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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:
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:
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Participants who are readmitted to hospital during the study period are withdrawn from the study.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teleconsultation group | Experimental | Participants received standard discharge planning and standard face-to-face outpatient visits (consultation) at weeks 1, 5, 9, 13 post-discharge, plus structured teleconsultation (via Zoom, up to 60 minutes) conducted by a trained general practitioner, dietitian, and physiotherapist at weeks 3, 7, 11, post-discharge. |
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| face to face consultation group | Active Comparator | Participants received standard discharge planning and standard face-to-face outpatient visits (consultation) only, at weeks 1, 5, 9, 13 post-discharge, without additional teleconsultation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| structured teleconsultation and face to face consultation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (at hospital discharge) and Week 13 post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Health Behavior | Change in health-related behavior (physical exercise, nutrition, and home care practices) following structured teleconsultation, assessed using validated behavioral questionaire | Baseline and Week 13 post-discharge |
| Change in Serum Albumin Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arya Govinda Roosheroe, MD | Contact | +62 812-9430-3863 | argov0504@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangumkusumo Hospital | Jakarta | Central Jakarta | 10430 | Indonesia |
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Eligible participants were randomly allocated in a 1:1 ratio to either the intervention group (structured telehealth consultation in addition to standard face-to-face outpatient visits) or the control group (standard face-to-face outpatient visits only), both following standard discharge planning. Randomization was performed using computer-generated block permuted randomization with a block size of 4. Allocation was concealed using sealed opaque envelopes. Outcome data (health behaviour, frailty status, IL-6, albumin, myostatin, and hand grip strength) were collected by a blind assessor unaware of participants' group allocation, at baseline (pre-intervention) and at week 13 post-discharge (post-intervention)
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Outcome assessors responsible for collecting pre- and post-intervention data (frailty scores, biomarkers, and hand grip strength) were kept unaware of participants' group allocation. Due to the nature of the intervention (teleconsultation and face to face cnsultation vs. standard face-to-face care only), blinding of participants and care providers was not feasible.
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| face to face concultation | Behavioral | Routine face-to-face outpatient visits to the geriatric clinic at weeks 1, 5, 9, 13, post-discharge, without additional telehealth consultation. |
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Change in serum albumin level as a nutritional biomarker associated with frailty reversibility, following structured telehealth consultation. |
| Baseline and Week 13 post-discharge |
| Change in Serum Myostatin Level | Change in serum myostatin level as a biomarker of muscle wasting associated with frailty reversibility, following structured telehealth consultation. | Baseline and Week 13 post-discharge |
| 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. | Baseline and Week 13 post-discharge |
| Change in IL-6 | Change in IL-6 following structured telehealth consultation. | Baseline and Week 13 post-discharge |
| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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