The WISE Study (WhatsApp Intervention for Sleep in the Elderly)

NCT07751458 — Not applicable, Not yet recruiting, 50 participants, Halu Oleo University

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The WISE Study (WhatsApp Intervention for Sleep in the Elderly): Targeting Insomnia and Loneliness With a Digital Booklet

RegistryNCT07751458, acronym WISE
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment50 (Estimated)
SponsorHalu Oleo University (Other); collaborators: Chulalongkorn University
ConditionsLoneliness, Insomnia
InterventionsNurse-led WiSE intervention group (Other)
Datesstart 2026-07-30 (estimated), primary completion 2026-09-30 (estimated), completion 2026-12-03 (estimated), first posted 2026-08-07, last updated 2026-08-07
Locations1 site in Indonesia

Related Papers Related Patents Related Grants Related Experts
All trials for Loneliness All trials for Insomnia All trials of Nurse-led WiSE intervention group

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Nurse-led WISE intervention groupExperimentalOther: Nurse-led WiSE intervention groupBehavioral: 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 GroupNo interventionParticipants received no education or treatment for 4 weeks.
  • Nurse-led WiSE intervention group (Other): 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.

+Outcome measures

Primary outcomes

  • Changes in Insomnia Severity [At baseline to week 4 (after the intervention), and one month (follow-up)]: 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.
  • Changes in Epworth Sleepiness [At baseline to week 4 (after the intervention), and one month (follow-up)]: 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.
  • Changes in Sleep parameters from sleep logs [At baseline to week 4 (after the intervention), and one month (follow-up)]: 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

Secondary outcomes

  • Changes in level of Anxiety [At baseline to week 4 (after the intervention), and one month (follow-up)]: 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.
  • Changes in level of depression [At baseline to week 4 (after the intervention), and one month (follow-up)]: 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.
  • 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)]: 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.

+Eligibility

Sex: All, ages: 60 Years to any, accepts healthy volunteers

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

+Locations (1)

FacilityCityCountryStatus
Coastal areaKendari, Southeast SulawesiIndonesia

+Publications

  • 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 40904277

+Study documents