Obstructive Sleep Apnea (OSA)
Conditions
Keywords
self-management, OSA, digital health
Brief summary
This study is to assess the feasibility and acceptability of the PASS in patients with OSA. Second, the study examines its effectiveness in improving PAP uptake and adherence, self-efficacy in self-care, changes in health-related habits, and health outcomes. We also assess the facilitators and barriers to implementing the PASS. This is a two-group pilot randomized controlled trial (n=60) with a 4-month follow-up. Subjects assigned to the intervention group will receive a 4-month Personalized and Adaptive Sleep Support (PASS) program, a digital platform-based intervention. The 4-month program incorporates: i) a 20-minute brief motivational interviewing session; ii) a digital platform where users can view personalized OSA health-related videos and information, track their adherence to prescribed treatments, log their daily activities and dietary intake, and set personal health goals; and iii) continuous personalized chat-based messaging and phone call support. Participants in the control group will receive a 4-month general hygiene program, including (i) a 20-minute session, (ii) messaging, and (iii) phone call support. The feasibility and acceptability of the PASS will be evaluated via semi-structured interviews at the 4-month follow-up. Self-administered questionnaires will be used at baseline and 4 months, and objective assessment tools (such as sleep tests) will be used at baseline and at the 4-month follow-ups. PAP adherence data will be downloaded from PAP machines (if available) for all subjects in both groups at baseline and at month 4.
Detailed description
This is a two-group pilot randomised control trial with a 4-month follow-up. Forty subjects (30 for the intervention group and 30 for the control group) will be recruited Subject. Subjects in intervention group will receive a 4-month Personalized and Adaptive Sleep Support Program (PASS), a digital platform-based intervention guided by social cognitive theory and use brief motivational interviewing (brief MI) to enhance subjects' psychological capacity and motivation, feel confident in managing chronic situations, and provide continuous individual support. The PASS is a 4-month program utilizing a multimodal approach with three main components: i) A 20-Minute Brief Motivational Interviewing Session, ii) a digital platform, and iii) a continuous personalized chat-based messaging and phone call support. The 20-minute interviewing session utilizes Motivational Interviewing (MI) techniques to engage and motivate participants in managing their OSA. The digital platform providing multiple functions for OSA subjects, including self-selection of personalised OSA health-related videos and information, tracking Positive airway pressure treatment adherence, physical activity levels, diet, sleep habits, body weight, blood pressure, and setting personal health goals. The continuous personalized chat-based messaging and phone call support provides ongoing, tailored support and encouragement through messaging, helping to engage and adhere to the program. Participants receive additional support through regular phone calls, offering a more personal touch and the opportunity to address any specific concerns or challenges they may be facing. Participants in control group will receive a 4-month general hygiene program, including (i) A 20-minute session, (ii) messaging, and (iii) phone call support. Program feasibility and acceptability will be evaluated via semi-structured interviews at 4 months, while primary outcomes (PAP uptake) and secondary outcomes (including PAP adherence, self-efficacy, health-related habits, and quality of life) will be measured using a combination of self-administered questionnaires (e.g., SEMSA, ESS, ISI), objective activity trackers, and data retrieved from PAP machines at baseline and 4 months, with clinical outcomes like BMI and OSA severity assessed at baseline and the 4-month follow-up. Self-administered questionnaires will be used at baseline and 4 months, and objective assessment tools (such as sleep tests) will be used at baseline and 4-month follow-up. PAP adherence will be downloaded from PAP machines (if available) for all subjects in both groups at baseline and month 4. Individual interviews will be conducted after a 4-month program. The aims are to (i) explore subjects' perception and satisfaction with the programme, (ii) understand the impacts and extent to which the changes have sustained and integrated into their daily life; and (iii) identify elements of the programme they view as helpful/unhelpful in supporting them to increase self-management ability, (iv) explore the facilitators and barriers for exercise adherence. If subjects withdraw from the assessment or drop out of the programme, they will not be asked for the reasons, and it will not affect the current treatment and follow-up.
Interventions
BEHAVIORAL4-month Personalized and Adaptive Sleep Support program (PASS)
The 4-month Personalized and Adaptive Sleep Support (PASS) program incorporate 3 components: i) 20-minute brief motivational interviewing Session motivating participants, ii) digital platformThe digital platform enabling participants to access tailored health content, track PAP therapy adherence, log physical data such as activity and diet, and utilize integrated tools for self-monitoring and goal setting, iii) continuous personalized support offering chat-based messaging to promote program engagement and adherence.
