- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07490847
Telehealth-Supported Discharge Programme for Frail Older Adults
Telehealth-Supported Discharge Programme on Health Outcomes Among Frail Older Adults: A Pilot Randomized Controlled Trial
This pilot clinical trial aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a telehealth-supported discharge programme on physical and mental health outcomes, and healthcare utilization among community-dwelling older adults with frailty after hospital discharge.
The objectives are:
- To determine the feasibility and acceptability of the programme by assessing participant recruitment, retention, adherence rates, and satisfaction;
- To evaluate the preliminary effects of the programme on a) physical health outcomes (e.g., physical fitness, activities of daily living), b) mental health outcomes (e.g., depressive symptoms, perceived social support, quality of life, subjective well-being), and c) healthcare utilization (e.g., emergency department visits, hospital readmissions); and
- To identify perceived barriers and facilitators of the programme and evaluate the acceptability and usability of gerontechnology activity sensors and pedometers for monitoring activity levels.
Community-dwelling older adults 65 years with frailty (N=50) will be recruited through a local hospital. Participants will be randomized to either the intervention or control group. The 12-week telehealth discharge support programme consists of weekly reablement-focused sessions integrating gerontechnology activity sensors and pedometers to enhance physical and mental health outcomes. Both groups will continue to receive usual care.
Descriptive statistics will be used to summarize participant data. Effect sizes will be calculated to estimate the effects of the intervention on the outcomes. Qualitative data will be analyzed using thematic analysis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Frailty is one of the most common geriatric syndromes among older adults, and manifests as three or more of these symptoms: weight loss, fatigue, weakness, slow walking speed (<1.0m/s), and low physical activity. Characterized by multisystem physiological decline, frail older adults are at an increased risk for illnesses and poor psychosocial well-being.
Older adults with frailty are also more susceptible to hospitalization and adverse outcomes following discharge. Known as the "critical period" after hospital discharge, these individuals are at risk for unplanned emergency department visits and hospital readmissions. Further, frail older adults often experience prolonged recovery periods following hospital discharge, and may also be more sedentary, which can lead to further functional decline.
Existing evidence emphasize the need for tailored interventions to support frail older adults and address their complex, multifaceted physical and mental health needs during their transition from hospital to home. This pilot study addresses gaps in the literature by introducing a structured telehealth discharge support programme tailored to community-dwelling older adults with frailty to improve physical and mental health outcomes, reduce healthcare utilization, and enhance self-management and functional recovery. To facilitate innovation in transitional care, the programme incorporates remote health monitoring tools such as home-based gerontechnology (e.g., activity sensors) and pedometers to support physical activity and recovery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah Xiao
- Phone Number: +852 3943 1502
- Email: sarahxiao@cuhk.edu.hk
Study Locations
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New Territories
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Shatin, New Territories, Hong Kong
- The Chinese University of Hong Kong
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Contact:
- Sarah Xiao
- Phone Number: +852 3943 1502
- Email: sarahxiao@cuhk.edu.hk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 65 years or older;
- Able to speak Cantonese;
- Meet the operational definition of frailty, which is defined as an individual who scores 3 or more on the 5-item FRAIL scale, which reflects fatigue, resistance, ambulation, illnesses, and weight loss;
- Are mentally competent according to the Abbreviated Mental Test (AMT ≥ 6);
- Discharged from an acute hospital within the last two weeks and residing at home; and
- Have access to a digital device with internet connectivity, such as a smartphone, tablet, or computer
Exclusion Criteria:
- Currently undergoing active psychiatric treatment for severe mental illness (e.g., schizophrenia, bipolar disorder) that result in serious functional impairment
- Experiencing medical conditions that contraindicate physical exercise (e.g., recent acute myocardial infarction, unstable cardiovascular pathology, fracture within the past month); and/or
- Presenting with any significant visual, language, or communication impairments that would impede their ability to meaningfully engage with the programme
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 |
|---|---|
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Experimental: Telehealth discharge support programme
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The 12-week telehealth-supported discharge programme consists of weekly one hour virtual sessions consisting of didactic and experiential activities to support recovery after hospital discharge. Sessions focus on improving physical activity and mobility through home-based exercises, strengthening self-management skills related to frailty, promoting mental resilience and well-being, and providing opportunities for peer interaction and social support. Additionally, one activity sensor will be installed in the homes of participants within the intervention group to monitor and evaluate their physical activity levels and patterns over time. The advanced smart home activity sensors, equipped with AI capabilities, will enable remote monitoring of daily activity patterns among participants. A pedometer will also be provided to participants as a motivational tool to reduce sedentary behaviour. |
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No Intervention: Usual care
Participants assigned to the control group will continue to receive usual care.
