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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Arya Govinda Roosheroe, MD
- 전화번호: +62 812-9430-3863
- 이메일: argov0504@gmail.com
연구 장소
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Central Jakarta
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Jakarta, Central Jakarta, 인도네시아, 10430
- Cipto Mangunkusumo Hospital
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연락하다:
- Arya Govinda Roosheroe, MD
- 전화번호: +62 812-9430-3863
- 이메일: argov0504@gmail.com
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수석 연구원:
- Arya Govinda Roosheroe, MD
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부수사관:
- Siti Setiati, Prof, MD, PhD
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부수사관:
- Kuntjoro Harimurti, MD, PhD
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부수사관:
- Nurul Ratna Mutu Manikam, MD, PhD
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부수사관:
- Edy Rizal Wachyudi, MD, PhD
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부수사관:
- IGP Suka Aryana, MD, PhD
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부수사관:
- Melinda Harini, MD, PhD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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활성 비교기: 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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Clinical Frailty Scale (CFS) Score
기간: Baseline (at hospital discharge) and Week 13 post-discharge
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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.
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Baseline (at hospital discharge) and Week 13 post-discharge
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Serum Albumin Level
기간: Baseline and Week 13 post-discharge
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Change in serum albumin level as a nutritional biomarker associated with frailty reversibility, following structured telehealth consultation.
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Baseline and Week 13 post-discharge
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Change in Serum Myostatin Level
기간: Baseline and Week 13 post-discharge
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Change in serum myostatin level as a biomarker of muscle wasting associated with frailty reversibility, following structured telehealth consultation.
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Baseline and Week 13 post-discharge
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Change in Hand Grip Strength
기간: Baseline and Week 13 post-discharge
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Change in hand grip strength, measured using a dynamometer, as an indicator of physical frailty component, following structured telehealth consultation.
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Baseline and Week 13 post-discharge
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Change in IL-6
기간: Baseline and Week 13 post-discharge
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Change in IL-6 following structured telehealth consultation.
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Baseline and Week 13 post-discharge
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Change in Health Behavior
기간: Baseline and Week 13 post-discharge
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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.
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Baseline and Week 13 post-discharge
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 26-05-0746
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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