BEHAVIORALControl group
Participants will receive a 4-month general hygiene program, including (i) A 20-minute session, (ii) messaging, and (iii) phone call support. The content focuses on hand hygiene and food hygiene
Sponsors
Hong Kong Metropolitan University
Queen Mary Hospital, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years and above * Newly diagnosed with OSA (diagnosis made within the past year) * Newly started or not yet started Positive Airway Pressure (PAP) treatment, with a treatment duration of less than 6 months * Physically inactive (self-reported moderate physical activity per week of \<150 minutes) * Overweight (BMI≥23 kg/m2) * Mentally, cognitively, and physically fit to join the trial as determined by the doctor in charge and responsible clinical investigators * Able to speak, read, and write Chinese * Willing to complete the questionnaires and assessments * Has a smartphone
Exclusion criteria
* Clinically significant psychiatric disorder * Use of prescription drugs or clinically significant drugs affecting sleep.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive airway pressure (PAP) therapy uptake | Baseline and 4 months | Whether the patient start to use the PAP therapy. Answer option: Yes or No |
| Program feasibility and acceptability | 4 months | Evaluated via semi-structured interviews |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive airway pressure therapy adherence - Intention to use | Baseline and 4 months | The percentage of days on which CPAP has been switched on (ie, total number of switch-on days divided by the total number of study days). Scores ranged from 0% to 100%. The high scores denote the better PAP use. |
| Positive airway pressure therapy adherence - mean daily usage | Baseline and 4 months | The total number of hours of mask on divided by the total number of study days, which was downloaded with software. Scores ranged from 0 to 24 hours. The high scores denote the better PAP use. |
| Positive airway pressure therapy adherence - Usage Index | Baseline and 4 months | The percentage of days using PAP for at least 4 h/d (ie, total number of such PAP days divided by the total number of study days). Scores ranged from 0% to 100%. The high scores denote the better PAP use. |
| Self-efficacy in self-management and treatment adherence | Baseline and 4 months | Measured by a 26-item Self-efficacy Measure for Sleep Apnea, with 3 subscales: the perceived risk of sleep apnea, PAP outcome expectations, and treatment self-efficacy. Scores of subscale ranged from 1 to 4. Higher scores indicate greater perceived self-efficacy, greater perceived response efficacy, and higher perceived susceptibility. |
| Dietary habits | Baseline and 4 months | Measured by a 10-item outcome-based dietary practice questionnaire. Scores ranged from 1 to 5. The higher scores indicate the worse dietary practice. |
| Physical activity level | Baseline and 4 months | Measured by an 4-item International Physical Assessment Questionnaire - short version. Ranged from 0 to 24 hours per day. The higher scores represent higher physical activity level. |
| Daytime sleepiness | Baseline and 4 months | Measured by an 8-item Epworth Sleepiness Scale. Scores ranged from 0 to 24. Higher scores indicate more sleepy during daytime. |
| Sleep quality | Baseline and 4 months | Measured by a 7-item Insomnia Severity Index. Higher scores indicate poorer sleep quality |
| Quality of life | Baseline and 4 months | Measured by a 10-item Functional Outcomes of Sleep Questionnaire. Total scores ranged from 5 to 20. The higher scores indicate better functional status. |
| Waist circumference | Baseline and 4 months | Measured by measuring tape |
| Body mass index | Baseline and 4 months | Calculated by height and weight |
| Body fat composition | Baseline and 4 months | Measured by bioimpedance scale |
| Severity of sleep apnoea | Baseline and 4 months | Measured by a Home-sleep test |
| Technology acceptance | 4 months | Measured by a 7-item modified Technology acceptance model questionnaire. Ranged 1 to 7 for each item. Higher scores indicate better acceptance. |
Countries
Hong Kong
Contacts
CONTACTYuen Kwan Agnes Lai, PhD
CONTACTOn Chu George Cheung, MPhil
PRINCIPAL_INVESTIGATORYuen Kwan Agnes Lai, PhD
Hong Kong Metropolitan University
Outcome results
None listed