scholarly journals Self-managed occupational therapy and physiotherapy for adults receiving inpatient rehabilitation (‘My Therapy’): protocol for a stepped-wedge cluster randomised trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Natasha K. Brusco ◽  
Christina L. Ekegren ◽  
Nicholas F. Taylor ◽  
Keith D. Hill ◽  
Annemarie L. Lee ◽  
...  

Abstract Background Ensuring patients receive an effective dose of therapeutic exercises and activities is a significant challenge for inpatient rehabilitation. My Therapy is a self-management program which encourages independent practice of occupational therapy and physiotherapy exercises and activities, outside of supervised therapy sessions. Methods This implementation trial aims to determine both the clinical effectiveness of My Therapy on the outcomes of function and health-related quality of life, and cost-effectiveness per minimal clinically important difference (MCID) in functional independence achieved and per quality adjusted life year (QALY) gained, compared to usual care. Using a stepped-wedge cluster randomised design, My Therapy will be implemented across eight rehabilitation wards (inpatient and home-based) within two public and two private Australian health networks, over 54-weeks. We will include 2,160 patients aged 18 + years receiving rehabilitation for any diagnosis. Each ward will transition from the usual care condition (control group receiving usual care) to the experimental condition (intervention group receiving My Therapy in addition to usual care) sequentially at six-week intervals. The primary clinical outcome is achievement of a MCID in the Functional Independence Measure (FIM™) at discharge. Secondary outcomes include improvement in quality of life (EQ-5D-5L) at discharge, length of stay, 30-day re-admissions, discharge accommodation, follow-up rehabilitation services and adverse events (falls). The economic outcomes are the cost-effectiveness per MCID in functional independence (FIM™) achieved and per QALY gained, for My Therapy compared to usual care, from a health-care sector perspective. Cost of implementation will also be reported. Clinical outcomes will be analysed via mixed-effects linear or logistic regression models, and economic outcomes will be analysed via incremental cost-effectiveness ratios. Discussion The My Therapy implementation trial will determine the effect of adding self-management within inpatient rehabilitation care. The results may influence health service models of rehabilitation including recommendations for systemic change to the inpatient rehabilitation model of care to include self-management. Findings have the potential to improve patient function and quality of life, and the ability to participate in self-management. Potential health service benefits include reduced hospital length of stay, improved access to rehabilitation and reduced health service costs. Trial registration This study was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12621000313831; registered 22/03/2021, http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380828&isReview=true).

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Siriwan Choojaturo ◽  
Siriorn Sindhu ◽  
Ketsarin Utriyaprasit ◽  
Chukiat Viwatwongkasem

Abstract Background The main purpose of health service systems is to improve patients’ quality of life (QoL) and to ensure equitable access to health services. However, in reality, nearly half of knee osteoarthritis (OA) patients present to the health system do not have access to health services, and their QoL remains poor. These circumstances raise important questions about what (if any) factors can improve health care accessibility and QoL for knee OA patients. Methods A multicenter, cross-sectional survey was performed with 618 knee OA patients who received care at 16 hospitals in Thailand. Structural equation modeling (SEM) was conducted to investigate the association of health service factors and patient factors with access to health services and QoL. Results The QoL of knee OA patients was very poor (mean score = 33.8). Only 2.1% of the knee OA patients found it easy to obtain medical care when needed. Approximately 39.4% of them were able to access appropriate interventions before being referred for knee replacement. More than 85% of orthopedic health services had implemented chronic disease management (CDM) policy into practice. However, the implementation was basic, with an average score of 5.9. SEM showed that QoL was determined by both health system factors (β = .10, p = .01) and patient factors (β = .29, p = .00 for self-management and β = −.49, p = .00 for disease factors). Access to health services was determined by self-management (β = .10, p = .01), but it was not significantly associated with QoL (β = .00, p = 1.0). Conclusions This study provides compelling information about self-management, access to health services and QoL from the individual and health service system perspectives. Furthermore, it identifies a need to develop health services that are better attuned to the patient’s background, such as socioeconomic status, disease severity, and self-management skills.


