Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/07/2010
Date assigned
25/08/2010
Last edited
10/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Albert Lee

ORCID ID

Contact details

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

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 measures

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

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

http://www.cuhk.edu.hk/med/prof_lee/main.html

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21693570

Publication citations

  1. 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.

Additional files

Editorial Notes