Dataset Information

Stepped care versus center-based cardiopulmonary rehabilitation for older frail adults living in rural MA: Design of a feasibility randomized controlled trial.

ABSTRACT:

Background

Cardiac and pulmonary rehabilitation programs are grossly underutilized, and participation is particularly low in rural regions.

Methods

We are conducting a 2-arm, randomized controlled feasibility trial. Eligible participants include older frail adults with cardiac or pulmonary disease living in a predominantly rural county in western Massachusetts. Participants are randomized 1:1 to treatment as usual or stepped care. Patients randomized to treatment as usual participate in twice weekly center-based rehabilitation sessions over eight weeks and are encouraged to exercise at home in between sessions. Patients randomized to the stepped-care arm are offered/enrolled in the center-based rehabilitation program followed by possible step up to three interventions based on prespecified non-response criteria: 1) Transportation-assisted center-based rehabilitation, 2) Home-based telerehabilitation, and 3) Community health worker-supported home-based telerehabilitation. The primary feasibility outcomes are average number of eligible patients randomized per month, baseline measure completion, proportion attending at least 70% of the prescribed sessions, average number of sessions attended in the stepped-care arm, and proportion in the stepped-care arm completing patient reported outcome measures. Each of these process indicators is evaluated by preset "Stop" and "Go" thresholds.

Conclusion

The proposed stepped-care model is an efficient, patient-centered, approach to expanding access to cardiac and pulmonary rehabilitation. Meeting the "Go" thresholds for the prespecified process indicators will justify conducting a definitive full-scale randomized controlled trial to compare the effectiveness and value (cost-effectiveness) of stepped-care versus center-based rehabilitation in older frail adults living rural counties.

SUBMITTER: Fraenkel L

PROVIDER: S-EPMC10164764 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

Stepped care versus center-based cardiopulmonary rehabilitation for older frail adults living in rural MA: Design of a feasibility randomized controlled trial.

Fraenkel Liana L Pack Quinn Q Drager Leslie L Patel Jagruti J Pontier Paulette P Lindenauer Peter K PK

Contemporary clinical trials communications 20230423

<h4>Background</h4>Cardiac and pulmonary rehabilitation programs are grossly underutilized, and participation is particularly low in rural regions.<h4>Methods</h4>We are conducting a 2-arm, randomized controlled feasibility trial. Eligible participants include older frail adults with cardiac or pulmonary disease living in a predominantly rural county in western Massachusetts. Participants are randomized 1:1 to treatment as usual or stepped care. Patients randomized to treatment as usual particip ...[more]

PMID: 37168819

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Project description:BackgroundRehabilitation potential involves predicting who will benefit from rehabilitation. Decisions about rehabilitation potential must take into account personal, clinical and contextual factors, a process which is complicated in the presence of acute ill-health and frailty. This study aimed to evaluate the feasibility and acceptability of the Rehabilitation Potential Assessment Tool (RePAT) - a 15 item holistic, person-centred assessment tool and training package - in the acute hospital setting.MethodsA non-randomised feasibility study with nested semi-structured interviews explored whether RePAT was feasible and acceptable. Feasibility was tested by recruiting physiotherapy and occupational therapy participants delivering the RePAT intervention to patients alongside usual clinical care. Acceptability was tested by conducting semi-structured interviews with staff, patient and carer participants. Staff and patient characteristics were analysed using descriptive statistics. Interview data were analysed thematically. Fidelity of completed RePAT items was assessed against a priori criteria on how closely they matched tool guidance by two researchers. Mean values of the two scores were calculated. RePAT content was analysed and supported with verbatim quotes.ResultsSix staff participants were recruited and trained. They assessed 26 patient participants using RePAT. Mean (SD) patient age was 86.16 (±6.39) years. 32% were vulnerable or mildly frail, 42% moderately frail and 26% severely or very severely frail using the Clinical Frailty Scale. Mean (SD) time to complete RePAT was 32.7 (±9.6) minutes. RePAT fidelity was good where 13 out of 15 items achieved a priori fidelity. RePAT was acceptable and tolerated by staff and patients. Staff participants reported RePAT enabled them to consider rehabilitation decisions in a more structured and consistent way. Patients and carer participants, although unable to comment directly on RePAT, reported being satisfied with their rehabilitation assessments which were found to embrace a person-centred approach.ConclusionsRePAT was found to be acceptable and feasible by staff, carers and patients. It allowed clinicians to make explicit their reasoning behind rehabilitation assessments and encouraged them to become more cognisant of factors which affected their clinical decision-making.Trial registrationID ISRCTN31938453 . Registered 05/10/2021.

