NCT Number: NCT07712276
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
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
Jakarta, Central Jakarta, 10430, Indonesia
Arya Govinda Roosheroe, MD
CONTACT
Arya Govinda Roosheroe, MD
PRINCIPAL_INVESTIGATOR
Edy Rizal Wachyudi, MD, PhD
SUB_INVESTIGATOR
IGP Suka Aryana, MD, PhD
SUB_INVESTIGATOR
Kuntjoro Harimurti, MD, PhD
SUB_INVESTIGATOR
Melinda Harini, MD, PhD
SUB_INVESTIGATOR
Nurul Ratna Mutu Manikam, MD, PhD
SUB_INVESTIGATOR
Siti Setiati, Prof, MD, PhD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Routine face-to-face outpatient visits to the geriatric clinic at weeks 1, 5, 9, 13, post-discharge, without additional telehealth consultation.
Time frame: Baseline (at hospital discharge) and Week 13 post-discharge
Frailty reversibility assessed as the change in Clinical Frailty Scale (CFS) score from baseline (pre-intervention, at hospital discharge) to post-intervention, following structured telehealth consultation based on physical exercise, nutrition, and home care education aimed at health behavior change. The Clinical Frailty Scale is a 9-point clinical assessment tool used to evaluate frailty status in older adults. Scores range from 1 to 9, where 1 indicates very fit, 2 indicates Fit, 3 indicates Managing Well, 4 indicates Living with Very Mild Frailty, 5 indicates Living with Mild Frailty, 6 indicates Living with Moderate Frailty, 7 indicates Living with Severe Frailty, 8 indicates Living with Very Severe Frailty, and 9 indicates terminally ill. Higher scores indicate greater frailty and therefore a worse clinical outcome.
Time frame: Baseline and Week 13 post-discharge
Change in health-related behaviors (physical exercise, nutrition, and medication adherence) following structured teleconsultation, assessed using a study-specific Health Behavior Questionnaire. The questionnaire consists of 5 items, each scored on a 5-point Likert scale (1-5), with a total score ranging from 5 to 25. Higher scores indicate better health-related health behaviors.
Time frame: Baseline and Week 13 post-discharge
Change in serum albumin level as a nutritional biomarker associated with frailty reversibility, following structured telehealth consultation.
Time frame: Baseline and Week 13 post-discharge
Change in serum myostatin level as a biomarker of muscle wasting associated with frailty reversibility, following structured telehealth consultation.
Time frame: Baseline and Week 13 post-discharge
Change in hand grip strength, measured using a dynamometer, as an indicator of physical frailty component, following structured telehealth consultation.
Time frame: Baseline and Week 13 post-discharge
Change in IL-6 following structured telehealth consultation.
Contact information is provided by the study sponsor or research team.
Indonesia University
Other
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
Acronym: TeleFrailty
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