Telehealth Educational Intervention for Adults With Type 2 Diabetes in Oman

NCT07793292 | Not Yet Recruiting

• 1 other identifier: IG/--/CON/C&M/26/389
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 2

Keywords

Telemedicine; Patient Education; Medication Adherence; Glycated Hemoglobin; Quality of Life; Oman

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to 6 months

• 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.

  Baseline to month 6.

Secondary Outcomes (4)

• Change in Positive Attitudes Towards Healthcare and Medication Score From Baseline to 6 Months

  Baseline to 6 Months

• Change in Diabetes-Specific Quality of Life From Baseline to 6 Months

  From Baseline to 6 Months

• Change in Medication-Adherence Beliefs and Behaviors

  Assessed at baseline, 3 months, and 6 months.

• Telehealth Usability and Satisfaction

  at months 3 and 6

Study Arms (2)

Usual Care Plus Telehealth Education

EXPERIMENTAL

Participants will continue usual diabetes care and receive 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 institutionally approved secure platform. The first 12 weeks will follow a standardized diabetes education curriculum, and weeks 13-24 will reinforce content, review personal goals, address barriers, and revisit topics as needed. The intervention is educational; research staff will not initiate, discontinue, or adjust medications.

Behavioral: Telehealth Educational Intervention

Usual Care Alone

ACTIVE COMPARATOR

This group continues established usual diabetes care at SQUH, including routine clinic review, medication management, laboratory testing, and standard education.

Behavioral: Telehealth Educational Intervention

Interventions

Telehealth Educational Intervention BEHAVIORAL

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.

Usual Care Alone; Usual Care Plus Telehealth Education

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (1)

Sultan Qaboos University Hospital

Muscat, Al Khoud, 123, Oman

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Medication Adherence

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Nahla Mansour Al Aali, PhD

  College of Nursing, Sultan Qaboos University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nahla Mansour Al Aali, PhD

CONTACT

+96899486539; n.alaali@squ.edu.om

Samia Salim Al-Harrasi, phD

CONTACT

+96896444731; samia2013@squ.edu.om

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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%).

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: De-identified individual participant data and analytic code may be made available after publication of the primary study findings. The protocol does not specify a fixed end date for availability.
• Access Criteria: Access to de-identified individual participant data and analytic code may be considered upon reasonable request after publication of the primary study findings. Access will be subject to approval by the principal investigator, relevant institutional and ethics authorities, and completion of an appropriate data-use agreement. Only the de-identified data and analytic code approved for sharing will be provided.

Locations

OM (1)