Type 2 Diabetes Clinical Trial
— PMC-SEPOfficial title:
The Effectiveness of Pre-medical Consultation (PMC) Diabetes Self-care Education Programme on Glycemic Control in Adults With Type 2 Diabetes
This proposed project is a prospective randomized controlled trial to examine the clinical effects of pre-medical consultation structured diabetes self-care education program on intervention group (IG) versus control group (CG) for patients with type 2 diabetes in a specialist outpatient clinic of a regional hospital.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Type 2 Diabetes, age above 18 years old, who are 'newly referred' (established as well as newly diagnosed of DM) to specialist out-patient clinic at Alice Ho Miu Ling Nethersole Hospital - Suboptimal glycemic control of glycosylated haemoglobin, HbA1c >7% - Chinese and literate, able to answer questionnaires Exclusion Criteria: - Inability to give informed consent. - Poor glycemic control with glycosylated haemoglobin, HbA1c >12% and/or related complications will receive early medical appointment or require hospital admission. - Having advanced diabetes related complications, e.g. diabetes kidney disease with glomerular filtration rate (eGFR) <30 mL/min/1.72m2 - Life threatening condition with reduced life expectancy such as patients with cancer at terminal stage. - Those with active mental disorders and learning disability. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Diabetes Centre, Alice Ho Miu Ling Nethersole Hospital | Tai Po | New Territories |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Blood Glycosylated haemoglobin, HbA1c at 6 months | Blood HbA1c will be taken at baseline diabetes complication screening, week 24 for both IG and CG. | At baseline, week 24. | |
Primary | Change from Baseline Blood Glycosylated haemoglobin, HbA1c at 9 months | Blood HbA1c will be taken at baseline diabetes complication screening week 36 for both IG and CG. | At baseline, week 36. | |
Secondary | The Chinese version of the Diabetes Management Self-Efficacy Scale Questionnaire | 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. | At baseline, week 24 and week 36. | |
Secondary | The Chinese version of the Diabetes Empowerment Scale Questionnaire - Short Form | 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. | At baseline, week 24 and week 36. |
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