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Impact of Peer Support on Diabetes in China

Primary Purpose

Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
peer support
usual education lectures
Sponsored by
Zhongda Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glucose Metabolism Disorders focused on measuring diabetes,peer support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LiuheRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

peer support

usual education

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change from Baseline HbA1c at 6 months,12 months

Secondary Outcome Measures

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

Full Information

First Posted
April 15, 2014
Last Updated
April 18, 2014
Sponsor
Zhongda Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02119572
Brief Title
Impact of Peer Support on Diabetes in China
Official Title
Impact of Peer Support on Diabetes in China: a Multi-center, Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongda Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Diabetes
Keywords
diabetes,peer support

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
peer support
Arm Type
Experimental
Arm Description
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
Arm Title
usual education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
peer support
Other Intervention Name(s)
peer education, peer coach
Intervention Type
Other
Intervention Name(s)
usual education lectures
Primary Outcome Measure Information:
Title
Change from Baseline HbA1c at 6 months,12 months
Time Frame
baselline,6months,12months
Secondary Outcome Measure Information:
Title
Change from Baseline blood pressure at 6 months,12 months
Time Frame
baseline,6 months,12months
Title
Change from Baseline months BMI at 6 months,12 months
Time Frame
baseline,6 months,12months
Title
Change from Baseline months blood liquids at 6 months,12 months
Time Frame
baseline,6 months,12months
Title
Change from Baseline months blood glucose at 6 months,12 months
Time Frame
baseline,6 months,12months
Title
Change from baseline in diabetes self-care activities scales at 6 months,12months
Time Frame
baseline,6 months,12months
Title
Change from baseline in depression scales at 6 months,12months
Time Frame
baseline,6 months,12months
Title
Change from baseline in medication adherence scales at 6 months,12months
Time Frame
baseline,6 months,12months
Title
Change from baseline in quality of life scales at 6 months,12months
Time Frame
baseline,6 months,12months
Title
Change from baseline in diabetes self-efficacy scales at 6 months,12months
Time Frame
baseline,6 months,12months
Title
Change from baseline in diabetes knowledge scales at 6 months,12months
Time Frame
baseline,6 months, 12 months
Title
Change from baseline in positive and negative affectivity at 6 months,12months
Time Frame
baseline, 6 months,12months
Title
Change from baseline in events of hypoglycemia at 6 months,12months
Time Frame
baseline,6 months,12months
Title
Change from baseline advanced glycation end products at 6 months,12months
Time Frame
baseline ,6 months,12months
Title
cost
Time Frame
baseline,6 months,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: type 2 diabetes with voluntary participation and have signed the Patient Informed Consent Sheet reside in stable places during the intervention period Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Xie, MPH
Phone
86-25-83272526
Email
boxxie80@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zilin Sun, Dr.
Organizational Affiliation
Zhongda Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liuhe
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiu li Ye, Master
Phone
86-25-83272532
Email
yexiuli0703@163.com
First Name & Middle Initial & Last Name & Degree
Zilin Sun, Dr.

12. IPD Sharing Statement

Citations:
PubMed Identifier
29574995
Citation
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.
Results Reference
derived
PubMed Identifier
25056813
Citation
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.
Results Reference
derived

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Impact of Peer Support on Diabetes in China

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