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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Change in Clinical Frailty Scale (CFS) Score
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 years or older
- •Approved for hospital discharge
- •Diagnosed with pre-frailty or frailty
- •Access to a mobile phone, tablet, or laptop
排除标准
- •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
研究组 & 干预措施
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.
干预措施: face to face consultation (Behavioral)
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.
干预措施: structured teleconsultation and face to face consultation (Behavioral)
结局指标
主要结局
Change in Clinical Frailty Scale (CFS) Score
时间窗: 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.
次要结局
- 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)
- Change in Health Behavior(Baseline and Week 13 post-discharge)
研究者
Arya Govinda Roosheroe
MD
Indonesia University
