Overview
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
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.
Eligibility
Inclusion Criteria:
- • 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
Exclusion Criteria:
- • 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