The WISE Study (WhatsApp Intervention for Sleep in the Elderly)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorHalu Oleo University
About this trial
Sleep hygiene education is an educational effort to teach healthy sleep habits and behaviors to improve sleep quality, duration, and regularity naturally without the use of medication; however, this approach has not been established in Indonesia. This study aims to establish a sleep hygiene education care model among lonely older adults with insomnia in Indonesia and to examine the immediate effects of the WISE Study (WhatsApp Intervention for Sleep in the Elderly) led by nurses to older adults loneliness with insomnia using a Digital Booklet. In this assessor-blinded, randomized controlled trial, participants will be randomly allocated to either the nurse-led WISE experimental group or the control group provided with usual care. The outcomes will include sleep parameters measured using the Indonesian version of the Insomnia Severity Index (ISI), Generalized Anxiety Disorder-7 (GAD-7), Geriatric Depression Scale-Short Form (GDS-SF), Brief Fatigue Inventory (BFI), Epworth Sleepiness Scale (ESS), and sleep diaries. The questionnaires will be assessed at pre-treatment, post-treatment, and one-month follow-up. Generalized estimating equations will be used to test the research hypotheses. Questionnaires will be assessed at pre-treatment, post-treatment, and one-month follow-up. We hypothesized that older adults who were loneliness with insomnia who underwent nurse-led WISE would experience greater improvements in sleep quality compared to participants in a control group who received usual care.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Elderly individuals diagnosed with loneliness
Reported experiencing sleep disturbances in the past 2 weeks, either continuously or intermittently
Experiencing insomnia with a total score of ≥ 8 on the Indonesian version of the Insomnia Severity Index (ISI) during screening
Able to communicate in Indonesian
Disqualifiers
Elderly individuals with dementia, delirium, severe mental retardation, or cognitive impairment that prevents them from understanding or assessing their own sleep experience.
Currently using new sleeping medication/stimulants
Trial design
Design model
Parallel
Treatments tested in this trial
Nurse-led WiSE intervention group
Other interventionUpon arrival at the initial meeting, participants will receive a workbook containing an overview and content of WISE, including sleep disorders, symptoms, causes of insomnia, sleep hygiene, and relaxation. At the beginning of the intervention and at the end of the fourth week after the intervention, an interventional nurse will meet with participants to assess their Insomnia Severity Index (ISI), Generalized Anxiety Disorder-7 (GAD-7), Geriatric Depression Scale-Short Form (GDS-SF), Brief Fatigue Inventory (BFI), Epworth Sleepiness Scale (ESS), and sleep diary. From week 1 to week 4, participants will receive daily education via WhatsApp.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Nurse-led WISE intervention groupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Changes in Insomnia Severity
Insomnia severity will be measured using the Indonesian version of the Insomnia Severity Index (ISI). The ISI has seven questions to assess sleep difficulties. The total score ranges from 0 to 28, with scores above 7 being associated with insomnia. Higher scores indicate more severe insomnia.
Time frame
At baseline to week 4 (after the intervention), and one month (follow-up)2
Changes in Epworth Sleepiness
Epworth Sleepiness will be measured using the Indonesian version of Epworth Sleepiness Scale (ESS) with a 8-item questionnaires with total scores 24. Higher scores presence of ESS.
Time frame
At baseline to week 4 (after the intervention), and one month (follow-up)3
Changes in Sleep parameters from sleep logs
Sleep parameters will be measured using Sleep Logs with a-6 item questionnaires that assess for daily sleep log. Higher scores presence poor of sleep
Time frame
At baseline to week 4 (after the intervention), and one month (follow-up)Secondary outcomes
1
Changes in level of Anxiety
Level of anxiety will be measured using the Indonesian version of the Insomnia Generalized Anxiety Disorder-7 (GAD-7). The total score ranges from 0 to 21. Higher scores indicate more depression.
Time frame
At baseline to week 4 (after the intervention), and one month (follow-up)2
Changes in level of depression
Level of depression will be measured using the Indonesian version of Geriatric Depression Scale-Short Form (GDS-SF) with a 15-item questionnaire that assesses the level of depression. Higher scores indicate more depression.
Time frame
At baseline to week 4 (after the intervention), and one month (follow-up)3
Changes in level of fatigue in a person - both in terms of intensity and its impact on daily activities
Level of fatigue will be measured using the Indonesian version of Brief Fatigue Inventory (BFI) with a 9-item questionnaire that assesses the level and impact of fatigue in the past 24 hours using a scale of 0-10, with the final score being the average of all items. Higher scores indicate more severe fatigue.
Time frame
At baseline to week 4 (after the intervention), and one month (follow-up)Sponsors and contacts
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Halu Oleo University
Lead sponsor
Chulalongkorn University
Sponsor institution
Chulalongkorn University
Collaborator
Source ClinicalTrials.gov
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