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

Официальное название

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

Обзор

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.

Вмешательства

• Другое Nurse-led WiSE intervention group
  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 Fatigu

Первичные конечные точки

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

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Coastal area — Kendari

Публикации

• 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

Идентификаторы

NCT: NCT07751458 · HaluOleoU · C2F

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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