Promoting Insulin Initiation Among Suboptimal Diabetic Control Patients

NCT04207541 | Unknown

• 1 other identifier: UW 19-614
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Delay in commencing insulin among type 2 Diabetes Mellitus (T2DM) patients is common. One of the reasons is patients' psychological insulin resistance (PIR), which is particularly prevalent in Chinese patients. The Chinese Attitudes to Starting Insulin Questionnaire (Ch-ASIQ) is the shortest locally validated questionnaire which is developed to understand the condition of PIR in T2DM patients while brief motivational interviewing has been shown to improve patients' collaborations and satisfactions, the alliance between patients and doctors, and the treatment adherence. Therefore, this study aims to investigate the efficacy of a one-session educational intervention targeting psychological insulin resistance guided by Ch-ASIQ in promoting the insulin acceptance and initiation. A quasi-experimental study will be conducted on 130 insulin-naïve T2DM patients recruited from a primary care setting. Eligible participants in the intervention group will be treated with one 15-minute brief motivational interviewing guided by Ch-ASIQ while those in control group will be treated with usual care. Both groups will be further followed up for 6 months to observe for their insulin initiation. The primary outcomes: i. the proportion of patient referral to insulin clinic (insulin acceptance), and ii. the proportion of patient with insulin initiation (actual start of insulin therapy).

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; insulin initiation; Brief motivational interview; Psychological insulin resistance

Outcome Measures

Primary Outcomes (2)

• Proportion of insulin acceptance

  It is related to the proportion of participants who agree to be referred to insulin clinic for considering insulin initiation.

  The acceptance is assessed on the same day of recruitment after education session has been provided to the participants.

• Proportion of insulin initiation

  It is related to the proportion of participants who agree to start insulin therapy after attending the insulin clinic.

  For those participants who start insulin therapy in 6 months after the education session will be regarded as "insulin initiation".

Study Arms (1)

Control group and Intervention group

EXPERIMENTAL

For control group, participants will be treated with usual care. For intervention group, participants will be provided a session of education regarding insulin initiation with brief motivation interviewing.

Behavioral: Brief motivational interview

Interventions

Brief motivational interview BEHAVIORAL

Client (who has suboptimal diabetic control with oral anti-diabetic agent) will be advised for insulin initiation with brief motivational interviewing in one session of individual education.

Control group and Intervention group

Eligibility Criteria

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

You may qualify if:

• Subjects will be included in the trial if they are:
• Diagnosed with T2DM for more than six months
• Chinese patients who can speak Cantonese/Mandarin
• Chinese patients who can read Chinese
• Aged ≥ 18 years
• Suboptimal glycemic control whose latest HbA1c ≥ 7.5% with maximum oral dosage of OHAs.
• Never used insulin before and prescribed to start insulin therapy

You may not qualify if:

• People will be excluded if they are:
• Physical or mental ill that hindered them from completing the questionnaire or communicate, e.g., dementia, deafness, and severe visual problems
• Pregnant
• Gestational diabetic patients

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Hospital Authority

Hong Kong, No Postcode, 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

• Echo Ting Ting Go, Nursing

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Echo Ting Ting Go, Nursing

CONTACT

25185607; echogott@connect.hku.hk

Ting Ting Go, Nursing

CONTACT

25185610; echogott@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Masking Details: Participant does not know which group they are assigned to.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Candidate

Model Details: Recruit control group first then interventional group.

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: December 23, 2019
• Study Start: October 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: June 30, 2021
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)