NCT07712276

Brief Summary

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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

August 3, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

July 14, 2026

Last Update Submit

July 21, 2026

Conditions

Keywords

frailtyprefrailteleconsultationelderlyreversibility frailty

Outcome Measures

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.

    Baseline (at hospital discharge) and Week 13 post-discharge

Secondary Outcomes (5)

  • Change in Health Behavior

    Baseline and Week 13 post-discharge

  • Change in Serum Albumin Level

    Baseline and Week 13 post-discharge

  • Change in Serum Myostatin Level

    Baseline and Week 13 post-discharge

  • Change in Hand Grip Strength

    Baseline and Week 13 post-discharge

  • Change in IL-6

    Baseline and Week 13 post-discharge

Study Arms (2)

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.

Behavioral: structured teleconsultation and face to face consultation

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.

Behavioral: face to face consultation

Interventions

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.

Teleconsultation group

Routine face-to-face outpatient visits to the geriatric clinic at weeks 1, 5, 9, 13, post-discharge, without additional telehealth consultation.

face to face consultation group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta, Central Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Arya Govinda Roosheroe, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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 consultation vs. standard face-to-face care only), blinding of participants and care providers was not feasible.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start (Estimated)

August 3, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations