Frail Elderly, Prefrail Elderly
Conditions
Keywords
frailty, prefrail, teleconsultation, elderly, reversibility frailty
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
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.
Interventions
BEHAVIORALstructured teleconsultation and face to face consultation
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.
BEHAVIORALface to face consultation
Routine face-to-face outpatient visits to the geriatric clinic at weeks 1, 5, 9, 13, post-discharge, without additional telehealth consultation.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Frailty Scale (CFS) Score | 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. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health Behavior | Baseline and Week 13 post-discharge | 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. |
| Change in Serum Albumin Level | Baseline and Week 13 post-discharge | Change in serum albumin level as a nutritional biomarker associated with frailty reversibility, following structured telehealth consultation. |
| Change in Serum Myostatin Level | 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. |
| Change in Hand Grip Strength | 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. |
| Change in IL-6 | Baseline and Week 13 post-discharge | Change in IL-6 following structured telehealth consultation. |
Countries
Indonesia
Contacts
CONTACTArya Govinda Roosheroe, MD
Outcome results
None listed