A Smart Sleep Apnea Self-management Support Programme(4S) for Subjects With Sleep Apnea

Study Overview
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Brief Summary
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OSA is a chronic disease with high prevalence that parallels with increasing obesity. Self-management programmes are perceived to be cost-effective in long-term OSA patient care and can supplement regular medical treatments. The current study attempt to examine the effectiveness of 4S on improving apnea severity, cardiovascular health and quality of life in 4S intervention (4S) group, compared to the general hygiene (GH) control group.

Detailed Description
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OSA is a chronic disease with high prevalence that parallels with increasing obesity. OSA affects around 12% and 24% of adults in Hong Kong and China Mainland, respectively. Chronic intermittent hypoxia and sleep fragmentation of OSA leads to cardiometabolic and neurocognitive sequelae (e.g. hypertension, diabetes, daytime sleepiness and depression). Long-term, multidisciplinary management involving patients in decision-making of treatment strategies, shifting from positive airway pressure (PAP) device-focused to the patient-centered chronic care model has been suggested. Mobile instant messaging (such as WhatsApp/WeChat) are popular and inexpensive for interactive messaging. Smartphone-based self-management interventions were reported improved self-efficacy and clinical outcomes in patients with chronic diseases. The investigator only found one mobile health application to support CPAP therapy for OSA and one ongoing trial of OSA self-management telematic support to improve CPAP adherence. There is underutilization of mobile technology in patient-centered self-management programmes to improve PAP treatment and lifestyle modifications in OSA. The current study attempt to examine the effectiveness of 4S on improving apnea severity, cardiovascular health and quality of life in 4S intervention (4S) group, compared to the general hygiene (GH) control group. Questionnaire and simple fitness assessment will be used to assess the effectivness of the intervention at 4-month and 12-month follow-up. Focus group interview will be conducted to collect qualiatative feedback on the intervention.

Official Title
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A Smart Sleep Apnea Self-management Support Programme(4S) to Improve Apnea Severity and Cardiovascular Health - A Pragmatic Randomized Controlled Trial With Mixed-method Evaluation

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Behavioral: Smart Sleep Apnea Self-management Support Programme (4S)
* Behavioral: General Hygiene Information (GH)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18 years and above; diagnosis of moderate to severe obstructive sleep apnea (AHI≥15); 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 and read Chinese; willing to complete the questionnaires and assessments; has a smartphone with instant messaging function (eg. WhatsApp/WeChat); and willing to give informed consent. Exclusion Criteria: sleep disorder other than OSA; clinically significant psychiatric, neurological, or medical disorder other than OSA; and use of prescription drugs or clinically significant drugs affecting sleep.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a 2-group randomisation controlled trial with 4-month and 12-month follow-up. The Experimental group will receive 4S intervention in relation to self-management and the Control group will receive general hygiene information.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart Sleep Apnea Self-management Support Programme (4S)<br>Patients will receive Smart Sleep Apnea Self-management Support Programme (4S) in addition to usual care | Behavioral: Smart Sleep Apnea Self-management Support Programme (4S)<br>* The experimental group will receive usual care and Smart Sleep Apnea Self-management Support Programme (4S). The 4S includes two interview sessions, instant messages, phone calls, continuous personalized chat-based messaging and phone call support and hotline services in relation to self-management. An e-platform will be used for self-monitoring and group sharing sessions will be conducted for experience sharing.<br>* Other names: 4S group;|
| Placebo Comparator: General Hygiene Information (GH)<br>Patients will receive general hygiene information (GH) in addition to usual care | Behavioral: General Hygiene Information (GH)<br>* The control group will receive usual care and general hygiene information (GH). The GH includes two GH sessions, instant messages, phone calls, continuous personalized chat-based messaging and phone call support and hotline services in relation to general hygiene information. An e-platform will be used for self-monitoring and group sharing sessions will be conducted for experience sharing.<br>* Other names: GH group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in apnea hypopnea index | Apnea hypopnea index will be asssessed by sleep test. The apnea hypopnea index is the number of times of apnea or hypopnea during one night, divided by the hours of sleep. The higher the apnea hypopnea index, the more severe sleep apnea is. | Baseline, 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in apnea hypopnea index | Apnea hypopnea index will be assessed by sleep test. The apnea hypopnea index is the number of times of apnea or hypopnea during one night, divided by the hours of sleep. The higher the apnea hypopnea index, the more severe sleep apnea is. | Baseline and 12 months | 
| Change in Duration of <90% oxygen desaturation | Duration of <90% oxygen desaturation will be assessed by sleep test. | Baseline, 4 months and 12 months | 
| Change in body weight | Body weight will be measured. | Baseline, 4 months and 12 months | 
| Change in body fat | Body fat will be measured. | Baseline, 4 months and 12 months | 
| Change in body neck circumference | Neck circumference will be measured. | Baseline, 4 months and 12 months | 
| Change in waist circumference | Waist circumference will be measured. | Baseline, 4 months and 12 months | 
| Change in hip circumference | Hip circumference will be measured. | Baseline, 4 months and 12 months | 
| Change objective physical activity level | Steps count and acceleration pattern of physical activity will be measured by a 7-day waist-worn accelerometer. | Baseline, 4 months and 12 months | 
| Change in Hand grip strength | Hand grip strength will be measured by a dynamometer. | Baseline, 4 months and 12 months | 
| Change in lower limb strength | Lower limb strength will be measured by a 30-second chair stand test. | Baseline, 4 months and 12 months | 
| Change in flexibility | Flexibility will be measured by a sit and reach test. | Baseline, 4 months and 12 months | 
| Change in balance | Balance will be measured by a single-leg stance test. | Baseline, 4 months and 12 months | 
| Change in daytime sleepiness | Daytime sleepiness will be measured by a 8-item Epworth Sleepiness Scale with a 3-point Likert scale. Total scores range from 0 to 24. Higher scores reflect greater daytime sleepiness. | Baseline, 4 months and 12 months | 
| Change in sleep quality | Sleep quality will be measured by a 7-item Insomnia Severity Index with a 4-point Likert scale. Total scores range from 0 to 28. Higher scores reflect greater severity of insomnia. | Baseline, 4 months and 12 months | 
| Change in functional outcomes of sleep | Functional outcomes of sleep will be measured by 10-item Functional Outcomes of Sleep Questionnaire with a 4-point Likert scale. Total scores range from 10 to 40. Higher scores reflect better functional outcomes of sleep. | Baseline, 4 months and 12 months | 
| Change in quality of life | Quality of life will be measured by 5-item EuroQol 5-Dimension questionnaire. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | Baseline, 4 months and 12 months | 
| Change in anxiety symptoms | Anxiety symptoms will be measured by Generalised Anxiety Disorder Assessment (GAD-7) with a 3-point Likert scale. Total scores range from 0 to 21. Higher scores reflect more higher anxiety symptoms. | Baseline, 4 months and 12 months | 
| Change in depressive symptoms | Depressive symptoms will be measured by 9-item Patient Health Questionnaire-9 (PHQ-9) with a 3-point Likert scale. Total scores range from 0 to 27. Higher scores reflect more higher depressive symptoms. | Baseline, 4 months and 12 months | 
| Change in subjective happiness | Subjective happiness will be measured by 4-item Subjective Happiness Scale with a 7-point Likert scale. Total scores range from 4 to 28. The highest scores reflect greater happiness. | Baseline, 4 months and 12 months | 
| Change in subjective physical activity level | Subjective physical activity level will be measured by 8-item International Physical Assessment Questionnaire -short version | Baseline, 4 months and 12 months | 
| Change in dietary habits | Dietary habits will be measured by 10-item dietary intake and practice questionnaire. | Baseline, 4 months and 12 months | 
| Change in self-efficacy in CPAP use | Self-efficacy in CPAP use will be measured by a 26-item Self-efficacy Measure for Sleep Apnea. Each Item ranges from 1 to 4: Higher scores indicate greater perceived self-efficacy, greater perceived response efficacy, and higher perceived susceptibility. | Baseline, 4 months and 12 months | 
| Change in exercise and dietary control self-efficacy | Exercise and dietary control self-efficacy will be measured by outcome-based questionnaire. Each item ranges from 1-10. The higher scores indicate higher self-efficacy | Baseline, 4 months and 12 months | 
| Change in perceived support from family and peers | Perceived support from family and peers measured by a 8-item Multidimensional Scale of Perceived Social Support with a 7-point Likert scale. Total scores for both family and peer subscales range from 4 to 28. Higher scores reflect better perceived social support. | Baseline, 4 months and 12 months | 
| Change in patient activation | Knowledge, skills and confidence in self-management were measured by a 13-item Patient Activation Measure Scale. The total score ranges from 0 (no activation) to 100 (high activation), with higher scores denoting the better patient activation. | Baseline, 4 months and 12 months | 
| Intervention credibility | The rationale of the delivered treatment and its efﬁcacy to alleviate sleep apnea will be measured using the 4-item Credibility of Treatment Rating Scale. Each item ranges from 1-6. The higher scores indicate higher credibility. | 4 months and 12 months |