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NCT Number: NCT07751458

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

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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Key information

Conditions

Loneliness Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coastal area

Kendari, Southeast Sulawesi, 93232, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Changes in Insomnia Severity

    Time frame: 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.

  2. Changes in Epworth Sleepiness

    Time frame: 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.

  3. Changes in Sleep parameters from sleep logs

    Time frame: 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

  1. Changes in level of Anxiety

    Time frame: 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.

  2. Changes in level of depression

    Time frame: 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.

  3. Changes in level of fatigue in a person - both in terms of intensity and its impact on daily activities

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sri Susanty, PhD

CONTACT

[email protected]

6281341620632

Sponsors and collaborators

Lead sponsor

Halu Oleo University

Other

Collaborators

  • Chulalongkorn University

Registry information

Official study title

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

Acronym: WISE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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