Healthy Ageing: a Feasibility Study to Evaluate Digitally-enabled Ways to Support Healthy Ageing
NCT ID: NCT07112352
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-07-28
2026-10-31
Brief Summary
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* How acceptable and feasible are the trial, intervention and control groups in assessing outcomes
* What is the estimated effect of the interventions? Researchers will compare Smart devices with a bespoke 'Healthy Habits' application and three healthy habit coaching and data feedback modules, to a group with smart devices and standard off-the-shelf feedback application, to a control group that will receive an education leaflet to adopt healthy behaviours.
Participants will:
* Use sensors and the 'Healthy Habits' application for 3 months followed by standard application for 3 months, or sensors and standard application for 6 months, or control
* Either home visit or in-centre visit once every 3 months for assessments and online health questionnaires
* Complete daily diary of any healthcare use
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Detailed Description
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This is a three-arm parallel group non-blinded randomised feasibility trial which involves community-dwelling older adults who are 65 years old and above who are pre-frail as defined by Fried Frailty. Participants are recruited from the community setting.
Potential participants are invited to complete an eligibility questionnaire and screened for eligibility. If eligible, they are consented to participate in the study for six months. On receipt of their consent form, they are randomised into three groups. The groups are A: smart devices with personalised data feedback and habit coaching, B: smart devices with data feedback and a Control group with standard care. Group A will use Smart devices (smartwatch and sleep mat) with a bespoke 'Healthy Habits' application and four healthy habit coaching and data feedback modules focused on active minutes, steps and sedentary time, viewable on a tablet. These modules were co-designed and chosen with participants during a previous Design and Feasibility study. At the end of three months, the application is uninstalled and participants continue to use their smart devices with data feedback.
Participants randomised to Group B will use smart devices (smartwatch and sleep mat) with standard off-the-shelf data feedback application ("WithingsTM App") providing generalised data feedback from the participant's smartwatch and sleep mat, viewable on a tablet for 6 months. Participants randomised to the control group will receive standard care where they will be signposted to the NHS guidance on Healthy Ageing for older adults for six months. Participants will undertake baseline, three and six months online and in-person health assessments and blood test. Participants in Groups A and B will be for feedback about their experience of the programme.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control
Standard care using National Health Service (NHS) guidance on Healthy Ageing for older adults for 6 months.
Control
Standard care where they will be signposted to National Health Service (NHS) guidance on Healthy Ageing for older adults.
Smart devices with Personalised data feedback and habit coaching
Participants use smart devices (smartwatch and sleep mat) with a bespoke 'Healthy Habits' application with three healthy habit coaching and data feedback modules focused on active minutes, steps and sedentary time, viewable on a tablet for 3 months. The 'Healthy Habits' application is uninstalled after 3 months and participants will be taught how to use standard 'Withings' application to view their data.
Smart devices with Personalised data feedback and habit coaching
Smart devices (smartwatch and sleep mat) with a bespoke 'Healthy Habits' application with three healthy habit coaching and data feedback modules, focused on active minutes, steps and sedentary time, viewable on a tablet.
Smart devices with data feedback
Smart devices (smartwatch and sleep mat) with a standard off-the-shelf data feedback application ("WithingsTM App") providing generalised data feedback from the participant's smartwatch and sleep mat, viewable on a tablet for 6 months.
Smart devices with data feedback
Smart devices (smartwatch and sleep mat) with a standard off-the-shelf data feedback application ("WithingsTM App") providing generalised data feedback from the participant's smartwatch and sleep mat, viewable on a tablet for 6 months.
Interventions
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Smart devices with Personalised data feedback and habit coaching
Smart devices (smartwatch and sleep mat) with a bespoke 'Healthy Habits' application with three healthy habit coaching and data feedback modules, focused on active minutes, steps and sedentary time, viewable on a tablet.
Smart devices with data feedback
Smart devices (smartwatch and sleep mat) with a standard off-the-shelf data feedback application ("WithingsTM App") providing generalised data feedback from the participant's smartwatch and sleep mat, viewable on a tablet for 6 months.
Control
Standard care where they will be signposted to National Health Service (NHS) guidance on Healthy Ageing for older adults.
Eligibility Criteria
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Inclusion Criteria
* Community-dwelling Adults living at home
* Living within the London boroughs
* Willing to engage in an exercise programme
* On at least one medication
* Pre-frail on Edmonton-AC and/or FRAIL and PRISMA \< 3
* Clinically assessed to have Fried 1-3 (this is completed at baseline assessment)
* Has the capacity to provide informed consent
* Able to speak and understand written English
Exclusion Criteria
* Living outside the London boroughs
* Living in a nursing home or hospitalised or hospice
* Not taking any medication (indicating robust frailty status)
* Significant cognitive impairment due to concerns that cognitive impairment and its causes presents different barriers to engagement and participation with sensors and intervention
* Individuals with severe limitations in activities of daily living which would prevent active participation in the assessments, interfere with participation in the physical exercise programme
* Being unable to safely engage in the exercise component for other health-related reasons such as Musculoskeletal or neurological disorders that impair gait speed and balance as these are key outcome metrics
* Progressive or severe medical illness e.g. acute myocardial infarction in the last 3 months, unstable angina, severe aortic stenosis, uncontrolled orthostatic hypotension, recent bone fracture in the last 3 months, having a life expectancy of less than 24 months, requiring palliative care within the following two years, three or more hospitalisations in the last year
* Moderate - Severe Depression, Psychiatric disorders which may interfere with their participation in the study
* Being treated for active cancer
* Unstable medical conditions or where clinical optimisation required e.g. uncontrolled diabetes.
* Participating in other clinical studies
* Unable to participate for 6 months in the study (with 28 days allowed to be away from home)
* Unable to speak or understand written English
65 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Leila Shepherd, MEng, PhD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Helix Centre, Institute of Global Health Innovation, Department of Surgery and Cancer, Imperial College London
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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7596188
Identifier Type: -
Identifier Source: org_study_id
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