Promoting Insulin Initiation Among Suboptimal Diabetic Control Patients
NCT ID: NCT04207541
Last Updated: 2019-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
130 participants
INTERVENTIONAL
2019-10-01
2021-06-30
Brief Summary
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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).
Detailed Description
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About half of the diabetic patients who are having suboptimal glycemic control for 3-5 years and living with different extent of complications delay insulin therapy initiation. One of the reasons is patients' psychological insulin resistance (PIR), which is describing the reluctance to initiate insulin therapy, particularly prevalent in Chinese patients. In Hong Kong, a local study has revealed a similarly high PIR prevalence of 72.1%.
Effective educational programmes are needed for insulin-naive patients to enhance their understanding of the disease and treatment; and increase the acceptance and adherence of insulin therapy. This calls for effective educational programmes to help those patients in achieving better glycemic control in order to decrease risk of diabetic complications.
Brief Motivational Interviewing is an adaptation of motivational interviewing skills, which is designed to apply in a time-constraint clinical care environment and has been shown to improve patients' collaborations and satisfactions, the alliance between patients and doctors, and the adherence to treatment. Although this is an effective communication style, it has never been applied to educational programmes of insulin acceptance among T2DM patients with sub-optimal glycemic control.
Trial Objectives and Purpose This trial is to examine the effectiveness of brief motivational enhancement education programme in addition to usual care versus usual care only in improving insulin acceptance and insulin initiation among T2DM patients with sub-optimal glycemic control.
Trial Design To achieve the objectives, a quasi-experimental study on brief motivational enhancement education programme will be conducted.
Selection and Withdrawal of Subjects
Subjects will be included in the trial if they are:
1. Diagnosed with T2DM for more than six months
2. Chinese patients who can speak Cantonese/Mandarin
3. Chinese patients who can read Chinese
4. Aged ≥ 18 years
5. Suboptimal glycemic control whose latest HbA1c ≥ 7.5% with maximum oral dosage of OHAs.
6. Never used insulin before and prescribed to start insulin therapy
People will be excluded if they are:
1. Physical or mental ill that hindered them from completing the questionnaire or communicate, e.g., dementia, deafness, and severe visual problems
2. Pregnant
3. Gestational diabetic patients
People has the right to withdraw from the trial at any time without any impact on the current medical services and legal rights.
The study will be conducted in one of the primary care setting of Hospital Authority, Ap Lei Chau GOPC. Potential participants will be invited to participate when they are attending the clinic for their regular follow-up appointment. Eligible participants will first be explained the information sheet regarding the study. They will then be asked to sign the consent if they are willing to join the study.
Treatment of Subjects The study target to recruit two groups of eligible cases. The two groups will be recruited one by one. The first group recruited will act as control in comparison. In this group, all eligible participants will be invited to complete the 13-items Chinese Attitudes to Starting Insulin Questionnaire (Ch-ASIQ) before they see nurses. After having completed the questionnaires, they will be treated as usual care. The complications of suboptimal diabetic control will be told, at the same time, diet control and importance of regular exercise will also be reinforced as usual care. At the end of the session, they will be asked if they accept the referral to the insulin clinic for insulin therapy.
The interventional group of eligible cases will be recruited after the control group reached the pre-set numbers. In the interventional group, the eligible participants will be also invited to complete the Ch-ASIQ before they see nurses. Besides the usual care, all the participants in this group will also be treated with structured intervention. The information gathered through the questionnaires will be used in the intervention for this group of patients. The information will be delivered to the patients in the format of one 15-minute session of brief motivational interviewing. Pre-set script will be used for the brief motivational interviewing. At the end of the session, they will be asked if they accept the referral to the insulin clinic for insulin therapy.
The first 10 cases in the intervention group will act as pilot. Intervention will be revised if there are logistics problem seen.
Conditions
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Keywords
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Study Design
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SEQUENTIAL
PREVENTION
NONE
Study Groups
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Control group and Intervention group
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.
Brief motivational interview
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.
Interventions
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Brief motivational interview
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.
Eligibility Criteria
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Inclusion Criteria
1. Diagnosed with T2DM for more than six months
2. Chinese patients who can speak Cantonese/Mandarin
3. Chinese patients who can read Chinese
4. Aged ≥ 18 years
5. Suboptimal glycemic control whose latest HbA1c ≥ 7.5% with maximum oral dosage of OHAs.
6. Never used insulin before and prescribed to start insulin therapy
Exclusion Criteria
1. Physical or mental ill that hindered them from completing the questionnaire or communicate, e.g., dementia, deafness, and severe visual problems
2. Pregnant
3. Gestational diabetic patients
18 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Echo Ting-Ting Go
Doctoral Candidate
Principal Investigators
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Echo Ting Ting Go, Nursing
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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Hospital Authority
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Echo Ting Ting Go, Nursing
Role: primary
Echo Ting Ting Go, Nursing
Role: backup
Other Identifiers
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UW 19-614
Identifier Type: -
Identifier Source: org_study_id