Telehealth Educational Intervention for Adults With Type 2 Diabetes in Oman
ConditionDiabetes Mellitus Type 2
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSultan Qaboos University
About this trial
The goal of this clinical trial is to find out whether adding a nurse-led telehealth educational program to usual diabetes care can improve blood sugar control, medication-related behaviors, and quality of life in adults with type 2 diabetes in Oman.
The main question this study aims to answer is whether adults who receive the telehealth educational program, in addition to their usual diabetes care, have better blood sugar control after 6 months than adults who receive usual diabetes care alone. Blood sugar control will be assessed using hemoglobin A1c (HbA1c), a blood test that reflects average blood sugar levels over the previous few months.
The study will also examine whether the telehealth program improves participants' attitudes and behaviors related to taking their diabetes medicines and their diabetes-related quality of life. Among participants receiving the telehealth intervention, the study will also assess how easy, useful, reliable, and satisfactory they find the telehealth service.
Approximately 160 Omani adults with type 2 diabetes will take part in the study. Participants will be randomly assigned to one of two groups. One group will continue usual diabetes care and will also receive an individual telehealth education session once a week for 24 weeks. Each session will last about 20 to 30 minutes and will be provided by a trained nurse using an approved secure telehealth platform. The sessions will cover topics such as diabetes and HbA1c, safe use of medicines, strategies for remembering medicines, healthy eating, physical activity, blood glucose monitoring, recognition of low and high blood sugar, prevention of diabetes complications, stress and sleep, and communication with healthcare professionals.
The other group will continue to receive usual diabetes care without the additional study telehealth education program. No established diabetes care will be withheld from either group, and the telehealth education will not replace routine medical care or authorize the research team to change participants' medications.
Participants will be assessed at the start of the study, at 3 months, and at 6 months. Assessments will include HbA1c testing and questionnaires about medication-related beliefs and behaviors and diabetes-related quality of life. Participants in the telehealth group will also complete a questionnaire about their experience with and satisfaction with telehealth.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Omani national aged 18 years or older.
Confirmed type 2 diabetes mellitus (T2DM) documented in the medical record.
Prescribed at least one glucose-lowering medication and receiving treatment for at least 3 months before enrollment.
Most recent clinically valid HbA1c, or screening HbA1c when appropriate, 7.5% or higher.
Disqualifiers
Type 1 diabetes, gestational diabetes, or another diabetes type for which the intervention and outcome plan is not appropriate.
Current pregnancy or planned pregnancy during follow-up.
Severe cognitive impairment, active psychosis, or another condition preventing informed consent or meaningful participation.
Acute medical instability or hospital admission at recruitment.
Trial design
Design model
Parallel
Treatments tested in this trial
Telehealth Educational Intervention
BehavioralParticipants assigned to the intervention group will receive usual diabetes care plus one individual synchronous telehealth education session each week for 24 weeks. Sessions will generally last 20-30 minutes and will be delivered in Arabic or English by a trained diabetes nurse educator or research nurse using an SQU/SQUH-approved secure platform. Video will be encouraged when feasible; secure audio may be used if connectivity is insufficient. The first 12 weeks will follow a standardized curriculum covering diabetes and HbA1c, medication use and adherence strategies, healthy eating, physical activity, glucose monitoring, hypo- and hyperglycemia, complication prevention, stress and sleep, communication with healthcare professionals, and maintenance planning. Weeks 13-24 will reinforce content, review goals, address barriers, and revisit topics as needed. Research staff will not initiate, discontinue, or adjust medications; clinical questions will be referred to the treating team.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Usual Care Plus Telehealth EducationExperimental treatment 1 intervention
Group B: Usual Care AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Hemoglobin A1c (HbA1c) From Baseline to 6 Months
Measure: Change in Hemoglobin A1c (HbA1c) Description: HbA1c will be measured as a continuous percentage. The primary treatment effect is the adjusted between-group difference in change from baseline to month 6.
Time frame
Baseline to 6 months2
Change in Hemoglobin A1c (HbA1c)
HbA1c will be measured as a continuous percentage. The primary treatment effect is the adjusted between-group difference in change from baseline to month 6.
Time frame
Baseline to month 6.Secondary outcomes
1
Change in Positive Attitudes Towards Healthcare and Medication Score From Baseline to 6 Months
Measured using the Positive Attitudes Towards Healthcare and Medication domain of the MAUQ-ar-OM. The month-6 comparison is the principal secondary comparison; month 3 is supportive.
Time frame
Baseline to 6 Months2
Change in Diabetes-Specific Quality of Life From Baseline to 6 Months
Measured using the Diabetes Quality of Life Brief Clinical Inventory (DQOL-15). The month-6 comparison is principal; month 3 is supportive.
Time frame
From Baseline to 6 Months3
Change in Medication-Adherence Beliefs and Behaviors
Includes the MAUQ-ar-OM domains for lack of discipline, aversion towards medication, active coping with health problems, and the overall MAUQ-ar-OM score. Assessed at baseline, 3 months, and 6 months.
Time frame
Assessed at baseline, 3 months, and 6 months.4
Telehealth Usability and Satisfaction
Measured with the Arabic Telehealth Usability Questionnaire (TUQ-Arabic) at months 3 and 6, intervention group only. Your protocol treats this as a secondary outcome rather than a randomized between-group comparison.
Time frame
at months 3 and 6Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: