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A rehabilitation programme for people with multimorbidity versus usual care: A pilot randomized controlled trial.

ABSTRACT: Background:Multimorbidity, the coexistence of two or more chronic conditions, is common in clinical practice. Rehabilitation for people with multimorbidity may provide access to a rehabilitation programme that can address common symptoms and risk factors for multiple chronic diseases. Objective:The aims of this study were to (1) evaluate the feasibility of a rehabilitation programme compared to usual medical care (UMC) in people with multimorbidity and (2) gather preliminary data regarding clinical effects and impact on functional exercise capacity, activities of daily living, health-related quality of life and resource utilization. Design:A pilot feasibility parallel randomized controlled trial was undertaken. Adults with multimorbidity were randomized to the rehabilitation programme (intervention) or UMC (control). The duration of the rehabilitation programme was 8 weeks and comprised exercise (1 h, twice weekly) and education (1 h, once weekly). The UMC group did not participate in a structured exercise programme. Results:One hundred people were screened to recruit 16 participants, with a 71% completion rate for the intervention group. The rehabilitation group achieved a mean (standard deviation) improvement in 6-minute walk distance of 44 (41) m and the UMC group of 23 (29) m. Conclusions:This study suggests that it would be feasible to conduct a larger randomized control trial investigating a rehabilitation programme for people with multimorbidity. Low uptake of the study suggests that refinement of the inclusion criteria, recruitment sources and programme model will be needed to achieve the number of participants required.

SUBMITTER: Barker K

PROVIDER: S-EPMC6060614 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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A rehabilitation programme for people with multimorbidity versus usual care: A pilot randomized controlled trial.

Barker Kathryn K Holland Anne E AE Lee Annemarie L AL Ritchie Kathryn K Boote Claire C Lowe Stephanie S Pazsa Fiona F Thomas Lee L Turczyniak Monica M Skinner Elizabeth H EH

Journal of comorbidity 20180101 1

<h4>Background</h4>Multimorbidity, the coexistence of two or more chronic conditions, is common in clinical practice. Rehabilitation for people with multimorbidity may provide access to a rehabilitation programme that can address common symptoms and risk factors for multiple chronic diseases.<h4>Objective</h4>The aims of this study were to (1) evaluate the feasibility of a rehabilitation programme compared to usual medical care (UMC) in people with multimorbidity and (2) gather preliminary data ...[more]

PMID: 30057892

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Project description:BackgroundMultimorbidity (the co-existence of two or more chronic conditions in an individual) is a growing healthcare burden internationally; however, healthcare and disease management, including rehabilitation, is often delivered in single-disease siloes. The aims of this study were to (1) evaluate the safety and feasibility of multimorbidity rehabilitation compared to a disease-specific rehabilitation program in people with multimorbidity and (2) gather preliminary data regarding clinical outcomes and resource utilization to inform the design of future trials.MethodsA pilot feasibility randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Seventeen individuals with a chronic disease eligible for disease-specific rehabilitation (pulmonary, cardiac, heart failure rehabilitation) and at least one other chronic condition were recruited. The intervention group attended multimorbidity exercise rehabilitation and the control group attended disease-specific exercise rehabilitation. Participants attended twice-weekly exercise training and weekly education for 8 weeks. Feasibility measures included numbers screened, recruited, and completed. Other outcome measures were change in functional exercise capacity (6-minute walk test (6MWT)), health-related quality of life (HRQoL), activities of daily living (ADL), and resource utilization.ResultsSixty-one people were screened to recruit seventeen participants (nine intervention, eight control); one withdrew prior to rehabilitation. Participants were mostly male (63%) with a mean (SD) age of 69 (9) years and body mass index of 29 (6). The intervention group attended a mean (SD) of 12 (6) sessions, and the control group attended 11 (4) sessions. One participant (6%) withdrew after commencing; two (12%) were lost to follow-up. The intervention group 6MWT distance increased by mean (SD) of 22 (45) meters (95% confidence interval - 16 to 60) compared to 22 (57) meters (95% confidence interval - 69 to 114) (control).ConclusionsIt was feasible to recruit people with multimorbidity to a randomized controlled trial of rehabilitation. A large RCT with the power to make significant conclusions about the impact on the primary and secondary outcomes is now required.Trial registrationThe trial was registered with the Australian and New Zealand Clinical Trials Registry available at http://www.anzctr.org.au ACTRN12614001186640. Registered 12/11/2014.

