Multiple long-term conditions and frailty Other
Conditions
Interventions
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 personalis
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
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 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 27/10/2025: The primary outcome measures will assess the feasibility of a future RCT of the PERSONAL-AGILITY intervention. Qualitative data will be gathered from the process evaluation to also contextualise and enhance our understanding of these feasibility outcomes. 1. Eligibility rates are recorded as the number of eligible participants from screening logs 2. Recruitment rates recorded as the number of eligible participants who consented, separated by carer and patient groups from recruitment logs 3. Withdrawal rates recorded as rates of attrition at each stage of the study (screening, consent, randomisation by patient and carer participant group from recruitment logs 4. Outcome measure completion recorded as the number of completed measures for all secondary measures from CRF measured at baseline,12 and 24 weeks 5. Rates of uptake and engagement with each component of the PERSONAL-AGILITY intervention and of adherence recorded using a bespoke diary measured at 12 and 24 weeks. 6. Burden associated with the intervention captured using the 24-hour Physical Behaviour Burden Questionnaire measured at 12 and 24 weeks. 7. The participants' perception of the shared decision-making process using a shared decision-making questionnaire measured at 12 and 24 weeks Previous primary outcome measures: The primary outcome measures will assess the feasibility of a future RCT of the PERSONAL-AGILITY intervention. Qualitative data will be gathered from the process evaluation to also contextualise and enhance our understanding of these feasibility outcomes. 1. Eligibility rates are recorded as the number of eligible participants from screening logs 2. Recruitment rates recorded as the number of eligible participants who consented, separated by carer and patient groups from recruitment logs 3. Withdrawal rates recorded as rates of attrition at each stage of the study (screening, consent, randomisation by patient and carer participant group f | — |
Secondary
| Measure | Time frame |
|---|---|
| Semi-structured interviews will be used to explore: 1. The acceptability of key trial procedures, outcome measures and exploration of any unintended harms and consequences 2. The acceptability of the intervention including, where applicable: 2.1. The exploration of the influence of interaction between participants who took part as a ‘dyad’ 2.2. The inclusion of social prescription and engagement with community groups 2.3. Barriers and facilitators to engagement 3. Potential mechanisms of intervention impact 4. How contextual factors influenced intervention impact, including any unintended consequences 6. Their perceptions of PERSONAL-AGILITY, including its delivery and the need for any adaptations 7. How contextual influences hindered or facilitated implementation. Quantitative analysis will be undertaken using descriptive statistics. Qualitative analysis will be undertaken using a reflexive thematic approach. Added 27/10/2025: 1. Body composition is measured using bioimpedance analysis at baseline, 12 and 24 weeks 2. Blood pressure is measured using an automated sphygmomanometer at baseline, 12 and 24 weeks 3. Handgrip strength is measured using hand-held dynamometry at baseline, 12 and 24 weeks 4. Physical function is measured using the Short Physical Performance Battery at baseline, 12 and 24 weeks 5. Balance is measured using the Berg Balance Scale at baseline, 12 and 24 weeks 6. 24-hour physical behaviours (stepping, sweating, strengthening, sitting and sleep) are measured using accelerometery and inclinometry at baseline, 12 and 24 weeks 7. Quality of life is measured using the EQ-5D-5L and the Short Form-36 at baseline, 12 and 24 weeks 8. Life participation is measured using the Late Life Function and Disability Instrument at baseline, 12 and 24 weeks 9. Symptoms are measured using The Patient Outcome Scale at baseline, 12 and 24 weeks 10. Goal attainment is measured using the Goal Attainment Scale at baseline, 12 and 24 weeks 11. Care burden is measure | — |
Countries
England, United Kingdom
Contacts
Public ContactHannah Young
Outcome results
None listed