NCT02119572

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

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

First QC Date

April 15, 2014

Last Update Submit

April 18, 2014

Conditions

Glucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesDiabetes

Keywords

diabetes,peer support

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline HbA1c at 6 months,12 months

    baselline,6months,12months

Secondary Outcomes (14)

  • Change from Baseline blood pressure at 6 months,12 months

    baseline,6 months,12months

  • Change from Baseline months BMI at 6 months,12 months

    baseline,6 months,12months

  • Change from Baseline months blood liquids at 6 months,12 months

    baseline,6 months,12months

  • Change from Baseline months blood glucose at 6 months,12 months

    baseline,6 months,12months

  • Change from baseline in diabetes self-care activities scales at 6 months,12months

    baseline,6 months,12months

  • +9 more secondary outcomes

Study Arms (2)

peer support

EXPERIMENTAL

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 supportOther: usual education lectures

usual education

ACTIVE COMPARATOR

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

Interventions

peer supportBEHAVIORAL
Also known as: peer education, peer coach
peer support
usual education lecturesOTHER
peer supportusual education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liuhe

Nanjing, Jiangsu, 210009, China

RECRUITING

Related Publications (2)

  • Ju C, Shi R, Yao L, Ye X, Jia M, Han J, Yang T, Lu Q, Jin H, Cai X, Yuan S, Xie B, Yu X, Coufal MM, Fisher EB, Sun Z. Effect of peer support on diabetes distress: a cluster randomized controlled trial. Diabet Med. 2018 Jun;35(6):770-775. doi: 10.1111/dme.13625. Epub 2018 Apr 11.

    PMID: 29574995DERIVED

  • Xie B, Ye XL, Sun ZL, Jia M, Jin H, Ju CP, Yao L, De Vladmir CH, Yang Y. Peer support for patients with type 2 diabetes in rural communities of China: protocol for a cluster randomized controlled trial. BMC Public Health. 2014 Jul 23;14:747. doi: 10.1186/1471-2458-14-747.

    PMID: 25056813DERIVED

MeSH Terms

Conditions

Glucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Zilin Sun, Dr.

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Xie, MPH

CONTACT

86-25-83272526boxxie80@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of endocrine department

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 21, 2014

Primary Completion

December 1, 2016

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations

CN(1)