- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07712276
The Effect of Teleconsultation, on the Reversibility of Frailty in Geriatric Patients Post Hospitalization (TeleFrailty)
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
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
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arya Govinda Roosheroe, MD
- Phone Number: +62 812-9430-3863
- Email: argov0504@gmail.com
Study Locations
-
-
Central Jakarta
-
Jakarta, Central Jakarta, Indonesia, 10430
- Cipto Mangumkusumo Hospital
-
Contact:
- Arya Govinda Roosheroe, MD
- Phone Number: +62 812-9430-3863
- Email: argov0504@gmail.com
-
Principal Investigator:
- Arya Govinda Roosheroe, MD
-
Sub-Investigator:
- Siti Setiati, Prof, MD, PhD
-
Sub-Investigator:
- Kuntjoro Harimurti, MD, PhD
-
Sub-Investigator:
- Edy Rizal Wachyudi, MD< PhD
-
Sub-Investigator:
- IGP Suka Aryana, MD< PhD
-
Sub-Investigator:
- Nurul Ratna Mutu Manikam, MD, PhD
-
Sub-Investigator:
- Melinda Harini, MD< PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 60 years or older
- Approved for hospital discharge
- Diagnosed with pre-frailty or frailty
- Access to a mobile phone, tablet, or laptop
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Teleconsultation group
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.
|
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.
|
|
Active Comparator: face to face consultation group
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.
|
Routine face-to-face outpatient visits to the geriatric clinic at weeks 1, 5, 9, 13, post-discharge, without additional telehealth consultation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Clinical Frailty Scale (CFS) Score
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.
|
Baseline (at hospital discharge) and Week 13 post-discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Health Behavior
Time Frame: Baseline and Week 13 post-discharge
|
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
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.
|
Baseline and Week 13 post-discharge
|
|
Change in Serum Myostatin Level
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.
|
Baseline and Week 13 post-discharge
|
|
Change in Hand Grip Strength
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.
|
Baseline and Week 13 post-discharge
|
|
Change in IL-6
Time Frame: Baseline and Week 13 post-discharge
|
Change in IL-6 following structured telehealth consultation.
|
Baseline and Week 13 post-discharge
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26-05-0746
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Frail Elderly
-
DSM Nutritional Products, Inc.CompletedFrail Elderly | Pre-frail ElderlyNetherlands
-
Maimonides Medical CenterCompletedElderly | Frail Elderly | Hospitalization | Geriatrics
-
Aalborg University HospitalUniversity of Copenhagen; Hvidovre University Hospital; Amager Hospital; Aalborg...Completed
-
University of SalamancaExcelentísimo Ayuntamiento de SalamancaCompleted
-
University of ManitobaTerminated
-
McMaster UniversityCanadian Frailty NetworkCompleted
-
Health Center of the City of JoensuuUnknown
-
Marmara UniversityEnrolling by invitationFrail ElderlyTurkey (Türkiye)
Clinical Trials on structured teleconsultation and face to face consultation
-
Hospices Civils de LyonRecruiting
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingFunctional Dyspepsia | Irritable Bowel Syndrome (IBS) | Abdominal Migraine | Functional Abdominal Pain DisordersNetherlands
-
OncoHelp AssociationNot yet recruiting
-
Hospital Israelita Albert EinsteinUnknown
-
NHS LothianUniversity of EdinburghTerminatedAbortion in First Trimester | Abortion EarlyUnited Kingdom
-
Hospital Israelita Albert EinsteinCompletedRespiratory Tract InfectionsBrazil
-
University of Sao Paulo General HospitalCompleted
-
The Hong Kong Polytechnic UniversityTuen Mun HospitalCompletedDiabetes MellitusHong Kong
-
The Hong Kong Polytechnic UniversityThe Queen Elizabeth HospitalRecruiting
-
Radboud University Medical CenterUnknown