Effectiveness of diabetes mellitus self management programme

ISRCTN	ISRCTN78882965
DOI	https://doi.org/10.1186/ISRCTN78882965
Protocol serial number	N/A
Sponsor	Centre for Health Education and Health Promotion (Hong Kong)
Funder	Chinese University of Hong Kong (Hong Kong) - Centre for Health Education and Health Promotion

Submission date: 23/07/2010
Registration date: 25/08/2010
Last edited: 10/01/2012

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

Not provided at time of registration

Contact information

Prof Albert Lee
Scientific

School of Public Health and Primary Care
The Chinese University of Hong Kong
4th Floor, School of Public Health
Shatin
N/A
Hong Kong

Study information

Primary study design	Interventional
Study design	Randomised controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled study of the effectiveness of diabetes mellitus (DM) self-management service in DM patients
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	1. Improvement in urine albumin creatinine ratio between baselines and week 28 2. Improvement in blood pressure between baselines and week 28
Completion date	30/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2007
Date of final enrolment	30/09/2008

Locations

Countries of recruitment

Hong Kong

Study participating centre

School of Public Health and Primary Care

Shatin
N/A
Hong Kong

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes