Healthy Ageing: a Feasibility Study to Evaluate Digitally-enabled Ways to Support Healthy Ageing
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adherence (%)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •• 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
结局指标
主要结局
Adherence (%)
时间窗: 6 months
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.
Triage effectiveness (%)
时间窗: 6 months
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.
次要结局
- 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)
- Completeness of online triage surveys (%)(6 months)
- Safety of intervention and control groups(6 months)
- Acceptability of control group(6 months)
- Acceptability of intervention using System Usability Scale - SUS(6 months)
- Acceptability of intervention using Unified Theory of Acceptance and Use of Technology(6 months)
- Changes in weight (in kg)(6 months)
- Changes in Fried Frailty Score(6 months)
- Changes in sleep (Total Sleep Duration)(6 months)
- Change in sedantary time (in minutes)(6 months)
- Changes in activity levels (number of active minutes)(6 months)
- Change in Short physical performance battery(6 months)
- Change in Gait speed (%)(6 months)
- Change in Grip strength (in kg)(6 months)
- Changes in cognition using Mini-Addenbrooke cognitive examination(6 months)
- Changes in Warwick-Edinburgh mental wellbeing scale(6 months)
- Changes in Geriatric depression scale(6 months)
- Changes in Geriatric anxiety scale(6 months)
- Changes in Health-related Quality of Life (Short-form 36)(6 months)
- Changes in patient-generated index of independence(6 months)
- Changes in social engagement using Lubben Social Network Scale(6 months)
- Changes in sleep using Geriatric Sleep Questionnaire(6 months)
- Changes in Step Count (number of steps per day)(6 months)
- Engagement with online diaries (%)(6 months)
- Healthcare resource utilisation(6 months)
- Clinical Record Form (CRF) completeness (%)(12 months)
- Change in body composition (%)(6 months)
- Changes in sleep - total snoring duration per night(6 months)