Usual care typically includes home visits and/or follow-up calls by community nurses focused on medication management and basic health education, as needed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical fitness
Time Frame: Baseline (T0) and upon intervention completion at 12 weeks (T1)
|
Physical fitness will be assessed using the Senior Fitness Test (SFT), which is comprised of seven tests that evaluate body strength, flexibility, agility, aerobic capacity, and body composition.
The tests include the following: 30-second chair stand, 30-second arm curl, 2-minute step test, chair sit-and-reach, back scratch, 8-foot-up-and-go, and 2-minute step-in-place test.
Each component is scored separately using standardized units (e.g., number of repetitions, distance, or time), with higher scores generally indicating better physical fitness, except for timed tests (e.g., 8-foot up-and-go), where lower times indicate better performance.
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Baseline (T0) and upon intervention completion at 12 weeks (T1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Activities of daily living
Time Frame: Baseline (T0) and upon intervention completion at 12 weeks (T1)
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Functional independence will be evaluated using the Katz Index of Independence in Activities of Daily Living (ADL).
The Katz Index of Independence in ADL is a 6-item tool that assesses basic self-care abilities, such as feeding, bathing, dressing, transferring, toileting, and mobility.
Total scores range from 0 to 6, with higher scores indicating greater independence in self-care activities.
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Baseline (T0) and upon intervention completion at 12 weeks (T1)
|
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Instrumental activities of daily living
Time Frame: Baseline (T0) and upon intervention completion at 12 weeks (T1)
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Functional independence will also be evaluated using the Lawton Instrumental Activities of Daily Living (IADL) Scale.
The Lawton IADL Scale consists of 8 items that evaluate complex activities for independent living, such as preparing meals, handling finances, using transportation, housekeeping, doing laundry, shopping, using the telephone, and taking medications.
Total scores range from 0 to 8, with higher scores indicating greater independence in instrumental activities.
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Baseline (T0) and upon intervention completion at 12 weeks (T1)
|
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Depressive symptoms
Time Frame: Baseline (T0) and upon intervention completion at 12 weeks (T1)
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Depressive symptoms will be measured by the 4-item Geriatric Depression Scale (GDS-4).
The GDS-4 consists of four dichotomous (yes/no) items, with total scores ranging from 0 to 4. Higher scores indicate greater depressive symptoms.
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Baseline (T0) and upon intervention completion at 12 weeks (T1)
|
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Perceived social support
Time Frame: Baseline (T0) and upon intervention completion at 12 weeks (T1)
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Social support will be assessed using the 10-item Duke Social Support Index (DSSI), which evaluates constructs such as social satisfaction and social interaction.
Total scores range from 0 to 30, with higher scores reflecting greater perceived levels of social support.
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Baseline (T0) and upon intervention completion at 12 weeks (T1)
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Health-related quality of life
Time Frame: Baseline (T0) and upon intervention completion at 12 weeks (T1)
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Health-related quality of life (QoL) will be assessed using the EuroQol 5 Dimension 5-Level (EQ-5D-5L) questionnaire.
The instrument aims to evaluate the following five QoL dimensions: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.
Each dimension is rated on five levels, which include no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems/unable to perform (5).
Responses can be calculated into a single index score, typically ranging from less than 0 (worse than death) to 1 (full health), with higher scores indicating better health-related QoL.
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Baseline (T0) and upon intervention completion at 12 weeks (T1)
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Subjective well-being
Time Frame: Baseline (T0) and upon intervention completion at 12 weeks (T1)
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Subjective well-being will be measured using the 5-item WHO Well-being Index, which assesses mental well-being over the past two weeks.
The scale is comprised of five positively worded items rated on a 6-point Likert scale, yielding a total score ranging from 0 to 25.
Higher scores indicate greater subjective well-being, with a cutoff below 13 suggesting poor well-being.
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Baseline (T0) and upon intervention completion at 12 weeks (T1)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital readmissions
Time Frame: Upon intervention completion at 12 weeks (T1)
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Participants will provide self-reported data on the use of inpatient hospital services from the Client Service Receipt Inventory (CRSI).
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Upon intervention completion at 12 weeks (T1)
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Unplanned visits to the emergency department
Time Frame: Upon intervention completion at 12 weeks (T1)
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Participants will provide self-reported data on the use of inpatient hospital services from the CRSI.
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Upon intervention completion at 12 weeks (T1)
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Hospital length of stay
Time Frame: Upon intervention completion at 12 weeks (T1)
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Participants will provide self-reported data on the use of inpatient hospital services from the CRSI.
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Upon intervention completion at 12 weeks (T1)
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Collaborators and Investigators
Sponsor
Collaborators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIRB-2025-552-5
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.
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