Effectiveness of a Telehealth Educational Intervention on Glycemic Control, Medication Adherence, and Quality of Life Among Adults With Type 2 Diabetes in Oman: Study Protocol for a Two-Arm Parallel Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin A1c (HbA1c) From Baseline to 6 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Usual Care Plus Telehealth Education
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.
干预措施: Telehealth Educational Intervention (Behavioral)
Usual Care Alone
This group continues established usual diabetes care at SQUH, including routine clinic review, medication management, laboratory testing, and standard education.
干预措施: Telehealth Educational Intervention (Behavioral)
结局指标
主要结局
Change in Hemoglobin A1c (HbA1c) From Baseline to 6 Months
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Dr. Nahla Al Ali
Associate professor
Sultan Qaboos University