Effectiveness of diabetes mellitus self management programme
| ISRCTN | ISRCTN78882965 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78882965 |
| Secondary identifying numbers | N/A |
- 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
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
| Study design | Randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/04/2007 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
N/A
Hong Kong
Sponsor information
Centre for Health Education and Health Promotion (Hong Kong)
Research organisation
Research organisation
Chinese University of Hong Kong
4th Floor
Lek Yuen Health Centre
Shatin
-
Hong Kong
| Website | http://www.cuhk.edu.hk/med/prof_lee/main.html |
|---|---|
"ROR" |
https://ror.org/00t33hh48 |
Funders
Funder type
University/education
Chinese University of Hong Kong (Hong Kong) - Centre for Health Education and Health Promotion
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
