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Type2 DiabetesNCT03958838

Peer Support To Enhance The Shanghai Integration Model Of Diabetes Care: Dissemination To 12 Communities

A study testing Peer Support Integrated with Primary Care in people with Type2 Diabetes and PreDiabetes, run by Shanghai 6th People's Hospital at 16 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 will disseminate a community-level intervention that integrates peer support from Community Self-Management Groups (CSMGs) and primary care through Community Health Centers (CHC). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Type2 Diabetes, PreDiabetes
What is being tested?
Peer Support Integrated with Primary Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,160 participants
Where
16 sitesChina
Study dates
30 Mar 2019to 3 Nov 2021
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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults age ≥ 18
  • Chinese
  • Has type 2 diabetes or prediabetes
  • Patient at participating CHC
  • Intervention group: 120 subjects at each of 12 CHCs
  • ~40 patients (Pre-diabetes including IFG or IGT)
Show all 17Show fewer
  • ~40 patients (Diabetics with poor control, FPG≥9.7 mmol/L)
  • ~40 patients (Newly-diagnosed diabetics within 2 years)
  • Control group: 240 control subjects at each of 2 CHCs (Yichuan and Zhaoxiang) and 120 control subjects at each of 2 CHCs (Xuhang and Waigang)
  • o (Yichuan and Zhaoxiang)
  • ~80 patients (Pre-diabetes including IFG or IGT)
  • ~80 patients (Diabetics with poor control, FPG≥9.7 mmol/L)
  • ~80 patients (Newly-diagnosed diabetics within 2 years)
  • o (Xuhang and Waigang)
  • ~40 patients (Pre-diabetes including IFG or IGT)
  • ~40 patients (Diabetics with poor control, FPG≥9.7 mmol/L)
  • ~40 patients Newly-diagnosed diabetics within 2 years)

Who cannot join

  • No serious mental illness (i.e. major depression, schizophrenia, bipolar disorder, obsessive compulsive disorder, panic disorder, post-traumatic stress disorder, borderline personality disorder)
  • Withdrawal criteria:
  • No longer a patient at participating CHC (moved, deceased, extended hospitalization)

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • Anting Huangdu Community Health Center

    Shanghai, Shanghai Municipality

  • Baihe Community Health Center

    Shanghai, Shanghai Municipality

  • Dachang Qilian Community Health Center

    Shanghai, Shanghai Municipality

  • Fangsong Community Health Center

    Shanghai, Shanghai Municipality

  • Guangzhong Community Health Center

    Shanghai, Shanghai Municipality

  • Huamu Community Health Center

    Shanghai, Shanghai Municipality

  • Liantang Community Health Center

    Shanghai, Shanghai Municipality

  • Luodian Community Health Center

    Shanghai, Shanghai Municipality

  • Nanxiang Community Health Center

    Shanghai, Shanghai Municipality

  • Nicheng Community Health Center

    Shanghai, Shanghai Municipality

  • Ouyang Community Health Center

    Shanghai, Shanghai Municipality

  • Waigang Community Health Center

    Shanghai, Shanghai Municipality

  • Xiao Kunshan Community Health Center

    Shanghai, Shanghai Municipality

  • Xuhang Community Health Center

    Shanghai, Shanghai Municipality

  • Yichuan Community Health Center

    Shanghai, Shanghai Municipality

  • Zhaoxiang Community Health Center

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: Peer Support to Enhance the Shanghai Integration Model of Diabetes Care: Dissemination to 12 Communities

This project will disseminate a community-level intervention that integrates peer support from Community Self-Management Groups (CSMGs) and primary care through Community Health Centers (CHC). The model and program materials were developed and refined from the first year of implementation within community health centers in Shanghai. This project will be implemented in 12 communities in 6 districts across Shanghai, representing a diverse cross section of the population. A total of 1440 subjects will be recruited from the 12 intervention communities and 720 control subjects will be recruited from 4 control communities.

