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| Name | Class |
|---|---|
| Queen Mary Hospital, Hong Kong | OTHER |
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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, 2 months, and 4 months, and objective assessment tools (such as sleep tests) will be used at baseline and at the 2- and 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.
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, 2 months, 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, 2 months, and 4 months, and objective assessment tools (such as sleep tests) will be used at baseline, 2-, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Participants will receive a 4-month general hygiene information. |
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| Intervention group | Experimental | Subjects in this arm will receive a 4-month digital Personalized and Adaptive Sleep Support program (PASS). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-month Personalized and Adaptive Sleep Support program (PASS) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PAP uptake | Whether the patient start to use the PAP therapy | Baseline, 2 months and 4 months |
| Program feasibility and acceptability | Evaluated via semi-structured interviews | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| PAP adherence - Intention to use | 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). | Baseline, 2 months and 4 months |
| PAP adherence - mean daily usage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuen Kwan Agnes Lai, PhD | Contact | (852)3970-2917 | ayklai@hkmu.edu.hk | |
| On Chu George Cheung, MPhil | Contact | (852)3970-2933 | occheung@hkmu.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Yuen Kwan Agnes Lai, PhD | Hong Kong Metropolitan University | Principal Investigator |
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It has not been mentioned during the IRB application
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Behavioral | 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 |
|
The total number of hours of mask on divided by the total number of study days, which was downloaded with software
| Baseline, 2 months and 4 months |
| PAP adherence - Usage Index | The percentage of days using CPAP for at least 4 h/d (ie, total number of such CPAP days divided by the total number of study days). | Baseline, 2 months and 4 months |
| Self-efficacy in self-management and treatment adherence | Measured by a 26-item Self-efficacy Measure for Sleep Apnea, with 3 subscales: the perceived risk of obstructive sleep apnea, CPAP outcome expectations, and treatment self-efficacy. High scores on the perceived risk scale denote greater perceived risks of OSA; high scores on the outcome expectations scale denote more positive beliefs about treatment; high scores on the treatment self-efficacy scale denote a greater willingness to engage in CPAP treatment despite certain obstacles. | Baseline, 2 months and 4 months |
| Exercise and dietary control self-efficacy | Measured by 2-item outcome-based questionnaire | Baseline, 2 months and 4 months |
| Dietary habits | Measured by a 10-item dietary intake and practice questionnaire | Baseline, 2 months and 4 months |
| Physical activity level | Measured by an 4-item International Physical Assessment Questionnaire - short version | Baseline, 2 months and 4 months |
| Steps count | Measured by an activity trackers | Baseline, 2 months and 4 months |
| Daytime sleepiness | Measured by an 8-item Epworth Sleepiness Scale. Higher score indicates more sleepy during daytime | Baseline, 2 months and 4 months |
| Sleep quality | Measured by a 7-item Insomnia Severity Index. Higher scores indicates poorer sleep quality | Baseline, 2 months and 4 months |
| Quality of life | Measured by a 10-item Functional Outcomes of Sleep Questionnaire and a 5-item EuroQol 5-Dimension questionnaire. Higher score indicates better quality of life | Baseline, 2 months and 4 months |
| Waist circumference | Measured by measuring tape | Baseline and 4 months |
| Body mass index | Calculated by height and weight | Baseline and 4 months |
| Body fat composition | Measured by bioimpedance scale | Baseline and 4 months |
| Blood pressure | Measured by sphygmomanometer | Baseline and 4 months |
| Severity of sleep apnoea | Measured by a Home-sleep test | Baseline and 4 months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D008722 | Methods |