
2017-197
Status last verified
Jan 2023
First submitted
24 Jan 2018
Last updated
26 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fisher EB, Boothroyd RI, Coufal MM, Baumann LC, Mbanya JC, Rotheram-Borus MJ, Sanguanprasit B, Tanasugarn C. Peer support for self-management of diabetes improved outcomes in international settings. Health Aff (Millwood). 2012 Jan;31(1):130-9. doi: 10.1377/hlthaff.2011.0914.

    PubMed 22232103

  • Zhong X, Wang Z, Fisher EB, Tanasugarn C. Peer Support for Diabetes Management in Primary Care and Community Settings in Anhui Province, China. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S50-8. doi: 10.1370/afm.1799.

    PubMed 26304972

  • 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.

    PubMed 24781960

Questions about this trial

What is this clinical trial studying?

A study testing Peer Support in people with Type 2 Diabetes Mellitus, run by Shanghai 6th People's Hospital at 10 sites in China.

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 3 inclusion and 1 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: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline HbA1c at 12 and 18 months (time frame: Baseline, 12 months, 18 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 NCT03438617, which also lists 3 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 26 Jan 2023.

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