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 will disseminate a community-level intervention that integrates peer support from Community Self-Management Groups (CSMGs) and primary care through Community Health Centers (CHC). The model and program materials were developed and refined from the first year of implementation within community health centers in Shanghai. This project will be implemented in 12 communities in 6 districts across Shanghai, representing a diverse cross section of the population. A total of 1440 subjects will be recruited from the 12 intervention communities and 720 control subjects will be recruited from 4 control communities.

The program is a collaboration among the Shanghai Sixth People's Hospital, Shanghai Jiao Tong University, the Shanghai Diabetes Institute, the National Office for Primary Diabetes Care, the Shanghai Municipal Health Commission, the Shanghai Municipal Center for Disease Control and Prevention, 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.

Collaborators:

Shanghai Sixth People's Hospital Shanghai Jiao Tong University Shanghai Diabetes Institute National Office for Primary Diabetes Care Shanghai Municipal Health Commission Shanghai Municipal Center for Disease Control and Prevention University of North Carolina at Chapel Hill, Peers for Progress

Being tested
Peer Support Integrated with Primary Care
Keywords
Peer Support, Social Support, Primary Care, Integrated Care, Community-Based, Self-Management, Diabetes Care
Medical subject headings
Prediabetic State

What participants receive

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

  • Peer Support Integrated with Primary CareBehavioural

    Peer leaders will deliver support that address the four key functions of peer support, providing 1) assistance in daily self-management, 2) linkages to clinical care and community resources, 3) social and emotional support, and 4) ongoing, flexible support over time.

Study groups in NCT03958838
Study groupRoleWhat they receive
Intervention GroupExperimentalSubjects will receive usual care from community health center staff. In addition, they will also receive a variety of community-level and individual-level interventions, categorized broadly into three levels. At the community level, subjects will receive the 5 Key Diabetes Messages that Everyone Should Know and the 6 Modules of Basic Diabetes Education. At the individual level, subjects and their families will be invited to participate in group activities, co-organized by community health staff, CHC staff, and CSMG peer leaders. Subjects will receive in-person peer support through these group activities, with follow up through telephone calls and text messaging. For subjects that have poorly controlled diabetes or are experiencing emotional distress related to their diabetes, CSMG peer leaders will work closely with them to help them solve problems around their diabetes.
Receives: Behavioral: Peer Support Integrated with Primary Care
Control GroupNo interventionSubjects in the control group will receive usual care from community health center staff.

What is being measured

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

  1. Change from Baseline HbA1c and at 12 months

    HbA1c (%)

    Measured: Baseline, 12 months

Secondary outcomes (25)

  1. Change from Baseline Fasting Blood Glucose and at 12 months

    FPG (mmol/L)

    Measured: Baseline, 12 months

  2. Change from Baseline Blood Pressure and at 12 months

    SBP and DBP (mmHg)

    Measured: Baseline, 12 months

  3. Change from Baseline BMI and at 12 months

    Height (cm) and weight (kg)

    Measured: Baseline, 12 months

  4. Change from Baseline Blood Lipids and at 12 months

    Total cholesterol, triglycerides, HDL, LDL (mmol/L)

    Measured: Baseline, 12 months

  5. Change from Baseline Waist circumference and at 12 months

    Waist circumference (cm)

    Measured: Baseline, 12 months

  6. Change from Baseline Hemoglobin and at 12 months

    Hemoglobin (g/L)

    Measured: Baseline, 12 months

  7. Change from Baseline Red Blood Cell Count and at 12 months

    Red blood cell count (10^12/L)

    Measured: Baseline, 12 months

  8. Change from Baseline Mean Corpuscular Volume and at 12 months

    Mean Corpuscular Volume (fL)

    Measured: Baseline, 12 months

  9. Change from Baseline Mean Corpuscular Hemoglobin and at 12 months

    Mean Corpuscular Hemoglobin (pg)

    Measured: Baseline, 12 months

  10. Change from Baseline Liver Functioning and at 12 months

    ALT (U/L), AST (U/L), Alkaline phosphatase (U/L), r-GT (U/L)

