A group visit model to support diabetes patients’ self-management in rural communities of Shanghai

ISRCTN ISRCTN87909028
DOI https://doi.org/10.1186/ISRCTN87909028
Secondary identifying numbers N/A
Submission date
26/05/2012
Registration date
07/06/2012
Last edited
11/12/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Shengsheng Liu
Scientific

1050 North Xi Lin Road
Shanghai
201620
China

Email cdclss@sohu.com

Study information

Study designOne year randomized single blinded trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA group visit model to support diabetes patients’ self-management in rural communities of Shanghai: a randomized trial
Study objectivesA 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(s)School of Public Health Ethics Committee, Fudan University, 02 December 2006, ref: 06-021
Health condition(s) or problem(s) studiedType 2 diabetes
InterventionThe 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 typeOther
Primary outcome measure1. 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 measuresBaseline scores for self-management behaviors and self-efficacy to manage diabetes in general and health status
Overall study start date01/01/2007
Completion date30/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants200
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2007
Date of final enrolment30/06/2008

Locations

Countries of recruitment

  • China

Study participating centre

1050 North Xi Lin Road
Shanghai
201620
China

Sponsor information

Fudan University (China)
University/education

School of Public Health
138 Yi Xue Yuan Road
Shanghai
200032
China

Website http://sph.fudan.edu.cn/
ROR logo "ROR" https://ror.org/013q1eq08

Funders

Funder type

Research organisation

Initiative for Cardiovascular Health Research in Developing Countries (India) ref: ICH/DIA/PDG/O6/03

No information available

Songjiang District Center for Disease Prevention and Control (China)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 03/12/2012 Yes No