AzTrials
AzTrials

Type 2 Diabetes Treated With InsulinNCT03437525

Peer Support in Diabetes Management - Insulin Peer Support

A study testing Peer Support in people with Type 2 Diabetes Treated With Insulin, run by Shanghai 6th People's Hospital at 11 sites in China.

Completed

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

Official record
Search all trials

Trial summary

This project will develop a combined model of the Shanghai Integration Model and peer support for diabetes self-management with a special focus on appropriate insulin use. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Treated With Insulin
What is being tested?
Peer Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
11 sitesChina
Study dates
8 Mar 2017to 31 Dec 2018
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
  • Currently using insulin or prescribed insulin but not currently using insulin

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

11 sites in 1 country.

11 sites in 1 country

China11 sites
  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality, 200235

  • An Ting Community Health Center

    Shanghai, Shanghai Municipality

  • Cao He Jing 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 will develop a combined model of the Shanghai Integration Model and peer support for diabetes self-management with a special focus on appropriate insulin use.

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.

The "Insulin Peer Support" project is a sub-project of "Peer Support in Diabetes Care", with special focus on appropriate insulin use in the community, to help overcome barriers in insulin treatment and improve treatment compliance. This project will develop a peer support model for diabetes management in Chinese patients undergoing insulin treatment and evaluate its effectiveness in a randomized controlled trial of 10 CHCs in Shanghai.

The project is a collaboration among the Shanghai Sixth People's Hospital, Shanghai Jiao Tong University, the Shanghai Diabetes Institute,the Shanghai Municipal Commission of Health and Family Planning, 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.

Being tested
Peer Support
Keywords
Diabetes, Self-Management, Primary Care, Community Health Center, Peer Support, Group Support, Integrated Care, Insulin, China, Urban
Medical subject headings
Diabetes Mellitus, Insulin Resistance

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 coaches. 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 coaches will provide education and support for insulin therapy to help reduce barriers around insulin use. Peer coaches will also organize activities to promote healthy lifestyles, such as walking groups, to promote informal contacts among peer supporters and participants.

Study groups in NCT03437525
Study groupRoleWhat they receive
Peer Support InterventionExperimentalThe experimental group will receive the peer support intervention for 12 months.
Receives: Behavioral: Peer Support
ControlNo interventionUsual care

What is being measured

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

  1. Change from Baseline HbA1c at 6 and 12 months

    HbA1c (%)

    Measured: Baseline, 6 months, 12 months

Secondary outcomes (24)
  1. Change from Baseline Fasting Blood Glucose at 6 and 12 months

    FPG (mmol/L)

    Measured: Baseline, 6 months, 12 months

  2. Change from Baseline Blood Pressure at 6 and 12 months

    SBP and DBP (mmHg)

    Measured: Baseline, 6 months, 12 months

  3. Change from Baseline BMI at 6 and 12 months

    Height (cm) and weight (kg)

    Measured: Baseline, 6 months, 12 months

  4. Change from Baseline Blood Lipids at 6 and 12 months

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

    Measured: Baseline, 6 months, 12 months

  5. Change from Baseline Hemoglobin at 6 and 12 months

    Hemoglobin (g/L)

    Measured: Baseline, 6 months, 12 months

  6. Change from Baseline Red Blood Cell Count at 6 and 12 months

    Red blood cell count (10^12/L)

    Measured: Baseline, 6 months, 12 months

  7. Change from Baseline Mean Corpuscular Volume at 6 and 12 months

    Mean Corpuscular Volume (fL)

    Measured: Baseline, 6 months, 12 months

  8. Change from Baseline Mean Corpuscular Hemoglobin at 6 and 12 months

    Mean Corpuscular Hemoglobin (pg)

    Measured: Baseline, 6 months, 12 months

  9. Change from Baseline Liver Functioning at 6 and 12 months

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

    Measured: Baseline, 6 months, 12 months

  10. Change from Baseline Bilirubin at 6 and 12 months

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

    Measured: Baseline, 6 months, 12 months

  11. Change from Baseline Blood Urea at 6 and 12 months

    Blood urea (mmol/L)