    Measured: Baseline, 12 months

  11. Change from Baseline Bilirubin and at 12 months

    Total bilirubin (μmol/L), Direct bilirubin (μmol/L)

    Measured: Baseline, 12 months

  12. Change from Baseline Blood Urea and at 12 months

    Blood urea (mmol/L)

    Measured: Baseline, 12 months

  13. Change from Baseline Serum Creatinine and at 12 months

    Serum creatinine (μmol/L)

    Measured: Baseline, 12 months

  14. Change from Baseline Uric Acid and at 12 months

    Uric acid (μmol/L)

    Measured: Baseline, 12 months

  15. Change from Baseline Urine Albumin/Creatinine Ratio and at 12 months

    Albumin (mg/L), Creatinine (mmol/L)

    Measured: Baseline, 12 months

  16. Change in Insulin Functioning at 6 and 12 months

    Insulin (pmol/L)

    Measured: Baseline, 12 months

  17. Change in C-peptides at 6 and 12 months

    C-peptide (nmol/L)

    Measured: Baseline, 12 months

  18. Change in CRP at 6 and 12 months

    CRP (mg/dL）

    Measured: Baseline, 12 months

  19. Change from Baseline Diabetes Self Care Behaviors and 12 months

    9 items from Summary of Diabetes Self Care Activities and Behavioral Risk Factor Surveillance System. Items 1-7 measure diabetes self care activities during the previous 7 days. Items 1, 2, 4-7 are assessed on a scale of 0 to 7 days. Item 3 is assessed on scale of 1-4, where 1 represents very low levels of daily activity and 4 represents very high levels of daily activity. Items 8 and 9 are yes/no questions that measure cigarette intake over the past 7 and 30 days.

    Measured: Baseline, 12 months

  20. Change from Baseline General Quality of Life and 12 months

    6-item 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). Item 6 is the visual analogue scale, in which respondents are asked to mark their health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100, where 0 corresponds to "the worst health you can imagine", and 100 corresponds to "the best health you can imagine"

    Measured: Baseline, 12 months

  21. Change from Baseline Diabetes Quality of Life and 12 months

    4-item Diabetes Distress Scale, an abbreviated version of 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. Mean scores of 3 or higher (moderate distress) are considered worthy of clinical attention.

    Measured: Baseline, 12 months

  22. Change from Baseline Depression and 12 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

  23. Change from Baseline Insulin Attitudes and 12 months

    ITAS items, 6 questions

    Measured: Baseline, 12 months

  24. Change in Neighborhood Interactions and 12 months

    6 questions

    Measured: Baseline, 12 months

  25. Change in Peer Support Engagement and Health Care Utilization and 12 months

    5 questions

    Measured: Baseline, 12 months

Timeline

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

  1. First posted22 May 2019
  2. Study start30 Mar 2019
  3. Primary completion3 Nov 2021
  4. Study completion3 Nov 2021

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
Non-randomised
Intervention model
Parallel groups
Model description
Intervention group and Control group
Masking
None (open label)
Enrolment
2,160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03958838
Sponsor's protocol ID
2019-028
Status last verified
Dec 2024
First submitted
20 May 2019
Last updated
16 Dec 2024
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

  • Evans M, Liu Y, Wu X, Cai C, Tang PY, Maggy Coufal M, Qian Y, Fisher EB, Jia W. Community organization guides standardization, adaptability, and innovation: lessons from peer support in the Shanghai Integration Model. Transl Behav Med. 2023 Aug 11;13(8):519-532. doi: 10.1093/tbm/ibac094.

    PubMed 37406180

Questions about this trial

What is this clinical trial studying?

A study testing Peer Support Integrated with Primary Care in people with Type2 Diabetes and PreDiabetes, run by Shanghai 6th People's Hospital at 16 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 17 inclusion and 3 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 and at 12 months (time frame: Baseline, 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 NCT03958838, which also lists 4 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 16 Dec 2024.

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