Project description:BackgroundSarcopenia is a progressive and generalised loss of muscle mass and function with advancing age and is a major contributor to frailty. These conditions lead to functional disability, loss of independence, and lower quality of life. Sedentary behaviour is adversely associated with sarcopenia and frailty. Reducing and breaking up sitting should thus be explored as an intervention target for their management. The primary aim of this study, therefore, is to examine the feasibility, safety, and acceptability of conducting a randomised controlled trial (RCT) that evaluates a remotely delivered intervention to improve sarcopenia and independent living via reducing and breaking up sitting in frail older adults.MethodsThis mixed-methods randomised controlled feasibility trial will recruit 60 community-dwelling older adults aged ≥ 65 years with very mild or mild frailty. After baseline measures, participants will be randomised to receive the Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention or serve as controls (usual care) for 6 months. Frail-LESS is a remotely delivered intervention comprising of tailored feedback on sitting, information on the health risks of excess sitting, supported goal setting and action planning, a wearable device that tracks inactive time and provides alerts to move, health coaching, and peer support. Feasibility will be assessed in terms of recruitment, retention and data completion rates. A process evaluation will assess intervention acceptability, safety, and fidelity of the trial. The following measures will be taken at baseline, 3 months, and 6 months: sitting, standing, and stepping using a thigh-worn activPAL4 device, sarcopenia (via hand grip strength, muscle mass, and physical function), mood, wellbeing, and quality of life.DiscussionThis study will determine the feasibility, safety, and acceptability of evaluating a remote intervention to reduce and break up sitting to support improvements in sarcopenia and independent living in frail older adults. A future definitive RCT to determine intervention effectiveness will be informed by the study findings.Trial registrationISRCTN, ISRCTN17158017; Registered 6 August 2021, https://www.isrctn.com/ISRCTN17158017.

Project description:BackgroundSarcopenia leads to functional disability, dependence in activities of daily living (ADL), and is a key contributor to frailty. Reducing and breaking up sedentary time is associated with improved sarcopenia and frailty-related outcomes. The aim of this study was to determine the feasibility of delivering and evaluating a remote sedentary behaviour intervention to improve sarcopenia and independent living in older adults with frailty.MethodsA two-arm randomised controlled feasibility trial was conducted with a target of 60 older adults (mean age 74 ± 6 years) with very mild or mild frailty. Participants were randomised to the Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention or usual care control group for six months. The intervention included tailored feedback on sitting, standing and stepping; an education workbook that included goal setting and action planning; one-to-one health coaching; peer support; and a wearable device to self-monitor sedentary behaviour. Participant recruitment (percentage of eligible individuals recruited), retention and data completion rates were used to assess trial feasibility. Acceptability of the trial was explored through interviews and safety was evaluated via unplanned healthcare utilisation and number of falls. Sitting, standing, stepping and sarcopenia were measured to evaluate potential intervention effects.ResultsSixty participants were recruited. Recruitment and retention rates were 72% and 83%, respectively. Completion rates for outcome measures ranged from 70 to 100%. The trial was safe (< 1 fall per participant on average at each timepoint) and trial procedures were acceptable. Descriptive analysis (mean ± SD) showed that daily sitting was 25.1 ± 82.1 min/day lower in the intervention group, and 6.4 ± 60.5 min/day higher in the control group, at 6 months compared with baseline. Hand grip strength and sit-to-stand score were improved by 1.3 ± 2.4 kg and 0.7 ± 1.0, respectively, in the intervention group.ConclusionsThis study demonstrates the feasibility and safety of delivering and evaluating a remote intervention to reduce and break up sitting in older adults with frailty. The intervention showed evidence towards reducing daily sitting and improving sarcopenia, supporting its evaluation in a definitive randomised controlled trial.Trial registrationISRCTN registry (registration number: ISRCTN17158017). Registered 6th August 2021.

Project description:Whole-body electromyostimulation (WB-EMS) induces high-intense stimuli to skeletal muscles with low strain on joints and the autonomic nervous system and may thus be suitable for frail, older people. However, if trained at very high intensities, WB-EMS may damage muscles and kidneys (rhabdomyolysis). This study aimed at investigating the feasibility, safety and preliminary efficacy of WB-EMS in frail, older people. Seven frail (81.3 ± 3.5 years), 11 robust (79.5 ± 3.6 years), 10 young (29.1 ± 6.4 years) participants completed an eight-week WB-EMS training (week 1-4: 1x/week; week 5-8: 1.5x/week) consisting of functional exercises addressing lower extremity strength and balance. Feasibility was assessed using recruitment, adherence, retention, and dropout rates. The satisfaction with WB-EMS was measured using the Physical Activity Enjoyment Scale for older adults (PACES-8). In week 1, 3, and 8 creatine kinase (CK) was assessed immediately before, 48 and 72 h after WB-EMS. Symptoms of rhabdomyolysis (muscle pain, muscle weakness, myoglobinuria) and adverse events were recorded. Functional capacity was assessed at baseline and after 8 weeks using the Short Physical Performance Battery (SPPB), Timed Up-and-Go Test (TUG), Choice Stepping Reaction Time Test (CSRT), 30-second Chair-Stand Test (30-STS), maximum isometric leg strength and handgrip strength. The recruitment rate of frail individuals was 46.2%, adherence 88.3% and the dropout rate 16.7%. All groups indicated a high satisfaction with WB-EMS. CK activity was more pronounced in young individuals with significant changes over time. Within older people CK increased borderline-significantly in the frail group from baseline to week 1 but not afterwards. In robust individuals CK increased significantly from baseline to week 1 and 3. No participant reached CK elevations close to the threshold of ≥5,000 U/l and no symptoms of rhabdomyolysis were observed. With the exception of the TUG (p = 0.173), frail individuals improved in all tests of functional capacity. Compared to the young and robust groups, frail individuals showed the greater improvements in the SPPB, handgrip strength, maximum isokinetic hip-/knee extension and flexion strength. WB-EMS is feasible for frail older people. There were no clinical signs of exertional rhabdomyolysis. WB-EMS proved to be sufficiently intense to induce meaningful changes in functional capacity with frail individuals showing greater improvements for several measures.

