Plain English Summary
Background and study aims?
Support of patient self-management is a key component of effective diabetes care and improved patient outcomes. A series of peer-led community-based disease-specific self-management programs including diabetes have been developed, tested and disseminated in Shanghai in the last ten years. However, the strategy of using trained lay leaders to support patient self-management faced challenges in rural communities in Shanghai. The aim of this study is to develop a Chinese diabetes group visit program as an alternative approach to support patient self-management and to examine its effectiveness on self-management behaviors, self-efficacy and health status for patients in rural communities of Shanghai.
Who can participate?
This study aims to recruit about 200 community-dwelling patients with type 2 diabetes from two rural communities in Shanghai, China.
What does the study involve?
Two groups will be created. One group will receive 12 monthly group visit sessions. Each session consists of 1.5-hour group self-management education and 1-hour one-on-one visits with health care providers. The group self-management education sessions will focus on helping participants build confidence in their ability to deal with diabetes by incorporating self-efficacy enhancing strategies, including monthly action planning and feedback, modelling of behaviors by participants for one another, reinterpretation of symptoms, practicing self-management skills, and group problem-solving. The other group will receive usual care.
At the end of the study, we will compare changes in self-management behaviors (diet, aero exercise, practice of cognitive symptom management, communication with doctor, and examining feet); self-efficacy to manage diabetes in general; and health status (self-rated health, energy, health distress, level of fatigue, illness intrusiveness, depression, body mass index, systolic and diastolic blood pressure levels) between the two groups.
What are the possible benefits and risks of participating?
Participants who are randomly allocated to the intervention group will receive an additional 12 monthly diabetes group visit sessions helping them improve their confidence, skills and knowledge to self-manage their type 2 diabetes.
By taking part in this study there are no risks of physical or psychological injury or harm.
Where is the study run from?
The study is conducted by Songjiang District Center for Disease Prevention and Control in collaboration with Fudan University.
When is the study starting and how long is it expected to run for?
The study started in January 2007 to recruit participants and ended by June 2008.
Who is funding the study?
The Initiative for Cardiovascular Health Research in Developing Countries (IC-HEALTH) (ref: ICH/DIA/PDG/O6/03) and Songjiang District Center for Disease Prevention and Control, Shanghai, China .
Who is the main contact?
Dr Shengsheng Liu
cdclss@sohu.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Shengsheng Liu
ORCID ID
Contact details
1050 North Xi Lin Road
Shanghai
201620
China
cdclss@sohu.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A group visit model to support diabetes patients self-management in rural communities of Shanghai: a randomized trial
Acronym
Study hypothesis
A group visit model offering patients routine primary care in combination with group support and self-management education will improve self-management behavior, self-efficacy to manage diabetes and health status indicators for patients with type 2 diabetes in rural communities of Shanghai.
Ethics approval
School of Public Health Ethics Committee, Fudan University, 02 December 2006, ref: 06-021
Study design
One year randomized single blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type 2 diabetes
Intervention
The intervention group will receive 12 monthly diabetes group visit sessions. Each session consists of a 1.5-hour self-management group education and 1 hour one-on-one visits with health care providers. The control group will only receive usual care.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Change in self-management behavior scores (diet, aero exercise, practice of cognitive symptom management, communication with doctor, and examining feet)
2. Change in self-efficacy score (self-efficacy to manage diabetes in general)
3. Change in health status indicators (self-rated health, energy, health distress, level of fatigue, illness intrusiveness, depression, body mass index, systolic and diastolic blood pressure levels)
With the exception of the questions about diet, examining feet, body mass index (BMI), and blood pressure levels, which were developed for this study, all measures had been previously validated.
Secondary outcome measures
Baseline scores for self-management behaviors and self-efficacy to manage diabetes in general and health status
Overall trial start date
01/01/2007
Overall trial end date
30/06/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Men and women aged 35-80 with type 2 diabetes confirmed by medical records
2. Community dwelling
3. Willing to be assigned to any of the study groups
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Patients aged less than 35 years or more than 80 years
2. Patients with mental illness or stroke
3. Patients with severe physical disability that would prevent attendance or participation in the groups
Recruitment start date
01/01/2007
Recruitment end date
30/06/2008
Locations
Countries of recruitment
China
Trial participating centre
1050 North Xi Lin Road
Shanghai
201620
China
Sponsor information
Organisation
Fudan University (China)
Sponsor details
School of Public Health
138 Yi Xue Yuan Road
Shanghai
200032
China
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Initiative for Cardiovascular Health Research in Developing Countries (India) ref: ICH/DIA/PDG/O6/03
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Songjiang District Center for Disease Prevention and Control (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23198694
Publication citations
-
Results
Liu S, Bi A, Fu D, Fu H, Luo W, Ma X, Zhuang L, Effectiveness of using group visit model to support diabetes patient self-management in rural communities of Shanghai: a randomized controlled trial., BMC Public Health, 2012, 12, 1043, doi: 10.1186/1471-2458-12-1043.