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FrailtyPhase 2NCT07112352

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

A Phase 2 study testing Smart devices with Personalised data feedback and habit coaching and Smart devices with data feedback in people with Frailty and Older Adults (65 Years and Older), run by Imperial College London at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Smart devices with Personalised data feedback and habit coaching and Smart devices with data feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited Kingdom
Study dates
28 Jul 2025to Apr 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • • 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
Show all 9Show fewer
  • 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

Who cannot join

  • • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Helix Centre, Institute of Global Health Innovation, Department of Surgery and Cancer, Imperial College London

    London, W2 1NY

Other trials in United Kingdom

About this study

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.
Read more

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
Read the detailed description

Frailty is defined as a clinical state manifesting in a reduced capacity to tolerate physiological stressors. This is associated with increased usage of healthcare, healthcare costs and reduced quality of life. This study aims to assess the feasibility of conducting a definitive trial comparing two digitally-enabled interventions that support older adults to adopt healthy behaviours compared to a control. Feasibility will be broken down into trial, intervention and control feasibility. The secondary objectives are preliminary estimation of effect size from the interventions and observation of any persistence effect.

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.

Being tested
Smart devices with Personalised data feedback and habit coaching, Smart devices with data feedback, Control
Keywords
digital health intervention, frailty, older adults (65 years and older), Feasibility study, healthy habit
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smart devices with Personalised data feedback and habit coachingCombination 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 data feedbackDevice

    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.

  • ControlOther

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

Study groups in NCT07112352
Study groupRoleWhat they receive
ControlOtherStandard care using National Health Service (NHS) guidance on Healthy Ageing for older adults for 6 months.
Receives: Other: Control
Smart devices with Personalised data feedback and habit coachingExperimentalParticipants 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.
Receives: Combination Product: Smart devices with Personalised data feedback and habit coaching
Smart devices with data feedbackActive comparatorSmart 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.
Receives: Device: Smart devices with data feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

Secondary outcomes (32)
  1. Recruitment rate (%)

    Recruitment rate will be assessed by comparing the number of people enrolled and consented to the study compared to number of people invited stratified by each recruitment channel used.

    Measured: 6 months

  2. Recruitment diversity (%)

    This is assessed by comparing the number of participants from different demographic groups stratified by ethnicity and gender as compared to participant population.

    Measured: 6 months

  3. Changes in inflammatory blood markers (C-creative protein)

    Blood samples will be collected to evaluate changes in inflammatory marker in the form of C-Reactive Protein (in mg/mL). The levels at baseline will be compared to samples at 3-month and 6-month assessments.

    Measured: 6 months

  4. Changes in inflammatory markers (Interleukin-1 level)

    Blood samples are collected to evaluate changes in interleukins-1 (in pg/mL). The levels at baseline will be compared to blood samples taken at three and six-month assesssments.

    Measured: 6 months

  5. Changes in inflammatory blood level (cortisol levels)

    Blood samples will also be collected to evaluate changes in inflammatory markers. This is measured using cortisol (in pg/mL) where baseline levels will be compared to blood samples taken at three and six months assessments.

    Measured: 6 months

  6. Completeness of online triage surveys (%)

    Online surveys are sent to participants at triage, baseline, three and six months of the study. Completeness of online triage surveys (in percentage) is assessed by comparing the number of completed triage surveys versus total triage surveys started by participants to understand the acceptability of triage procedure.

    Measured: 6 months

  7. Safety of intervention and control groups

    This is monitored using a Hazard Log of adverse and serious adverse incidents throughout the study. This outcome is assessed by evaluating the number of adverse and serious adverse events in all 3 groups.

    Measured: 6 months

  8. Acceptability of control group

    This is measured through qualitative feedback on acceptability of the assessments, information and support provided to participants in the control group collected through verbal and free-text responses at three and six-month visits. These responses will be thematically analysed.

    Measured: 6 months

  9. Acceptability of intervention using System Usability Scale - SUS

    The acceptability of interventions Arms A and B will be assessed using System Usability Score (SUS). The SUS is a ten-item attitude Likert scale giving a global view of subjective assessments of usability. Scores range from 0 (the worst possible score) to 100 (the best possible score). This is evaluated at three and six months of the intervention.

    Measured: 6 months

  10. Acceptability of intervention using Unified Theory of Acceptance and Use of Technology

    The acceptability of interventions Arms A and B will be assessed using modified Unified Theory of Acceptance and Use of Technology (UTAUT). Modified UTAUT has 25 components each measured on likert scale of 1 being strongly disagree and 5 being strongly agree. This is a range of 25 (worst possible score) to 125 (best possible score). This is assessed at three and six month feedback surveys

    Measured: 6 months

  11. Changes in weight (in kg)

    Using Withings Smartscale, weight (in kilograms) at three and six months will be compared to baseline assessment.

    Measured: 6 months

  12. Changes in Fried Frailty Score

    This will be assessed by comparing Fried Frailty Score at 3 and 6 month assessments compared to score at baseline assessment. Fried Frialty is assesses the presence of five frailty characteristics and is measured on a scale of 0 (best possible score) to 5 (worst possible score).

    Measured: 6 months

  13. Changes in sleep (Total Sleep Duration)

    This is assessed using Withings Sleepmat for changes in total sleep duration (in hours per day) among participants in Arm A and B. The total sleep duration at 6 months will be compared to baseline period of first 7 days of the study.

    Measured: 6 months

  14. Change in sedantary time (in minutes)

    Changes in sedentary time (in minutes per day) is measured through a smartwatch. This is assessed by comparing the average daily sedentary time at 3 and 6-months as compared to baseline assessment.