Project description:BackgroundDuring care transitions, the older (75+) patient's agenda can easily be missed. To counteract this, involving patients in shared clinical decision making has proven to be of great value. Likewise, involving patients and other stakeholders as researchers is gaining ground. Patient and public involvement (PPI) in research entails many benefits, for example, by bringing further insight from those with lived experiences of being ill. There are various challenges associated with involving some older patients, for example frailty, cognitive impairment and other chronic illnesses. To the best of our knowledge, there are only a few examples of initiatives involving older patients beyond research participation. The feasibility of involving frail older patients during an ongoing care transition from hospital to primary health care remains unknown. To investigate the feasibility of including older frail patients, their relatives and health care professionals (HCPs) as co-researchers, we established a study with increasingly demanding levels of patient involvement to identify relevant outcome measures for future transitional care research.MethodsThe study was a pragmatic, qualitative feasibility study. The involved individuals were frail older patients, their relatives and HCPs. Patients and their relatives were interviewed, while the interviewer made reflective notes. A thematic analysis was made. Relatives and HCPs discussed the themes to identify relevant outcome measures and potentially co-create new patient-reported outcome measures (PROMs) for use in future transitional care studies. The feasibility was evaluated according to six involvement steps. The level of involvement was evaluated using the five-levelled Health Canada Public Involvement Continuum (HCPIC).ResultsIn total, eight patients, five relatives and three HCPs were involved in the study. Patients were involved in discussing care transitions (HCPIC level 3), while some relatives were engaged (HCPIC level 4) in forming PROMs. The partnership level of involvement (HCPIC level 5) was not reached. The thematic analysis and the subsequent theme discussion successfully formed PROMs. The key PROMs were related to care, transparency and the relatives' roles in the transitional care process.ConclusionsWhen applying a pragmatic involvement approach, frail older patients can be successfully involved in identifying relevant transitional care outcome measures; however, involving these patients as fellow researchers seems infeasible. To maintain involvement, supportive relatives are essential. Useful experiences for future research involvement of this vulnerable group were reported, arguing that patient participation has the potential to become inherent in future geriatric research.

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Project description:IntroductionFrailty is conventionally diagnosed using clinical tests and self-reported assessments. However, digital health technologies (DHTs), such as wearable accelerometers, can capture physical activity and gait during daily life, enabling more objective assessments. In this study, we assess the feasibility of deploying DHTs in community-dwelling older individuals, and investigate the relationship between digital measurements of physical activity and gait in naturalistic environments and participants' frailty status, as measured by conventional assessments.MethodsFried Frailty Score (FFS) was used to classify fifty healthy individuals as non-frail (FFS = 0, n/female = 21/11, mean ± SD age: 71.10 ± 3.59 years), pre-frail (FFS = 1-2, n/female = 23/9, age: 73.74 ± 5.52 years), or frail (FFS = 3+, n/female = 6/6, age: 70.70 ± 6.53 years). Participants wore wrist-worn and lumbar-worn GENEActiv accelerometers (Activinsights Ltd., Kimbolton, UK) during three in-laboratory visits, and at-home for 2 weeks, to measure physical activity and gait. After this period, they completed a comfort and usability questionnaire. Compliant days at-home were defined as follows: those with ≥18 h of wear time, for the wrist-worn accelerometer, and those with ≥1 detected walking bout, for the lumbar-worn accelerometer. For each at-home measurement, a group analysis was performed using a linear regression model followed by ANOVA, to investigate the effect of frailty on physical activity and gait. Correlation between at-home digital measurements and conventional in-laboratory assessments was also investigated.ResultsParticipants were highly compliant in wearing the accelerometers, as 94% indicated willingness to wear the wrist device, and 66% the lumbar device, for at least 1 week. Time spent in sedentary activity and time spent in moderate activity as measured from the wrist device, as well as average gait speed and its 95th percentile from the lumbar device were significantly different between frailty groups. Moderate correlations between digital measurements and self-reported physical activity were found.ConclusionsThis work highlights the feasibility of deploying DHTs in studies involving older individuals. The potential of digital measurements in distinguishing frailty phenotypes, while unobtrusively collecting unbiased data, thus minimizing participants' travels to sites, will be further assessed in a follow-up study.

Dataset Information

Stepped care versus center-based cardiopulmonary rehabilitation for older frail adults living in rural MA: Design of a feasibility randomized controlled trial.

Background

Methods

Conclusion

Publications

Stepped care versus center-based cardiopulmonary rehabilitation for older frail adults living in rural MA: Design of a feasibility randomized controlled trial.

Similar Datasets

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