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Effectiveness of an Insulin Therapy Education Intervention (ITEI) on Insulin Adherence among Patients with Type 2 Diabetes Mellitus: A Randomized Control Trial

Effectiveness of an Insulin Therapy Education Intervention (ITEI) on Insulin Adherence among Patients with Type 2 Diabetes Mellitus: A Randomized Control Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000113651
Acronym
ITEI (Insulin Therapy Education Intervention)
Enrollment
84
Registered
2023-02-01
Start date
2023-03-01
Completion date
2023-03-31
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Insulin therapy education intervention (ITEI) planning by the researcher to analyze the effectiveness of the intervention among poor adherence insulin therapy patients. In terms of Insulin Therapy adherence, there is no specific module compiled and used among diabetes nurses to improve adherence among insulin users. In addition, many different sources of educational material have been used among healthcare workers to educate diabetes patients. Despite knowing that the educational method is one of the effective methods to improving adherence until now, in Malaysia, there is still no specific module and standardized module used and applied among diabetes educators to improve adherence. Perhaps ITEI module improve the adherences, knowledge on insulin and provide good outcome in HbA1c among patients who received insulin therapy.

Interventions

The participants in this study are adults with type 2 Diabetes mellitus (T2DM) who have poor adherence towards insulin therapy. Participants must receive insulin therapy minimum for 1 year and need to attend sessions for ITEI health education module by a diabetes educator, need to give a 3ml blood sample (HbA1c) in the first weeks, 12th weeks and 24th weeks during this six-month duration of the study. There is a three-part session of the ITEI Module, which is parts 1, 2, and 3. all three part

The participants in this study are adults with type 2 Diabetes mellitus (T2DM) who have poor adherence towards insulin therapy. Participants must receive insulin therapy minimum for 1 year and need to attend sessions for ITEI health education module by a diabetes educator, need to give a 3ml blood sample (HbA1c) in the first weeks, 12th weeks and 24th weeks during this six-month duration of the study. There is a three-part session of the ITEI Module, which is parts 1, 2, and 3. all three parts will be incorporated into each session. Method delivery of this education intervention include physical (face to face) discussion/consultation involve demonstration, motivational interviewing, virtual consultation and provide interactive video and slide. All material include of slide and video been provided and designed for this study. All material go through the validation phase among 4 expertise person ( Endocrinologist, Dietitian, Diabetes Educator, family medicine specialist) in this endocrine fields. The content of education for this study call as Insulin Therapy Education Intervention (ITEI). The frequency of the session is once a months for the face to face session covering all the parts, Meanwhile within 2 weeks for the virtual consultation/ phone consultation for review self monitoring blood sugar and provide interactive video/slide. All session will be run individually and time is flexible according the patient availability time. Attendance will be monitored, if patient absent the next appointment will be reschedule. The strategy to monitored adherences is using questionnaire (Adherences Scale assessment) every 2 months. Part One: Part one will start with setting up the mutual agreement for care. A patient will be given a personal diary to list down the goal, methods to achieve the target, and reasons to be analysed if the target is not achieved. Health Education will be covered a topic on nine topics of health education that are currently used same with the control group (Diabetes, medication, diabetes emergency, exercises, footcare, self-monitoring blood glucose, wound care, insulin), diabetes distress, approaching and involving peer support to helping the client in managing diabetes. Part two: Part two of ITEI, the session will cover empowerment on diabetes self-care -motivational section session using Health belief model and Theories of Learning &Behaviourism to understand the content of health education that has been delivered, insulin injection technique demonstration and competency (practical section), lipodystrophy recognition, insulin storage practices, insulin adjustment/titration, a home task for self-monitoring blood glucose (SMBG), telephone consultation for any issued update, simple relaxation section technique base on the result of diabetes distress and Depression Anxiety Stress Scale (DASS). Lastly, the patient will be updating analysing personal diary targets based on a personal objective that has been set up before. Part Three: The last part of the ITEI module will be covering on problem-solving, stress management, planning intervention, and motivational section. Each education session will take minimally 30 minutes and a maximum of 2 hours for each activities/consultation. Telephone consultation will be taken within five to 10 minutes , however may be longer according to patient needs. Participant will be giving questionnaire on knowledge on insulin, adherence, diabetes distress and mental status (depression, anxiety, stress) and insulin injection technique competency as well as HbA1c will taking on pre (1st week), middle (12th week) and end (24th week).

Sponsors

Nur Shazwaniza Yahya
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Poor adherences level towards medication/Insulin • Poor knowledge on Medication/Insulin • Not presenting of complications (Retinopathy, Stroke, Neuropathy, Nephropathy), • Having glucometer machine • Have access to mobile contact • Making self-injecting insulin which is not asking help for others person • Used insulin pen as devices at least for one years of durations. . Type 2 DM

Exclusion criteria

• Good adherences to medication/insulin • Using syringe as method of administered insulin • Present with complications (Retinopathy, Stroke, Neuropathy, Nephropathy). • Pregnant

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026