An Interactive Mobile Care on Self-management Among T2DM with OSA

Not Applicable

Not yet recruiting

• Conditions: Obstructive Sleep Apnea; Type 2 Diabetes Mellitus (T2DM)

• Registration Number: NCT06760715
• Lead Sponsor: Chang Gung University of Science and Technology

Brief Summary

The aim of the second and third year is to construct the "Care model of improving for overweight or obese T2DM with OSA" based on the transtheoretical model, and to import an interactive m-health self-management (m-Health My OSA Coach; MOSAC)" cloud platform to examine the effectiveness of OSA in T2DM participants. A randomized controlled trial study design will be adopted. Eligible OSA participants who have been screened for OSA following the first stage will be invited to the second stage. The participants will be randomly divided into either experimental or control group with 1:1 ratio. The total duration of intervention program is 6 months. Only the experimental group receives the MOSAC intervention.

Detailed Description

Obstructive Sleep Apnea (OSA) is a common sleep disorder. It is estimated that nearly 1 billion adults are affected by OSA in worldwide. It is about 36-60% of Type 2 Diabetes Mellitus (T2DM) patients with OSA. Studies have shown that obesity is an independent risk factor for both OSA and T2DM, and the prevalence of obesity among adults in Taiwan has reached 45.4%. As a result, the incidence of T2DM has also increased annually and has become younger. For this reason, the OSA derived from it should not be underestimated. A three-year with longitudinal study will be conducted. In the first year, a cross-sectional study design is employed. Convenience sampling is used and 485 overweight community-based participants who will recruit from four diabetes co-care clinics in North and Central Taiwan. The Epworth Sleep Scale, Pittsburgh's Sleep Quality Index, Taiwanese depression Scale, Health Promotion Lifestyle Scale, and the home portable sleep monitor will be used for data collection. The aim of the second and third year is to construct the "Care model of improving for overweight or obese T2DM with OSA" based on the transtheoretical model, and to import an interactive m-health self-management (m-Health My OSA Coach; MOSAC)" cloud platform to examine the effectiveness of OSA in T2DM participants. A randomized controlled trial study design will be adopted. Eligible OSA participants who have been screened for OSA following the first stage will be invited to the second stage. The participants will be randomly divided into either experimental or control group with 1:1 ratio. The total duration of intervention program is 6 months. Only the experimental group receives the MOSAC intervention. All data will be collected at baseline, 3, and 6 months after intervention. Generalized estimating equation is employed to analyze the effectiveness of the intervention. Hopefully, the findings of this study will serve as a reference for the health care providers and will help construct a model of care for people with overweight and obese T2DM with OSA in the community.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-29
• Study Start: 2024-12-30
• Study First Submitted QC: 2025-01-04
• Last Update Submitted: 2025-01-04
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-02-15
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is the change in AHI (times/hour) detected by a home-use portable sleep monitor.	24weeks	AHI is represented by the number of apnea and hypopnea events per hour of sleep. In this study, OSA was defined as the value of AHI greater than 5 events/ hr. In addition, participants were determined as having mild, moderate, and severe OSA if they had AHI 5-14 events /hr, 15-30 events /hr, and \> 30 events /hr, respectively (Jonas et al., 2017).

Secondary Outcome Measures

Name	Time	Method
The secondary outcome measures include changes in OSA-related factors such as HbA1c, BMI, sleep quality, daytime sleepiness, depression, and health-promoting lifestyle.	24weeks	The secondary outcome measures include changes in OSA-related factors including (1) HbA1c in percentage (%), (2)weight in kilogram, (3)height in meters, (4) weight and height will be combined to report BMI( kg/m\^2), (5) Pittsburgh's Sleep Quality Index was used to examine sleep quality. The total score ranges from 0 to 21, high scores indicated a poor sleep, (6) Epworth Sleep Scale was used to assess the severity of participants' sleepiness while performing daily activities, the total score ranges from 0 to 24 points, higher scores indicated a higher chance of dozing, (7)Taiwanese Depression Questionnaire was used to assess depression, a total score ranged from 0 to 54 points, higher scores indicated a sever level of depression, (8) Health-Promoting Lifestyle Profile was used to examine participants' health-promoting lifestyle behavior, the total score ranges from 24 to 96 points, higher scores on individual indicated a higher level of engagement in health-promoting behaviors.

Trial Locations

Locations (1)

Primary Healthcare Centers and Diabetes Care Network Clinics; 🇨🇳 Miaoli, Taiwan