Healthy Ageing: a Feasibility Study to Evaluate Digitally-enabled Ways to Support Healthy Ageing

NCT07112352 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 7596188
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if it is feasibility to conduct a trial of two digitally-enabled interventions that support older adults to adopt healthy behaviours. It will also learn about the safety of this digital intervention. The main questions it aims to answer are

• 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

Conditions

Frailty; Older Adults (65 Years and Older); Digital Health Intervention; Feasibility Studies

Keywords

digital health intervention; frailty; older adults (65 years and older); Feasibility study; healthy habit

Outcome Measures

Primary Outcomes (2)

• Adherence (%)

  This is assessed as a percentage by comparing the number of days the intervention platform is used versus the total number of days enrolled on the study. This will be assessed among participants in Arms A and B.

  6 months

• Triage effectiveness (%)

  Triage effectiveness will be evaluated as a percentage by comparing the number of participants that are pre-frail at at first clinical assessment on Fried Frailty assessment versus total participant population. Fried Frialty is assessed using 5 frailty characteristics and is measured on a scale of 0 (best possible score) to 5 (worst possible score). Pre-frail is defined as a score of 1 or 2.

  6 months

Secondary Outcomes (32)

• Recruitment rate (%)

  6 months

• Recruitment diversity (%)

  6 months

• Changes in inflammatory blood markers (C-creative protein)

  6 months

• Changes in inflammatory markers (Interleukin-1 level)

  6 months

• Changes in inflammatory blood level (cortisol levels)

  6 months

Study Arms (3)

Control

OTHER

Standard care using National Health Service (NHS) guidance on Healthy Ageing for older adults for 6 months.

Other: Control

Smart devices with Personalised data feedback and habit coaching

EXPERIMENTAL

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.

Combination Product: Smart devices with Personalised data feedback and habit coaching

Smart devices with data feedback

ACTIVE COMPARATOR

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.

Device: Smart devices with data feedback

Interventions

Smart devices with Personalised data feedback and habit coaching COMBINATION_PRODUCT

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 Personalised data feedback and habit coaching

Smart devices with data feedback DEVICE

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

Control OTHER

Standard care where they will be signposted to National Health Service (NHS) guidance on Healthy Ageing for older adults.

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Older adults (age ≥65)
• 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

You may not qualify if:

• Adults less than 65 years old
• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Helix Centre, Institute of Global Health Innovation, Department of Surgery and Cancer, Imperial College London

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leila Shepherd, MEng, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 8, 2025
• Study Start: July 28, 2025
• Primary Completion: March 26, 2026
• Study Completion: April 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)