Effectiveness of Pre-medical Consultation Diabetes Self-care Education Programme on Glycemic Control in Type 2 Diabetes (PMC-SEP)
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|ClinicalTrials.gov Identifier: NCT04092569|
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Behavioral: Pre-medical consultation structured diabetes self-care education programme||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
All patients who are 'newly referred for advanced diabetes management' from general practitioners or general out-patient clinic to specialist out-patient clinic of Alice Ho Miu Ling Nethersole Hospital from 1/8/2019 to 31/12/2019 will be recruited.
After signing written informed consent on day of diabetes complication screening, they will be randomized into CG (n=10 for pilot study; n=60 for main study) or IG (n=10 for pilot study; n=60 for main study) groups, using sealed envelope, opened by an independent staff, containing randomly generated computer codes for group assignment. All patients will undergo diabetes complication screening including examination of eye and feet, collection of blood and urine samples and filling in DM questionnaires at baseline, and HbA1c with diabetes self-care questionnaires at 24 weeks (for IG only) and 36 weeks.
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||The Effectiveness of Pre-medical Consultation (PMC) Diabetes Self-care Education Programme on Glycemic Control in Adults With Type 2 Diabetes|
|Actual Study Start Date :||September 10, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Active Comparator: Intervention group
Pre-medical consultation structured diabetes self-care education programme
Behavioral: Pre-medical consultation structured diabetes self-care education programme
The findings of integrative review revealed positive effects of DSME in improving glycemic control and promoting self-care among people with type 2 diabetes.
An evidence-based protocol is developed based on these findings to generate a DSME program for newly referred patients to SOPCs and before their first medical consultation to improve glycemic control and enhance self-care of people with type 2 diabetes in Hong Kong. The investigator will ensure that this study is conducted in compliance with ICH-GCP and in compliance with the Declaration of Helsinki.
No Intervention: Control group
- Change from Baseline Blood Glycosylated haemoglobin, HbA1c at 6 months [ Time Frame: At baseline, week 24. ]Blood HbA1c will be taken at baseline diabetes complication screening, week 24 for both IG and CG.
- Change from Baseline Blood Glycosylated haemoglobin, HbA1c at 9 months [ Time Frame: At baseline, week 36. ]Blood HbA1c will be taken at baseline diabetes complication screening week 36 for both IG and CG.
- The Chinese version of the Diabetes Management Self-Efficacy Scale Questionnaire [ Time Frame: At baseline, week 24 and week 36. ]The Diabetes Management Self-Efficacy Scale Questionnaire (C-DMSES) is a 20-item scale that assesses diabetes self-care, including blood glucose monitoring, dietary adherence and physical activity adherence. Participants are asked to read each of the 20 items and rate on a 0-10 Likert scale. Higher scale scores indicate better self-care behavior. This scale has been validated and shown satisfactory reliability (r=0.86) in research.
- The Chinese version of the Diabetes Empowerment Scale Questionnaire - Short Form [ Time Frame: At baseline, week 24 and week 36. ]The Chinese version of the Diabetes Empowerment Scale Questionnaire (C-DES) is a 10-item scale and includes five subscales: overcoming barriers, achieving goals, coping, determining suitable methods and obtaining support. Participants are asked to rate each of the 10 items on a 0-5 Likert scale. Higher scale scores indicate better self-efficacy. This scale has been validated and shown satisfactory reliability (r=0.95) in study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092569
|Contact: Siu Wai Maggie LAU, MPhil||(852) firstname.lastname@example.org|
|Diabetes Centre, Alice Ho Miu Ling Nethersole Hospital||Recruiting|
|Tai Po, New Territories, Hong Kong|
|Contact: Siu Wai Maggie LAU, MPhil|
|Principal Investigator:||Siu Wai Maggie LAU, MPhil||Chinese Univeristy of Hong Kong|