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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
Sponsor:
Information provided by (Responsible Party):
LAU Siu Wai Maggie, Chinese University of Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Pre-medical consultation structured diabetes self-care education programme Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Usual care



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Siu Wai Maggie LAU, MPhil (852) 91526018 1092210290@link.cuhk.edu.hk

Locations
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Hong Kong
Diabetes Centre, Alice Ho Miu Ling Nethersole Hospital Recruiting
Tai Po, New Territories, Hong Kong
Contact: Siu Wai Maggie LAU, MPhil         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Siu Wai Maggie LAU, MPhil Chinese Univeristy of Hong Kong

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Responsible Party: LAU Siu Wai Maggie, Principal Investigator, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04092569     History of Changes
Other Study ID Numbers: 2019.255
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LAU Siu Wai Maggie, Chinese University of Hong Kong:
Pre-medical Consultation self-care education
Glycemic control
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases