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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
120
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.
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.
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.
Time frame: Baseline, 4 months
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.
Time frame: Baseline and 12 months
Change in Duration of <90% oxygen desaturation
Duration of \<90% oxygen desaturation will be assessed by sleep test.
Time frame: Baseline, 4 months and 12 months
Change in body weight
Body weight will be measured.
Time frame: Baseline, 4 months and 12 months
Change in body fat
Body fat will be measured.
Time frame: Baseline, 4 months and 12 months
Change in body neck circumference
Neck circumference will be measured.
Time frame: Baseline, 4 months and 12 months
Change in waist circumference
Waist circumference will be measured.
Time frame: Baseline, 4 months and 12 months
Change in hip circumference
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Hip circumference will be measured.
Time frame: 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.
Time frame: Baseline, 4 months and 12 months
Change in Hand grip strength
Hand grip strength will be measured by a dynamometer.
Time frame: Baseline, 4 months and 12 months
Change in lower limb strength
Lower limb strength will be measured by a 30-second chair stand test.
Time frame: Baseline, 4 months and 12 months
Change in flexibility
Flexibility will be measured by a sit and reach test.
Time frame: Baseline, 4 months and 12 months
Change in balance
Balance will be measured by a single-leg stance test.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline, 4 months and 12 months
Change in dietary habits
Dietary habits will be measured by 10-item dietary intake and practice questionnaire.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 months and 12 months