Peer Support in Diabetes Management - Insulin Peer Support

May 20, 2019 updated by: Weiping Jia, Shanghai 6th People's Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200235
        • Shanghai Sixth People's Hospital
      • Shanghai, Shanghai, China
        • An Ting Community Health Center
      • Shanghai, Shanghai, China
        • Cao He Jing Community Health Center
      • Shanghai, Shanghai, China
        • Cao Yang Community Health Center
      • Shanghai, Shanghai, China
        • Hong Mei Community Health Center
      • Shanghai, Shanghai, China
        • Kang Jian Community Health Center
      • Shanghai, Shanghai, China
        • Long Hua Community Health Center
      • Shanghai, Shanghai, China
        • Nan Jing Xi Road Community Health Center
      • Shanghai, Shanghai, China
        • Tao Pu Community Health Center
      • Shanghai, Shanghai, China
        • Tian Lin Community Health Center
      • Shanghai, Shanghai, China
        • Zhen Ru Community Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chinese
  • Has type 2 diabetes
  • Receiving treatment at participating community health center
  • Currently using insulin or prescribed insulin but not currently using insulin

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Usual care
Experimental: Peer Support Intervention
The experimental group will receive the peer support intervention for 12 months.
Behavioral: Peer Support
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline HbA1c at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
HbA1c (%)
Baseline, 6 months, 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Hemoglobin at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
Hemoglobin (g/L)
Baseline, 6 months, 12 months
Change from Baseline Red Blood Cell Count at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
Red blood cell count (10^12/L)
Baseline, 6 months, 12 months
Change from Baseline Mean Corpuscular Volume at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
Mean Corpuscular Volume (fL)
Baseline, 6 months, 12 months
Change from Baseline Mean Corpuscular Hemoglobin at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
Mean Corpuscular Hemoglobin (pg)
Baseline, 6 months, 12 months
Change from Baseline Liver Functioning at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
ALT (U/L), AST (U/L), Alkaline phosphatase (U/L), r-GT (U/L)
Baseline, 6 months, 12 months
Change from Baseline Bilirubin at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
Total bilirubin (µmol/L), Direct bilirubin (µmol/L)
Baseline, 6 months, 12 months
Change from Baseline Blood Urea at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
Blood urea (mmol/L)
Baseline, 6 months, 12 months
Change from Baseline Serum Creatinine at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
Serum creatinine (µmol/L)
Baseline, 6 months, 12 months
Change from Baseline Uric Acid at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
Uric acid (µmol/L)
Baseline, 6 months, 12 months
Change from Baseline Urine Albumin/Creatinine Ratio at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
Albumin (mg/L), Creatinine (mmol/L)
Baseline, 6 months, 12 months
Change from Baseline Fasting Blood Glucose at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
FPG (mmol/L)
Baseline, 6 months, 12 months
Change from Baseline Blood Pressure at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
SBP and DBP (mmHg)
Baseline, 6 months, 12 months
Change from Baseline BMI at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
Height (cm) and weight (kg)
Baseline, 6 months, 12 months
Change from Baseline Blood Lipids at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
Total cholesterol, triglycerides, HDL, LDL (mmol/L)
Baseline, 6 months, 12 months
Change in Insulin Functioning at 6 and 12 months
Time Frame: 6 months, 12 months
Insulin (pmol/L)
6 months, 12 months
Change in C-peptides at 6 and 12 months
Time Frame: 6 months, 12 months
C-peptide (nmol/L)
6 months, 12 months
Change from Baseline Diabetes Self Care Behaviors at 6 and 12 months
Time Frame: Baseline, 6 months, 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.
Baseline, 6 months, 12 months
Change from Baseline Medication Adherence at 6 and 12 months
Time Frame: Baseline, 6 months, 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.
Baseline, 6 months, 12 months
Change from Baseline General Quality of Life at 6 and 12 months
Time Frame: Baseline, 6 months, 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"
Baseline, 6 months, 12 months
Change from Baseline Diabetes Quality of Life at 6 and 12 months
Time Frame: Baseline, 6 months, 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.
Baseline, 6 months, 12 months
Change from Baseline Depression at 6 and 12 months
Time Frame: Baseline, 6 months, 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.
Baseline, 6 months, 12 months
Change in Community Support for Diabetes at 6 and 12 months
Time Frame: 6 months, 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.
6 months, 12 months
Change in Healthcare Utilization at 6 and 12 months
Time Frame: 6 months, 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+".
6 months, 12 months
Change from Baseline Insulin Attitudes at 6 and 12 months
Time Frame: Baseline, 6 months, 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.
Baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai 6th People's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of North Carolina, Chapel Hill
Asian Center for Health Education
Shanghai Municipal Commission of Health and Family Planning
Sanofi China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Weiping Jia, MD, PhD, Shanghai 6th People's Hospital
  • Principal Investigator: Edwin B Fisher, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Treated With Insulin

Clinical Trials on Peer Support

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings