Impact of Peer Support on Diabetes in China

April 18, 2014 updated by: Zilin Sun, Zhongda Hospital

Impact of Peer Support on Diabetes in China: a Multi-center, Cluster Randomized Controlled Trial

The prevalence of diabetes has been growing rapidly in developing countries causing a devastating economic burden and increasing demands on healthcare systems. Therefore, there is an urgent need to find cost-effective and multi-faceted approach for diabetes care. Peer support models provide a potentially low-cost, flexible means that is complimentary to the current existing health care services. Trained peer leaders can become qualified extenders to a formal healthcare system, thereby, assisting with the education delivery and bolstering the efforts of the professional staff. To implement a culturally- specific peer support program and determine whether it is acceptable, cost-effective in China is important. This study aims to implement and evaluate biophysical and psychosocial outcomes of a peer support program and to explore it's feasibility and sustainability in China

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • 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
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Liuhe
        • Contact:
        • Principal Investigator:
          • Zilin Sun, Dr.

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. type 2 diabetes
  2. with voluntary participation and have signed the Patient Informed Consent Sheet
  3. reside in stable places during the intervention period

Exclusion Criteria:

  1. Patients with reduced life expectancy and unstable mood or major psychiatric conditions
  2. suffering from cancer and have been receiving radiotherapy and/ or chemotherapy in the past half year
  3. enrolling in other research program at present

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: peer support
Patients are divided into small groups and assigned with peer leaders for twelve months according to their residence. Besides the same training and follow-ups as the control arm, patients from intervention groups are suggested and encouraged to take part in the group activities with the peer leaders per month. And if possible, casual activities (such as phone call, chatting, short message; physical exercise, group member family visiting，going to supermarket together, etc.)are also recommended
Behavioral: peer support
Other Names:
  • peer education, peer coach
Other: usual education lectures
Active Comparator: usual education
Patients attend the usual self-management education and communicate with the professionals every two months, getting the information on diabetes diet, exercise, glucose monitor, etc. besides that the group members should attend three follow ups at baseline,6 and 12 months.
Other: usual education lectures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline HbA1c at 6 months,12 months
Time Frame: baselline,6months,12months
baselline,6months,12months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline blood pressure at 6 months,12 months
Time Frame: baseline,6 months,12months
baseline,6 months,12months
Change from Baseline months BMI at 6 months,12 months
Time Frame: baseline,6 months,12months
baseline,6 months,12months
Change from Baseline months blood liquids at 6 months,12 months
Time Frame: baseline,6 months,12months
baseline,6 months,12months
Change from Baseline months blood glucose at 6 months,12 months
Time Frame: baseline,6 months,12months
baseline,6 months,12months
Change from baseline in diabetes self-care activities scales at 6 months,12months
Time Frame: baseline,6 months,12months
baseline,6 months,12months
Change from baseline in depression scales at 6 months,12months
Time Frame: baseline,6 months,12months
baseline,6 months,12months
Change from baseline in medication adherence scales at 6 months,12months
Time Frame: baseline,6 months,12months
baseline,6 months,12months
Change from baseline in quality of life scales at 6 months,12months
Time Frame: baseline,6 months,12months
baseline,6 months,12months
Change from baseline in diabetes self-efficacy scales at 6 months,12months
Time Frame: baseline,6 months,12months
baseline,6 months,12months
Change from baseline in diabetes knowledge scales at 6 months,12months
Time Frame: baseline,6 months, 12 months
baseline,6 months, 12 months
Change from baseline in positive and negative affectivity at 6 months,12months
Time Frame: baseline, 6 months,12months
baseline, 6 months,12months
Change from baseline in events of hypoglycemia at 6 months,12months
Time Frame: baseline,6 months,12months
baseline,6 months,12months
Change from baseline advanced glycation end products at 6 months,12months
Time Frame: baseline ,6 months,12months
baseline ,6 months,12months
cost
Time Frame: baseline,6 months,12 months
baseline,6 months,12 months

Collaborators and Investigators

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

Sponsor

Zhongda Hospital

Investigators

  • Principal Investigator: Zilin Sun, Dr., Zhongda Hospital

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

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

April 18, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 18, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zhongdaendo1

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.

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