The WISE Study (WhatsApp Intervention for Sleep in the Elderly)
WISE
2 other identifiers
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2025
CompletedStudy Start
First participant enrolled
July 30, 2026
CompletedFirst Posted
Study publicly available on registry
August 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 3, 2026
August 7, 2026
August 1, 2026
2 months
December 3, 2025
August 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
At baseline to week 4 (after the intervention), and one month (follow-up)
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.
At baseline to week 4 (after the intervention), and one month (follow-up)
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
At baseline to week 4 (after the intervention), and one month (follow-up)
Secondary Outcomes (3)
Changes in level of Anxiety
At baseline to week 4 (after the intervention), and one month (follow-up)
Changes in level of depression
At baseline to week 4 (after the intervention), and one month (follow-up)
Changes in level of fatigue in a person - both in terms of intensity and its impact on daily activities
At baseline to week 4 (after the intervention), and one month (follow-up)
Study Arms (2)
Nurse-led WISE intervention group
EXPERIMENTALBehavioral: WISE Upon 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.
Control Group
NO INTERVENTIONParticipants received no education or treatment for 4 weeks.
Interventions
Upon 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Halu Oleo Universitylead
- Chulalongkorn Universitycollaborator
Study Sites (1)
Coastal area
Kendari, Southeast Sulawesi, 93232, Indonesia
Related Publications (1)
Hasan F, Prasetya EC, Gordon CJ, Romadlon DS, Chang KM, Bartlett DJ, Lin CJ, Gautama MSN, Izzati N, Chiu HY. Effects of nurse-led, web-based brief behavioral therapy on insomnia severity in patients in the chronic stage of stroke recovery: a preliminary randomized controlled trial. J Clin Sleep Med. 2025 Dec 1;21(12):2031-2040. doi: 10.5664/jcsm.11856.
PMID: 40904277BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 3, 2025
First Posted
August 7, 2026
Study Start
July 30, 2026
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 3, 2026
Last Updated
August 7, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share