    Measured: 6 months

  15. Changes in activity levels (number of active minutes)

    This will be assessed by comparing average daily active minutes at 3 and 6 months versy average daily active minutes in baseline period. This is measured in active minutes per day as measured by Withings Smartwatch.

    Measured: 6 months

  16. Change in Short physical performance battery

    This will be assessed by comparing three and six-month scores of Short Physical Performance Battery versus their baseline assessment score. This is measured using three physical tests in units on a scale of 0 (lowest worst score) to 12 (highest best score).

    Measured: 6 months

  17. Change in Gait speed (%)

    This will be assessed by comparing percentage change in three and six-month assessment of Gait speed (in metres per second) as compared to baseline assessment. Normal walking speed is measured by measuring the time (in seconds) participants take to complete a distance of 15 feet (4.57metres).

    Measured: 6 months

  18. Change in Grip strength (in kg)

    This will be assessed by comparing three and six-month assessment of grip strength compared to baseline assessment. This is measured using a hand-held dynamometer of participant's dominant hand. This is measured in kilograms.

    Measured: 6 months

  19. Changes in cognition using Mini-Addenbrooke cognitive examination

    This will be assessed by comparing the three and six-month assessments of participants' total score on the Mini-Addenbrooke Cognitive Examination compared to their baseline assessment. This is a 5-item questionnaire measured in units on a scale of 0 being the lowest score and 30 being the highest score. Scores of less than or equal 25 indicates cognitive impairment.

    Measured: 6 months

  20. Changes in Warwick-Edinburgh mental wellbeing scale

    This will be assessed by comparing three and six-month asssessment of participants' Warwick-Edinburgh Mental Wellbeing Scale as compared to their baseline assessment. This is a 14-item questionnaire and is measured units on a scale of 7 (worst possible score) to 35 (best possible score).

    Measured: 6 months

  21. Changes in Geriatric depression scale

    This will be assessed by comparing three and six-month assessment of Geriatric Depression Scale (short form) with the baseline assessment. This is a 15-item questionnaire measured in units on a scale of 0 (best possible score) to 15 (worst possible score).

    Measured: 6 months

  22. Changes in Geriatric anxiety scale

    This will be assessed by comparing three and six-month assessment of Geriatric Anxiety Scale (GAS-10) as comparing to their baseline assessment. This is a 10-item questionnaire measured on a scale of 0 (best possible score) to 10 (worst possible score).

    Measured: 6 months

  23. Changes in Health-related Quality of Life (Short-form 36)

    This will be assessed by comparing three and six-month assessment of Health-Related Quality of Life using Short-form 36 (SF-36) as compared to their baseline assessment. SF-36 is a 36-item questionnaire measured on a scale of 0 (worst possible score) to 100(best possible score).

    Measured: 6 months

  24. Changes in patient-generated index of independence

    This will be assessed by comparing three and six-month assessment of patient-generated index of independence with their baseline assessment. This is a 3-stage questionnaire where participants self-identify and rank most important activities of daily living which is measured on a scale of 0 (worst possible score) to 10 (best possible score).

    Measured: 6 months

  25. Changes in social engagement using Lubben Social Network Scale

    Social engagement of participants is assessed using Lubben Social Network Scale (LSNS- 6). This will be assessed by comparing the total score of participants' three and six-month assessment of Lubben's social network scale with their baseline assessment. This is a 6-item questionnaire measured on a scale of 0 (worst possible score) to 30 (best possible score).

    Measured: 6 months

  26. Changes in sleep using Geriatric Sleep Questionnaire

    Self-reported changes in sleep will be assessed by comparing total score on three and six-month assessment online Geriatric Sleep Questionnaire with their baseline assessment. This is a six-item questionnaire measured on a scale of 6 (best possible score) to 30 (worst possible score).

    Measured: 6 months

  27. Changes in Step Count (number of steps per day)

    Using the Withings SmartWatch, the average daily steps at 3 and 6 months will be compared with average daily steps during baseline period of the first 7 days.

    Measured: 6 months

  28. Engagement with online diaries (%)

    This is assessed by comparing the number of daily diary entriees completed online compared with the total daily diary entries completed online for participants in Group A.

    Measured: 6 months

  29. Healthcare resource utilisation

    This is assessed by number of self-reported episodes of visits to primary, secondary and tertiary healthcare facilities in all three groups during the study. This is assessed in Arm A in their daily diary entries. This is assessed in their 3 and 6-month assessments.

    Measured: 6 months

  30. Clinical Record Form (CRF) completeness (%)

    This is assessed as a percentage by comparing the number of clinical record forms completed at 3 months, 6 months, 9 months and 12 months compared with the total number of forms requested. These forms are completed by the research team for all participants.

    Measured: 12 months

  31. Change in body composition (%)

    This is assessed using Withings Smartscale which measures fat mass (in percentage). The Fat mass percentage at baseline assessment will be compared to three and six-month measurements.

    Measured: 6 months

  32. Changes in sleep - total snoring duration per night

    This is assessed using Withings Sleep mat which records the total duration of snoring. This is assessed by comparing changes as a percentage of the total snoring duration per night during the baseline period of first 7-days compared with total snoring duration per night at 3 and 6 months.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study start28 Jul 2025
  3. Primary completion26 Mar 2026 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07112352
Sponsor's protocol ID
7596188
Status last verified
Mar 2026
First submitted
9 Jul 2025
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Participants are not consented for data sharing outside team.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Smart devices with Personalised data feedback and habit coaching and Smart devices with data feedback in people with Frailty and Older Adults (65 Years and Older), run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence (%) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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