The Effect of Teleconsultation, on the Reversibility of Frailty in Geriatric Patients Post Hospitalization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorIndonesia University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 60 years or older
Approved for hospital discharge
Diagnosed with pre-frailty or frailty
Access to a mobile phone, tablet, or laptop
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
structured teleconsultation and face to face consultation
BehavioralA 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.
face to face consultation
BehavioralRoutine face-to-face outpatient visits to the geriatric clinic at weeks 1, 5, 9, 13, post-discharge, without additional telehealth consultation.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Teleconsultation groupExperimental treatment 1 intervention
Group B: face to face consultation groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Clinical Frailty Scale (CFS) Score
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 (at hospital discharge) and Week 13 post-dischargeSecondary outcomes
1
Change in Health Behavior
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-discharge2
Change in Serum Albumin Level
Change in serum albumin level as a nutritional biomarker associated with frailty reversibility, following structured telehealth consultation.
Time frame
Baseline and Week 13 post-discharge3
Change in Serum Myostatin Level
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-discharge4
Change in Hand Grip Strength
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-dischargeSponsors and contacts
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Source ClinicalTrials.gov
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