    Measured: Baseline, 6 months, 12 months

  12. Change from Baseline Serum Creatinine at 6 and 12 months

    Serum creatinine (µmol/L)

    Measured: Baseline, 6 months, 12 months

  13. Change from Baseline Uric Acid at 6 and 12 months

    Uric acid (µmol/L)

    Measured: Baseline, 6 months, 12 months

  14. Change from Baseline Urine Albumin/Creatinine Ratio at 6 and 12 months

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

    Measured: Baseline, 6 months, 12 months

  15. Change in Insulin Functioning at 6 and 12 months

    Insulin (pmol/L)

    Measured: 6 months, 12 months

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

    C-peptide (nmol/L)

    Measured: 6 months, 12 months

  17. Change from Baseline Diabetes Self Care Behaviors at 6 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, 6 months, 12 months

  18. Change from Baseline Medication Adherence at 6 and 12 months

    Morisky 4-item adherence scale. Four yes/no questions about medication adherence in which yes responses are less favorable. Yes responses are coded as 0, No responses are coded as 1, and scores are summed. A total score of 0 is the lowest level of medication adherence and 4 is the highest level of medication adherence.

    Measured: Baseline, 6 months, 12 months

  19. Change from Baseline General Quality of Life at 6 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, 6 months, 12 months

  20. Change from Baseline Diabetes Quality of Life at 6 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, 6 months, 12 months

  21. Change from Baseline Depression at 6 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, 6 months, 12 months

  22. Change in Community Support for Diabetes at 6 and 12 months

    Novel 9-item questionnaire that assesses the degree to which respondents receive community support (other than family) for their diabetes. Items 1-8 are scored from on a scale of 1-5, where 1 is "not at all" and 5 is "completely". Item 9 asks for the relationship of the person / people to the respondent.

    Measured: 6 months, 12 months

  23. Change in Healthcare Utilization at 6 and 12 months

    Novel 6-item questionnaire that assesses patterns of healthcare and program utilization. Item 1 asks respondents the last time they saw a community health center doctor or nurse for their diabetes. Possible responses are "Within the last 2 weeks", "Within the last month", "Within the last 2 months", "Between 2-4 months ago", and "More than 4 months ago". Items 2-6 ask respondents to recall how many times they accessed healthcare services (peer support, primary care, outpatient hospital care, overnight hospital stays) in the past 3 months. Possible responses are "0", "1-2", "3-5", and "5+".

    Measured: 6 months, 12 months

  24. Change from Baseline Insulin Attitudes at 6 and 12 months

    13-item Chinese Attitudes to Starting Insulin Questionnaire (Ch-ASIQ). Four subscales consisting of 'Self-image and stigmatization' (3 items); 'Factors promoting self-efficacy (5 items); 'Fear of pain or needles' (3 items); and 'Time and family support' (2 items). Responses are scored using a 4-point Likert scale (Totally disagree = 1, Totally Agree = 4). Individual scale scores are calculated by summing the item responses. For the subscales 'Factors promoting self-efficacy' and 'Time and family support', higher scores indicate more positive attitudes towards the use of insulin. For the subscales 'Self-image and stigmatization' and 'Fear of pain or needles' a higher score indicates a more negative attitude towards insulin initiation. The weighted sum of all four scale scores, converting two positively coded scales to negatively coded scales, calculates the overall score with higher scores indicating more negative attitude to starting insulin.

    Measured: Baseline, 6 months, 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 posted19 Feb 2018
  2. Study start8 Mar 2017
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

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
Randomised
Intervention model
Parallel groups
Model description
This study uses a cluster randomized controlled trial design with one experimental condition and one control condition. Ten community health centers (CHC) will be randomized to either the experimental or control condition. The five CHCs in the experimental group will deliver the peer support intervention for 12 months and the five CHCs in the control group will deliver usual care.
Masking
None (open label)
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03437525
Sponsor's protocol ID
2017-73
Status last verified
May 2019
First submitted
24 Jan 2018
Last updated
22 May 2019
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 Treated With Insulin, run by Shanghai 6th People's Hospital at 11 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 4 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 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 6 and 12 months (time frame: Baseline, 6 months, 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 NCT03437525, 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 22 May 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in