Impact of Peer Support on Diabetes in China

Sponsor
Zhongda Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02119572
Collaborator
(none)
400
1
2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: peer support
  • Other: usual education lectures
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Primary Purpose:
Supportive Care
Official Title:
Impact of Peer Support on Diabetes in China: a Multi-center, Cluster Randomized Controlled Trial
Anticipated Primary Completion Date :
Dec 1, 2016

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline HbA1c at 6 months,12 months [baselline,6months,12months]

    Secondary Outcome Measures

    1. Change from Baseline blood pressure at 6 months,12 months [baseline,6 months,12months]

    2. Change from Baseline months BMI at 6 months,12 months [baseline,6 months,12months]

    3. Change from Baseline months blood liquids at 6 months,12 months [baseline,6 months,12months]

    4. Change from Baseline months blood glucose at 6 months,12 months [baseline,6 months,12months]

    5. Change from baseline in diabetes self-care activities scales at 6 months,12months [baseline,6 months,12months]

    6. Change from baseline in depression scales at 6 months,12months [baseline,6 months,12months]

    7. Change from baseline in medication adherence scales at 6 months,12months [baseline,6 months,12months]

    8. Change from baseline in quality of life scales at 6 months,12months [baseline,6 months,12months]

    9. Change from baseline in diabetes self-efficacy scales at 6 months,12months [baseline,6 months,12months]

    10. Change from baseline in diabetes knowledge scales at 6 months,12months [baseline,6 months, 12 months]

    11. Change from baseline in positive and negative affectivity at 6 months,12months [baseline, 6 months,12months]

    12. Change from baseline in events of hypoglycemia at 6 months,12months [baseline,6 months,12months]

    13. Change from baseline advanced glycation end products at 6 months,12months [baseline ,6 months,12months]

    14. cost [baseline,6 months,12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Liuhe Nanjing Jiangsu China 210009

    Sponsors and Collaborators

    • Zhongda Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zilin Sun, director of endocrine department, Zhongda Hospital
    ClinicalTrials.gov Identifier:
    NCT02119572
    Other Study ID Numbers:
    • Zhongdaendo1
    First Posted:
    Apr 21, 2014
    Last Update Posted:
    Apr 21, 2014
    Last Verified:
    Apr 1, 2014
    Keywords provided by Zilin Sun, director of endocrine department, Zhongda Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 21, 2014