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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Arya Govinda Roosheroe, MD
- Numero di telefono: +62 812-9430-3863
- Email: argov0504@gmail.com
Luoghi di studio
-
-
Central Jakarta
-
Jakarta, Central Jakarta, Indonesia, 10430
- Cipto Mangumkusumo Hospital
-
Contatto:
- Arya Govinda Roosheroe, MD
- Numero di telefono: +62 812-9430-3863
- Email: argov0504@gmail.com
-
Investigatore principale:
- Arya Govinda Roosheroe, MD
-
Sub-investigatore:
- Siti Setiati, Prof, MD, PhD
-
Sub-investigatore:
- Kuntjoro Harimurti, MD, PhD
-
Sub-investigatore:
- Edy Rizal Wachyudi, MD< PhD
-
Sub-investigatore:
- IGP Suka Aryana, MD< PhD
-
Sub-investigatore:
- Nurul Ratna Mutu Manikam, MD, PhD
-
Sub-investigatore:
- Melinda Harini, MD< PhD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Clinical Frailty Scale (CFS) Score
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Health Behavior
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline and Week 13 post-discharge
|
Change in IL-6 following structured telehealth consultation.
|
Baseline and Week 13 post-discharge
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 26-05-0746
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su structured teleconsultation and face to face consultation
-
IRCCS Centro San Giovanni di Dio FatebenefratelliIRCCS San Raffaele; Fondazione Don Carlo Gnocchi Onlus; IRCCS Centro Neurolesi...Completato
-
Mayo ClinicCompletato