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LonelinessWISENCT07751458

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

A study testing Nurse-led WiSE intervention group in people with Loneliness and Insomnia, run by Halu Oleo University at 1 site in Indonesia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Loneliness, Insomnia
What is being tested?
Nurse-led WiSE intervention group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIndonesia
Study dates
30 Jul 2026to 3 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sri Susanty, PhD contact

6281341620632

sri.susanty@uho.ac.id

Indonesia1 site

  • Coastal area

    Kendari, Southeast Sulawesi, 93232

Other trials in Indonesia

About this study

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

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.

Conditions
Loneliness, Insomnia
Being tested
Nurse-led WiSE intervention group
Keywords
WiSE, Older adults, Loneliness, Insomnia
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nurse-led WiSE intervention groupOther

    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.

Study groups in NCT07751458
Study groupRoleWhat they receive
Nurse-led WISE intervention groupExperimentalBehavioral: 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.
Receives: Other: Nurse-led WiSE intervention group
Control GroupNo interventionParticipants received no education or treatment for 4 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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

    Measured: At baseline to week 4 (after the intervention), and one month (follow-up)

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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.

    Measured: At baseline to week 4 (after the intervention), and one month (follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2026
  2. Study start30 Jul 2026 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion3 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07751458
Sponsor's protocol ID
HaluOleoU
Other IDs
C2F
Acronym
WISE
Status last verified
Aug 2026
First submitted
3 Dec 2025
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 40904277

Questions about this trial

What is this clinical trial studying?

A study testing Nurse-led WiSE intervention group in people with Loneliness and Insomnia, run by Halu Oleo University at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sri Susanty, PhD (6281341620632, sri.susanty@uho.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Insomnia Severity (time frame: At baseline to week 4 (after the intervention), and one month (follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07751458, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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