Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled study of the effectiveness of diabetes mellitus (DM) self-management service in DM patients
Acronym
Study hypothesis
Self management programme with focus on improvement of self efficacy and addressing the psycho-social needs of patients with diabetes mellitus would lead to improved health outcomes including clinical parameters.
Ethics approval
The Joint Chinese University of Hong Kong and New Territory East Cluster Clinical Research Ethics Committee approved on the 31st May 2007 (ref: CREC-2007-136-T)
Study design
Randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetes mellitus
Intervention
Both intervention and control groups received their usual medical follow-ups in their GOPCs. The intervention group underwent the six sessions of weekly course of DM self-management service with emphasis on self efficacy and participatory approach addressing the critical gap between the psycho-social and self management support for diabetes patients.
If a subject fulfilled entrance criteria after being assessed by the investigator, s/he was invited to attend a DM care seminar. The objective and the procedures of the study of DM self-management service, and their rights were explained at the end of the seminar. Those interested received further explanation and a written consent was obtained. The subjects were randomised to study group or control group by simple randomisation. The intervention group attended the six sessions of DM Self-management Service in six weeks (one session per week), each session lasted for 2.5 hours.
The total duration of follow up for both groups was 28 weeks. The intervention group received six sessions of training over six weeks period.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. HbA1c level, assessed during baseline, week 8 and week 28
2. DM self efficacy scale, assessed during baseline, week 8 and week 28
3. Dietary behaviours, assesed at baseline, week 8, week 16 and week 28
4. Exercise level, assesed at baseline, week 8, week 16 and week 28
5. Body mass index (BMI), assesed at baseline, week 8, week 16 and week 28
6. Waist-hip ratio, assesed at baseline, week 8, week 16 and week 28
Secondary outcome measures
1. Improvement in urine albumin creatinine ratio between baselines and week 28
2. Improvement in blood pressure between baselines and week 28
Overall trial start date
01/04/2007
Overall trial end date
30/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients attending general outpatient clinics (GOPC) in Hospital Authority New Territory East Cluster
2. For patients with unstable DM control: HbA1C reaches 8.5 or greater
3. Capable of filling in study diary
4. Capable of giving informed written consent
5. Aged over 18 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/04/2007
Recruitment end date
30/09/2008
Locations
Countries of recruitment
Hong Kong
Trial participating centre
School of Public Health and Primary Care
Shatin
N/A
Hong Kong
Sponsor information
Organisation
Centre for Health Education and Health Promotion (Hong Kong)
Sponsor details
Chinese University of Hong Kong
4th Floor
Lek Yuen Health Centre
Shatin
-
Hong Kong
Sponsor type
Research organisation
Website
Funders
Funder type
University/education
Funder name
Chinese University of Hong Kong (Hong Kong) - Centre for Health Education and Health Promotion
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21693570
Publication citations
-
Results
Lee A, Siu CF, Leung KT, Lau LC, Chan CC, Wong KK, General practice and social service partnership for better clinical outcomes, patient self efficacy and lifestyle behaviours of diabetic care: randomised control trial of a chronic care model., Postgrad Med J, 2011, 87, 1032, 688-693, doi: 10.1136/pgmj.2011.118885.