Project description:OBJECTIVE:s: Few feasibility, safety, and efficacy data exist regarding ICU-based rehabilitative services for children. We hypothesized that early protocolized assessment and therapy would be feasible and safe versus usual care in pediatric neurocritical care patients. DESIGN:Randomized controlled trial. SETTING:Three tertiary care PICUs in the United States. PATIENTS:Fifty-eight children between the ages of 3-17 years with new traumatic or nontraumatic brain insult and expected ICU admission greater than 48 hours. INTERVENTIONS:Early protocolized (consultation of physical therapy, occupational therapy, and speech and language therapy within 72 hr ICU admission, n = 26) or usual care (consultation per treating team, n = 32). MEASUREMENTS AND MAIN RESULTS:Primary outcomes were consultation timing, treatment type, and frequency of deferrals and safety events. Secondary outcomes included patient and family functional and quality of life outcomes at 6 months. Comparing early protocolized (n = 26) and usual care groups (n = 32), physical therapy was consulted during the hospital admission in 26 of 26 versus 28 of 32 subjects (p = 0.062) on day 2.4 ± 0.8 versus 7.7 ± 4.8 (p = 0.001); occupational therapy in 26 of 26 versus 23 of 32 (p = 0.003), on day 2.3 ± 0.6 versus 6.9 ± 4.8 (p = 0.001); and speech and language therapy in 26 of 26 versus 17 of 32 (p = 0.011) on day 2.3 ± 0.7 versus 13.0 ± 10.8 (p = 0.026). More children in the early protocolized group had consults and treatments occur in the ICU versus ward for all three services (all p < 0.001). Eleven sessions were discontinued early: nine during physical therapy and two during occupational therapy, none impacting patient outcome. There were no group differences in functional or quality of life outcomes. CONCLUSIONS:A protocol for early personalized rehabilitation by physical therapy, occupational therapy, and speech and language therapy in pediatric neurocritical care patients could be safely implemented and led to more ICU-based treatment sessions, accelerating the temporal profile and changing composition of interventions versus usual care, but not altering the total dose of rehabilitation.

Project description:Fatigue is a common yet difficult to treat condition in primary care. The objective of this study is to evaluate the cost-effectiveness of a brief cognitive behavioral therapy (CBT) based fatigue self-management (FSM) intervention as compared to usual care among patients with chronic fatigue in primary care.An economic evaluation alongside of a parallel randomized controlled study design was used. Computer-generated variable-sized block randomization plan was used to assign patients into treatment groups and data collection staff were blinded to group assignments. Patients aged between 18 and 65 years with at least six months of persistent fatigue and no medical or psychiatric exclusions were enrolled from a large primary care practice in Stony Brook, New York. The FSM group (n = 37) received two sessions of a nurse-delivered, fatigue self-management protocol and a self-help book and the usual care group (n = 36) received regular medical care. The effectiveness measure was the Fatigue Severity Scale and the cost measure was total health care expenditures derived from monthly health services use diaries during follow-up. A societal perspective was adopted and bootstrapped incremental cost-effectiveness ratios (ICERs) and net monetary benefit (NMB) were calculated as measures of cost-effectiveness.The ICER for FSM was -$$2358, indicating that FSM dominates UC and it may generate societal cost savings as compared to usual care. Complete case analysis yielded smaller ICER (-$1199) with greater uncertainties. Net monetary benefit analysis showed that FSM has a probability of 0.833 (95% CI: 0.819, 0.847) to achieve positive NMB and the favorable results were not sensitive to assumptions about informal care or treatment costs.This economic evaluation found initial evidence that a two-session brief CBT-based FSM may be cost-effective as compared to usual care over 12 months. The FSM intervention is potentially a promising intervention for chronic fatigue patients in primary care. Additional research is needed to examine the reproducibility and generalizability of these findings.ClinicalTrials.gov (NCT00997451, March 28, 2009).

Project description:BackgroundExercise capacity is a strong predictor of survival in patients with coronary artery disease (CAD). Exercise capacity improves after cardiac rehabilitation exercise training, but previous studies have demonstrated a decline in peak oxygen uptake after ending a formal rehabilitation program. There is a lack of knowledge on how long-term exercise adherence can be achieved in CAD patients. We therefore assessed if a 12-month maintenance program following cardiac rehabilitation would lead to increased adherence to exercise and increased exercise capacity compared to usual care.Materials and methodsTwo-centre, open, parallel randomized controlled trial with 12 months follow-up comparing usual care to a maintenance program. The maintenance program consisted of one monthly supervised high intensity interval training session, a written exercise program and exercise diary, and a maximum exercise test every third month during follow-up. Forty-nine patients (15 women) on optimal medical treatment were included following discharge from cardiac rehabilitation. The primary endpoint was change in peak oxygen uptake at follow-up; secondary endpoints were physical activity level, quality of life and blood markers of cardiovascular risk.ResultsThere was no change in peak oxygen uptake from baseline to follow-up in either group (intervention group 27.9 (±4.7) to 28.8 (±5.6) mL·kg (-1) min (-1), control group 32.0 (±6.2) to 32.8 (±5.8) mL·kg (-1) min (-1), with no between-group difference, p = 0.22). Quality of life and blood biomarkers remained essentially unchanged, and both self-reported and measured physical activity levels were similar between groups after 12 months.ConclusionsA maintenance exercise program for 12 months did not improve adherence to exercise or peak oxygen uptake in CAD patients after discharge from cardiac rehabilitation compared to usual care. This suggests that infrequent supervised high intensity interval training sessions are inadequate to improve peak oxygen uptake in this patient group.Trial registrationClinicalTrials.gov NCT01246570.

