Effectiveness of Pre-medical Consultation Diabetes Self-care Education Programme on Glycemic Control in Type 2 Diabetes

NCT04092569 | Unknown DMC

• 1 other identifier: 2019.255
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Pre-medical Consultation self-care education; Glycemic control

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• The Chinese version of the Diabetes Management Self-Efficacy Scale Questionnaire

  At baseline, week 24 and week 36.

• The Chinese version of the Diabetes Empowerment Scale Questionnaire - Short Form

  At baseline, week 24 and week 36.

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Pre-medical consultation structured diabetes self-care education programme

Behavioral: Pre-medical consultation structured diabetes self-care education programme

Control group

NO INTERVENTION

Usual care

Interventions

Pre-medical consultation structured diabetes self-care education programme BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Diabetes Centre, Alice Ho Miu Ling Nethersole Hospital

Tai Po, New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Siu Wai Maggie LAU, MPhil

  Chinese Univeristy of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siu Wai Maggie LAU, MPhil

CONTACT

(852) 91526018; 1092210290@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: September 17, 2019
• Study Start: September 10, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

HK (1)