Diabetes Mellitus Type 2
Conditions
Keywords
Telemedicine; Patient Education; Medication Adherence; Glycated Hemoglobin; Quality of Life; Oman
Brief summary
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.
Detailed description
Type 2 diabetes requires ongoing self-management between routine clinic visits. This includes taking medications as prescribed, following healthy eating and physical activity recommendations, monitoring blood glucose when appropriate, and recognizing and preventing complications. Regular clinic visits may not provide enough time for repeated education, reinforcement, and problem-solving. Telehealth may provide a practical way to extend structured diabetes education beyond face-to-face visits and offer more continuous support. However, randomized evidence on culturally tailored, nurse-led telehealth education for adults with type 2 diabetes in Oman remains limited. This study is a prospective, single-site, two-arm, parallel-group randomized controlled trial designed to evaluate the effectiveness of a structured telehealth educational intervention for adults with type 2 diabetes in Oman. The study will compare usual diabetes care plus telehealth education with usual diabetes care alone. The main aim is to determine whether adding telehealth education to usual care improves glycemic control over 6 months. The study will also examine medication-related beliefs and behaviors, diabetes-related quality of life, and participants' experiences with telehealth. The telehealth intervention will be delivered individually by a trained diabetes nurse educator or research nurse using an institutionally approved secure platform. Participants assigned to the intervention group will receive one telehealth education session each week for 24 weeks, in addition to their usual diabetes care. Sessions will generally last 20 to 30 minutes and will be provided in Arabic or English according to participant preference and need. During the first 12 weeks, participants will receive a structured educational curriculum. Topics will include understanding type 2 diabetes and hemoglobin A1c (HbA1c), safe use of diabetes medicines, strategies for remembering medicines, healthy eating, physical activity, blood glucose monitoring, recognition and management of low and high blood sugar, and prevention of diabetes-related complications. Education will also address managing diabetes during illness, travel, fasting, and changes in daily routines; stress and sleep; social support; communication with healthcare professionals; and long-term self-management planning. During weeks 13 to 24, the sessions will reinforce earlier content, review personal goals, address barriers, and revisit topics according to participants' needs. The intervention is educational and will not replace routine clinical care. Research staff will not start, stop, or change participants' medications. Questions requiring clinical decisions will be referred to the participant's treating healthcare team. Participants in the comparison group will continue to receive the usual diabetes care provided by Sultan Qaboos University Hospital, including routine clinical follow-up, medication management, laboratory testing, and standard diabetes education. The primary focus of the trial is glycemic control, assessed using HbA1c. The study will also evaluate medication-related beliefs and behaviors and diabetes-specific quality of life. Among participants receiving telehealth education, the study will assess perceptions of the usefulness, ease of use, reliability, and satisfaction with telehealth. Information on participation in telehealth sessions, technical problems, intervention delivery, retention, referrals, and safety will also be collected to help determine the feasibility and acceptability of the program. The first 30 randomized participants will form an internal feasibility pilot. This pilot will examine recruitment, consent, attendance, platform performance, data completeness, privacy issues, and participant retention. It will not include formal comparative testing of the effectiveness of the intervention. Findings from the pilot may be used to make minor operational improvements that do not change the study objectives, eligibility criteria, outcomes, or randomization procedures. This study is expected to provide evidence about whether a structured, culturally tailored, nurse-led telehealth education program can strengthen diabetes self-management and improve outcomes for adults with type 2 diabetes in Oman. If the program is effective and acceptable, it may provide a model for extending diabetes education and support beyond routine clinic visits.
Interventions
BEHAVIORALTelehealth Educational Intervention
Participants 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.
Sponsors
Sultan Qaboos University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Prospective, single-site, two-arm, parallel-group superiority randomized controlled trial with 1:1 allocation. After informed consent and baseline assessment, participants will be randomly assigned to usual diabetes care plus weekly telehealth education for 24 weeks or to usual diabetes care alone. Outcomes will be assessed at baseline, 3 months, and 6 months. Randomization will use concealed, randomly varied block sizes of 4 and 6, stratified by sex and baseline HbA1c (\<9.0% vs ≥9.0%).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must meet all of the following: * 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. * Access to an internet-enabled smartphone, tablet, or computer and ability to participate in video- or audio-supported telehealth sessions. * Able to understand Arabic or English sufficiently to provide informed consent and participate in study procedures, and able to complete the validated Arabic Oman version of the medication-adherence questionnaire. * Willingness to be randomized and availability for 6 months of follow-up.
Exclusion criteria
* 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. * Participation in another interventional study that could materially affect trial outcomes. * Inability to use telehealth even with reasonable assistance or absence of a private and safe setting for sessions. * Another clinical or ethical reason identified by the treating clinician or principal investigator that makes participation inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) From Baseline to 6 Months | 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. |
| Change in Hemoglobin A1c (HbA1c) | Baseline to month 6. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes-Specific Quality of Life From Baseline to 6 Months | 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. |
| Change in Medication-Adherence Beliefs and Behaviors | Assessed at baseline, 3 months, and 6 months. | 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. |
| Telehealth Usability and Satisfaction | at months 3 and 6 | 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. |
| Change in Positive Attitudes Towards Healthcare and Medication Score From Baseline to 6 Months | 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. |
Countries
Oman
Contacts
CONTACTNahla Mansour Al Aali, PhD
CONTACTSamia Salim Al-Harrasi, phD
PRINCIPAL_INVESTIGATORNahla Mansour Al Aali, PhD
College of Nursing, Sultan Qaboos University
Outcome results
None listed