Project description:BackgroundMultimorbidity, the co-existence of 2+ (or 3+) chronic diseases in an individual, is an increasingly common global phenomenon leading to reduced quality of life and functional status, and higher healthcare service use and mortality. There is an urgent need to develop and test new models of care that incorporate the components of multimorbidity interventions recommended by international organizations, including care coordination, interdisciplinary teams, and care plans developed with patients that are tailored to their needs and preferences.PurposeTo determine the effectiveness of a 6-month, community-based, multimorbidity intervention compared to usual home care services for community-dwelling older adults (age 65+ years) with multimorbidity (3+ chronic conditions) that were newly referred to and receiving home care services.MethodsA pragmatic, parallel, two-arm randomized controlled trial evaluated the intervention, which included in-home visits by an interdisciplinary team, personal support worker visits, and monthly case conferences. The study took place in two sites in central Ontario, Canada. Eligible and consenting participants were randomly allocated to the intervention and control group using a 1:1 ratio. The participants, statistician/analyst, and research assistants collecting assessment data were blinded. The primary outcome was the Physical Component Summary (PCS) score of the 12-Item Short-Form health survey (SF-12). Secondary outcomes included the SF-12 Mental Component Summary (MCS) score, Center for Epidemiological Studies of Depression (CESD-10), Generalized Anxiety Disorder (GAD-7), Self-Efficacy for Managing Chronic Disease, and service use and costs. Analysis of covariance (ANCOVA) tested group differences using multiple imputation to address missing data, and non-parametric methods explored service use and cost differences.Results59 older adults were randomized into the intervention (n = 30) and control (n = 29) groups. At baseline, groups were similar for the primary outcome and number of chronic conditions (mean of 8.6), but the intervention group had lower mental health status. The intervention was cost neutral and no significant group differences were observed for the primary outcome of PCS from SF-12 (mean difference: -4.94; 95% CI: -12.53 to 2.66; p = 0.20) or secondary outcomes.ConclusionWe evaluated a 6-month, self-management intervention for older adults with multimorbidity. While the intervention was cost neutral in comparison to usual care, it was not found to improve the PCS from SF-12 or secondary health outcomes. Recruitment and retention challenges were significant obstacles limiting our ability to assess intervention effectiveness. Yet, the intervention was grounded in internationally-endorsed recommendations and implemented in a practice setting (home care) viewed as a key upstream resource fostering independence in older adults. These features collectively support the identification of ways to recruit/retain older adults and test alternative implementation strategies for interventions that are based on sound principles of multimorbidity management.

Project description:BACKGROUND:Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. OBJECTIVE:The aim of this study is to compare the effects and costs of the innovative Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) intervention with usual care CR. METHODS:In this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. RESULTS:The trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. CONCLUSIONS:The innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/15022.

Project description:BackgroundTechnology development for sitting balance therapy and trunk rehabilitation is scarce. Hence, intensive one-to-one therapist-patient training is still required. We have developed a novel rehabilitation prototype, specifically aimed at providing sitting balance therapy. We investigated whether technology-supported sitting balance training was feasible and safe in chronic stroke patients and we determined whether clinical outcomes improved after a four-week programme, compared with usual care.MethodsIn this parallel-group, assessor-blinded, randomized controlled pilot trial, we divided first-event chronic stroke participants into two groups. The experimental group received usual care plus additional therapy supported by rehabilitation technology, consisting of 12 sessions of 50 min of therapy over four weeks. The control group received usual care only. We assessed all participants twice pre-intervention and once post-intervention. Feasibility and safety were descriptively analysed. Between-group analysis evaluated the pre-to-post differences in changes in motor and functional outcomes.ResultsIn total, 30 participants were recruited and 29 completed the trial (experimental group: n = 14; control group: n = 15). There were no between-group differences at baseline. Therapy was evaluated as feasible by participants and therapist. There were no serious adverse events during sitting balance therapy. Changes in clinical outcomes from pre- to post-intervention demonstrated increases in the experimental than in the control group for: sitting balance and trunk function, evaluated by the Trunk Impairment Scale (mean points score (SD) 7.07 (1.69) versus 0.33 (2.35); p < 0.000); maximum gait speed, assessed with the 10 Metre Walk Test (mean gait speed 0.16 (0.16) m/s versus 0.06 (0.06) m/s; p = 0.003); and functional balance, measured using the Berg balance scale (median points score (IQR) 4.5 (5) versus 0 (4); p = 0.014).ConclusionsTechnology-supported sitting balance training in persons with chronic stroke is feasible and safe. A four-week, 12-session programme on top of usual care suggests beneficial effects for trunk function, maximum gait speed and functional balance.Trial registrationClinicalTrials.gov identifier: NCT04467554, https://clinicaltrials.gov/ct2/show/NCT04467554 , date of Registration: 13 July 2020.

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A rehabilitation programme for people with multimorbidity versus usual care: A pilot randomized controlled trial.

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A rehabilitation programme for people with multimorbidity versus usual care: A pilot randomized controlled trial.

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