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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
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 (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.
Standard care where they will be signposted to National Health Service (NHS) guidance on Healthy Ageing for older adults.
Helix Centre, Institute of Global Health Innovation, Department of Surgery and Cancer, Imperial College London
London, United Kingdom
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.
Time frame: 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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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
Time frame: 6 months
Changes in weight (in kg)
Using Withings Smartscale, weight (in kilograms) at three and six months will be compared to baseline assessment.
Time frame: 6 months
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).
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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).
Time frame: 6 months
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).
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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).
Time frame: 6 months
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).
Time frame: 6 months
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).
Time frame: 6 months
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).
Time frame: 6 months
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).
Time frame: 6 months
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).
Time frame: 6 months
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).
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 12 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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