The Effect of Teleconsultation, on the Reversibility of Frailty in Geriatric Patients Post Hospitalization

Официальное название

The Effect of Structured Teleconsultation, as Part of Discharge Planning, on the Reversibility of Frailty in Geriatric Patients Post Hospitalization: a Clinical Trial Based on Clinical Scores and Biological Markers

Обзор

The goal of this clinical trial is to learn if a structured tele-consultation program, delivered 3 times over 12 weeks, can improve (reverse) frailty in geriatric patients recently discharged from the hospital. The main questions it aims to answer are: * Does structured tele-consultation covering physical exercise, nutrition, and home care education change health behavior in older adults after hospital discharge? * Does this change in health behavior lead to improvement in frailty, as measured by Clinical Frailty Scale (CFS) score? * Does this change in health behavior lead to improvement in frailty, as measured by decreased interleukin-6 (IL-6) and myostatin levels and increased albumin levels? * Does this change in health behavior lead to improvement in frailty, as measured by increased hand grip strength? Researchers will compare participants receiving structured tele-consultation (delivered 3 times over 12 weeks) to participants receiving usual care to see if tele-consultation leads to greater improvement in health behavior and frailty status. Participants will: * Undergo baseline assessment of CFS score, hand grip strength, and blood sampling for IL-6, albumin, and myostatin shortly after hospital discharge * Be randomly assigned to receive either structured tele-consultation (3 sessions over 12 weeks, covering physical exercise, nutrition, and home care education) or usual care * Undergo repeat assessment of health behavior, CFS score, hand grip strength, and the same blood markers at the end of the 12-week period

Подробное описание

Frailty is common among older adults following hospitalization and is associated with increased risk of readmission, functional decline, and mortality. Telemedicine has been proposed to support frailty management, but prior studies have used varied formats and shown inconsistent results, and no prior study has evaluated structured tele-consultation targeting physical exercise, nutrition, and home care education as a means of reversing frailty in older adults after hospital discharge, using both a validated frailty score and biological markers as outcomes.

This study is a randomized controlled trial conducted among older adults admitted to the acute geriatric ward who are deemed fit for discharge. Eligible patients are enrolled after providing informed consent, and baseline data (frailty scores, biological markers, hand grip strength) are collected prior to discharge. Participants are randomly allocated to an intervention group or a control group. Both groups receive standard discharge planning and follow-up at the geriatric outpatient clinic over a 12-week period after discharge. In addition to standard follow-up, participants in the intervention group receive structured tele-consultation sessions addressing physical exercise, nutrition, and home care education, delivered by a trained physician, dietitian, and physiotherapist. Outcome assessments are performed at baseline and at the end of the follow-up period by an assessor unaware of participants' group allocation.

Participants who are readmitted to hospital during the study period are withdrawn from the study. All collected data are kept confidential and used only for research purposes. Data from participants who withdraw or are lost to follow-up are retained and analyzed using an intention-to-treat approach.

Вмешательства

• Поведенческое structured teleconsultation and face to face consultation
  A structured teleconsultation delivered via videoconference (Zoom), up to 60 minutes per session, provided by a trained general practitioner, dietitian, and physiotherapist. Sessions were conducted with the patient and a consistent family member/caregiver at weeks 3, 7, 11 post-discharge, in addition to standard discharge planning and routine face-to-face outpatient visits at weeks 1, 5, 9, 13.
• Поведенческое face to face consultation
  Routine face-to-face outpatient visits to the geriatric clinic at weeks 1, 5, 9, 13, post-discharge, without additional telehealth consultation.

Первичные конечные точки

• Change in Clinical Frailty Scale (CFS) Score [Срок оценки: Baseline (at hospital discharge) and Week 13 post-discharge]

Вторичные конечные точки (5)

• Change in Health Behavior [Срок оценки: Baseline and Week 13 post-discharge]
• Change in Serum Albumin Level [Срок оценки: Baseline and Week 13 post-discharge]
• Change in Serum Myostatin Level [Срок оценки: Baseline and Week 13 post-discharge]
• Change in Hand Grip Strength [Срок оценки: Baseline and Week 13 post-discharge]
• Change in IL-6 [Срок оценки: Baseline and Week 13 post-discharge]

Критерии участия

Критерии включения

• Age 60 years or older
• Approved for hospital discharge
• Diagnosed with pre-frailty or frailty
• Access to a mobile phone, tablet, or laptop

Критерии исключения

• Unwilling to participate in the study
• Depression, as indicated by a Geriatric Depression Scale (GDS) score ≥10, assessed at the time of discharge
• Moderate to severe cognitive impairment, as indicated by a Montreal Cognitive Assessment-Indonesian version (MoCA-INA) score <26, assessed at the time of discharge
• Severe frailty, as indicated by a Clinical Frailty Scale (CFS) score >8
• Liver cirrhosis
• Chronic kidney disease stage 4 or higher
• Stage 4 malignancy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Cipto Mangunkusumo Hospital — Jakarta

Идентификаторы

NCT: NCT07712276 · 26-05-0746

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