NCT07793292Toborzás még nem indult
Telehealth Educational Intervention for Adults With Type 2 Diabetes in Oman
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 28.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 160 (tervezett)
- Első benyújtás
- 2026. aug. 25.
- Kezdés
- 2026. nov. 1.
- Elsődleges befejezés
- 2027. nov. 30.
- Fő szponzor
- Sultan Qaboos University
- Betegségek
- 2-es típusú cukorbetegség
- NCT-szám
- NCT07793292
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 160
- 2026. nov. 1. és az elsődleges befejezés (2027. nov. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Más betegség
- Type 1 diabetes, gestational diabetes, or another diabetes type for which the intervention and outcome plan is not appropriate.
- Severe cognitive impairment, active psychosis, or another condition preventing informed consent or meaningful participation.
Egyéb
- Current pregnancy or planned pregnancy during follow-up.
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Sultan Qaboos University Hospital | Muscat | Omán | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.