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Goodwin V1, Clarke D2, Cundill B3, Farrin A3, Forster A2, Garcia L1, Hartley S3, Hulme C1, Holland M3, Lilley-Kelly A3, Prescott M2, Wright P4, Young J2, Clegg A2
1University of Exeter, College of Medicine and Health, Exeter, United Kingdom, 2University of Leeds, Academic Unit of Elderly Care and Rehabilitation, Bradford, United Kingdom, 3University of Leeds, Clinical Trials Research Unit, Leeds, United Kingdom, 4Bradford Teaching Hospitals NHS Foundation Trust, Bradford, United Kingdom
Background: The majority of older people in hospital have frailty and are at risk of accelerated decline in skeletal muscle function. Following admission a third are likely to be discharged home after a brief period of rehabilitation but are at high risk of readmission. Those who continue to have short term rehabilitation at home (generally 6 weeks) can improve function and mobility but benefits gained may attenuate.
Purpose: The internal pilot within the randomised controlled trial (RCT) aims to assess rates of recruitment, intervention provision and acceptability and follow-up, against pre-defined criteria, to inform continuation of the RCT.
Methods: Multi-centre RCT. People, over 65 years with frailty admitted to hospital following acute illness or injury then discharged home directly from hospital or from bed or home-based intermediate care rehabilitation services were eligible. Participants were randomised in a 1.25:1 allocation ratio using a computer-generated minimisation programme. The RCT sample size is 718 across 10 sites, including 76 across 4 sites in the internal pilot. The intervention is the Home-based Older People's Exercise (HOPE) programme, a 24 week graded, progressive exercise and self-management programme delivered by physiotherapists and assistants that comprises 5 face-to-face visits and 19 telephone calls. The comparator was usual community care. Recruitment and intervention provision (defined as the proportion of intervention participants receiving their first home visit within three weeks) were assessed over months 4-6 to allow time for recruitment to stabilise; acceptability (the proportion of intervention participants retained) and follow-up (defined at the proportion completing the primary outcome measure, SF-36) will be assessed after a further three and six months respectively. Trial Registration: 13927531
Results: Recruitment opened on 1st Dec 2017. By 31st May 2018, 2848 people were screened across 4 sites and 83 were randomised (47 HOPE, 36 Usual Care). The average recruitment rate across months four to six of the pilot phase was 4-5 participants per site per month in three sites and 3 participants per month in the fourth site. Of the 47 randomised to the HOPE programme, 39 were available for their initial visit (5 withdrew and 3 discontinued treatment prior to the initial visit) and 25 (64%) of these received their initial visit within 3 weeks of randomisation. Overall, 32 (68%) of randomised participants received their initial visit at some point.
Conclusion(s): Three of the four internal pilot sites met or exceeded the green progression criteria for recruitment of 4 or more participants per month per site. The overall rate of intervention provision within 3 weeks of 64% of those available for their initial visit and 53% of all randomised intervention participants falls into the red progression criteria of less than 65% receiving their first home visit within 3 weeks.
Implications: To improve recruitment and intervention delivery we have implemented strategies:
Keywords: Older people, exercise, frailty
Funding acknowledgements: This research was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme.
Purpose: The internal pilot within the randomised controlled trial (RCT) aims to assess rates of recruitment, intervention provision and acceptability and follow-up, against pre-defined criteria, to inform continuation of the RCT.
Methods: Multi-centre RCT. People, over 65 years with frailty admitted to hospital following acute illness or injury then discharged home directly from hospital or from bed or home-based intermediate care rehabilitation services were eligible. Participants were randomised in a 1.25:1 allocation ratio using a computer-generated minimisation programme. The RCT sample size is 718 across 10 sites, including 76 across 4 sites in the internal pilot. The intervention is the Home-based Older People's Exercise (HOPE) programme, a 24 week graded, progressive exercise and self-management programme delivered by physiotherapists and assistants that comprises 5 face-to-face visits and 19 telephone calls. The comparator was usual community care. Recruitment and intervention provision (defined as the proportion of intervention participants receiving their first home visit within three weeks) were assessed over months 4-6 to allow time for recruitment to stabilise; acceptability (the proportion of intervention participants retained) and follow-up (defined at the proportion completing the primary outcome measure, SF-36) will be assessed after a further three and six months respectively. Trial Registration: 13927531
Results: Recruitment opened on 1st Dec 2017. By 31st May 2018, 2848 people were screened across 4 sites and 83 were randomised (47 HOPE, 36 Usual Care). The average recruitment rate across months four to six of the pilot phase was 4-5 participants per site per month in three sites and 3 participants per month in the fourth site. Of the 47 randomised to the HOPE programme, 39 were available for their initial visit (5 withdrew and 3 discontinued treatment prior to the initial visit) and 25 (64%) of these received their initial visit within 3 weeks of randomisation. Overall, 32 (68%) of randomised participants received their initial visit at some point.
Conclusion(s): Three of the four internal pilot sites met or exceeded the green progression criteria for recruitment of 4 or more participants per month per site. The overall rate of intervention provision within 3 weeks of 64% of those available for their initial visit and 53% of all randomised intervention participants falls into the red progression criteria of less than 65% receiving their first home visit within 3 weeks.
Implications: To improve recruitment and intervention delivery we have implemented strategies:
- Regular updates with recruiting research teams has helped to identify and overcome barriers and misconceptions linked to trial processes.
- Monthly therapist teleconferences for guidance and support to further understand initial barriers to intervention delivery and ensure fidelity to the HOPE programme.
Keywords: Older people, exercise, frailty
Funding acknowledgements: This research was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme.
Topic: Older people; Disability & rehabilitation
Ethics approval required: Yes
Institution: NHS Health Research Authority
Ethics committee: Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
Ethics number: 17/YH/0097
All authors, affiliations and abstracts have been published as submitted.
