NCT07751458

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

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jul 2026Dec 2026

First Submitted

Initial submission to the registry

December 3, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

July 30, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2026

Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

December 3, 2025

Last Update Submit

August 5, 2026

Conditions

Keywords

WiSEOlder adultsLonelinessInsomnia

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

EXPERIMENTAL

Behavioral: 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.

Other: Nurse-led WiSE intervention group

Control Group

NO INTERVENTION

Participants 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.

Nurse-led WISE intervention group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Coastal area

Kendari, Southeast Sulawesi, 93232, Indonesia

Location

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

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Sri Susanty, PhD

CONTACT

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

Locations