Tailored 24-hour physical behaviours for people living with multiple conditions and frailty

Maintaining function and participation through tailored 24-hour physical behaviours for people living with multiple conditions and frailty

Registry ID
ISRCTN14362764
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
University Hospitals of Leicester NHS Trust
Enrollment
50
Start date
2025-04-30
Completion date
2028-04-30
Last update
2026-08-17

Conditions

Summary

Multiple long-term conditions and frailty

Detailed description

Current interventions as of 27/10/2025: Intervention arm: The PERSONAL-AGILITY intervention is designed to support individuals with multiple long-term conditions (MLTCs) and frailty through personalised approaches, incorporating both digital tools and shared decision-making. The intervention incorporates wearable devices (Fitbits, Apple Watches), interactive digital platforms, and web applications like MyHealthMapp and Steps4Health, to collect, monitor, and deliver healthcare information. These tools aim to improve physical activity, and sleep, and reduce sedentary behavior by providing personalised insights, feedback, and support to users and healthcare professionals (HCPs). • MyHealthMapp tracks and logs health, fitness, and physical activity data, helping individuals and HCPs monitor and compare results using personalised benchmarks. • Steps4Health offers personalised physical activity programs and support, promoting gradual increases in activity and healthy behaviors. • Personalised videos summarize individual health data to facilitate better communication and shared decision-making between participants and HCPs. The intervention emphasises shared decision-making (SDM), a collaborative approach where participants work with HCPs to make personalized healthcare decisions. It also includes face-to-face interactions, linking individuals to community activities, and considering individual preferences to ensure inclusivity beyond digital methods. Duration of treatment: 24 weeks Usual care arm: Ongoing standard care delivered by participants’ usual NHS service providers in primary and secondary care. Participants in the control group will receive generic information on the 24-hour physical behaviours. Duration of treatment 24 weeks Eligible participants (and their carer if included) in a 2:1 ratio to one of two arms: • Intervention group: the PERSONAL-AGILITY intervention OR • Control group: usual care The increased ratio of participants within the intervention group

Interventions

Inclusion criteria

Current inclusion criteria as of 27/10/2025: All patient and carer participants must be: 1. Adults ≥18 years 2. Mobile (able to walk 5 m including with the use of any walking aids) 3. Able and willing to provide informed consent 4. Able and willing to use digital and online tools with support as part of the intervention. Access to digital devices and internet is not an inclusion criterion as these resources can be provided if required to support participation. People living with MLTCs and frailty: 1. Living with ≥2 long-term non-communicable conditions 2. Living with frailty, defined as a Clinical Frailty Scale (CFS) score of 4-7 (very mildly frail to severely frail) Carers: 1. Providing regular informal care to someone living with frailty and MLTCs as defined above for ≥3 months Informal care includes (but is not limited to) emotional support, prompting with taking medications, getting prescriptions, managing, and organising appointments and care tasks, encouraging participation in social events and physical activity, helping with household tasks, or providing physical care. Healthcare professionals: 1. Clinical and non-clinical staff delivering the PERSONAL-AGILITY study 2. Aged ≥ 18 years 3. Able to provide written informed consent Previous inclusion criteria: All patient and carer participants must be: 1. Adults ≥18 years 2. Mobile (able to walk 5 m including with the use of any walking aids) 3. Able and willing to provide informed consent 4. Able and willing to use digital and online tools with support as part of the intervention. Access to digital devices and internet is not an inclusion criterion as these resources can be provided if required to support participation. People living with MLTCs and frailty: 1. Living with ≥2 long-term non-communicable conditions, one of which should be Type 2 Diabetes Mellitus (confirmed by medical history or HbA1c ≥6.0% (≥42 mmol/mol) within 3 months of trial enrolment). 2. Living with frailty, defined as a Clinical Fr

Exclusion criteria

For all participants: 1. Unable to provide informed consent 2. Unable to communicate in English 3. Known contraindications to exercise (as defined by the American College of Sports Medicine) to include: 3.1. Unstable cardiac disease (Uncontrolled arrhythmias; unstable angina or heart attack within the last 3 months; persistent uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg); stroke or transient ischaemic attack within the last 3 months) 3.2. Active infection 3.3. Significant aortic aneurysm (more than 5.5 cm) 3.4. Any other condition in which the investigator feel exercise may be contraindicated. 4. Current participation in competing clinical trial (as determined by study investigator of this trial). 5. Significant cognitive impairment (Mini mental state examination score of less than 24) or unstable psychiatric disorder that limits active participation in the intervention. 6. Serious illness or event with life-expectancy <1year, active malignancy (on chemotherapy/radiotherapy) or other significant illness which, in the opinion of a study clinician, precludes involvement. 7. Self-reportedly already regularly engaging in at least 150 minutes of moderate-to-vigorous physical activity per week. People with MLTCs and frailty: 1. Not frail as defined by: 1.1. eFI: 0 - 0.12, or 1.2. A CFS score of 1 - 3 (very fit to managing well). Carers: 1. Providing paid/professional care.

Locations

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