2018 ◽  
Vol 51 (1) ◽  
pp. 1701375 ◽  
Author(s):  
Claudia Steurer-Stey ◽  
Kaba Dalla Lana ◽  
Julia Braun ◽  
Gerben ter Riet ◽  
Milo A. Puhan

The pivotal objective of chronic obstructive pulmonary disease (COPD) self-management programmes is behaviour change to avoid moderate and severe exacerbations and improve health related quality of life.In a prospectively planned, controlled study, COPD patients who participated in the “Living well with COPD” (LWWCOPD) self-management intervention were compared with usual care patients from the primary care COPD Cohort ICE COLD ERIC, who did not receive self-management intervention (NCT00706602) The primary outcome was behaviour change and disease-specific health related quality of life after 1 year. Secondary end-points included exacerbation rates. We calculated mixed linear, zero-inflated negative binomial and logistic regression models and used propensity scores to counteract confounding.467 patients, 71 from the LWWCOPD and 396 from the usual care cohort, were included. The differences between intervention and control were 0.54 (95% CI 0.13−0.94) on the Chronic Respiratory Questionnaire domain “mastery”, 0.55 (95% CI 0.11−0.99) on “fatigue”, 0.54 (0.14−0.93) on “emotional function” and 0.64 (95% CI 0.14−1.14) on “dyspnoea”. The intervention considerably reduced the risk of moderate and severe exacerbations (incidence rate ratio 0.36, 95% CI 0.25−0.52).Self-management coaching in primary care improves health-related quality of life and lowers exacerbation rates and health care use.


2020 ◽  
pp. 096452842092028
Author(s):  
Alex Molassiotis ◽  
Bryony Dawkins ◽  
Roberta Longo ◽  
Lorna KP Suen ◽  
Hui Lin Cheng ◽  
...  

Objective To assess the cost-effectiveness of acupuncture in the management of chemotherapy-induced peripheral neuropathy (CIPN) in Hong Kong. Methods A within trial cost-utility analysis with the primary endpoint for the economic evaluation being the Quality Adjusted Life Year (QALY) and associated Incremental Cost Effectiveness Ratio (ICER) over 14 weeks of treatment. A secondary cost-effectiveness analysis was undertaken with the endpoint being change in pain as measured on the Brief Pain Inventory (BPI). Results Eighty-seven patients were randomised to acupuncture or usual care. Acupuncture resulted in significant improvements in pain intensity (8- and 14-week mean changes compared to usual care of −1.8 and −1.8, respectively), pain interference (8- and 14-week mean changes compared to usual care of −1.5 and −0.9, respectively) and indicators of quality of life and neurotoxicity-related symptoms. However, in the economic evaluation there was little difference in QALYs between the two arms (mean change 0.209 and 0.200 in the acupuncture and usual care arms, respectively). Also, costs yielded deterministic ICERs of HK$616,965.62, HK$824,083.44 and HK$540,727.56 per QALY gained from the health care provider perspective, the societal perspective and the patient perspective, respectively. These costs are significantly higher than the cost-effectiveness threshold of HK$180,450 that was used for the base case analysis. Conclusion While acupuncture can improve symptoms and quality of life indicators related to CIPN, it is unlikely to be a cost-effective treatment for CIPN-related pain in health care systems with limited resources. Trial registration number NCT02553863 (ClinicalTrials.gov) post-results.


2021 ◽  
pp. 109980042098454
Author(s):  
Kendra J. Kamp ◽  
Anna M. Plantinga ◽  
Kevin C. Cain ◽  
Robert L. Burr ◽  
Pamela Barney ◽  
...  

Background and Purpose: Changes in diet and lifestyle factors are frequently recommended for persons with irritable bowel syndrome (IBS). It is unknown whether these recommendations alter the gut microbiome and/or whether baseline microbiome predicts improvement in symptoms and quality of life following treatment. Therefore, the purpose of this study was to explore if baseline gut microbiome composition predicted response to a Comprehensive Self-Management (CSM) intervention and if the intervention resulted in a different gut microbiome composition compared to usual care. Methods: Individuals aged 18–70 years with IBS symptoms ≥6 months were recruited using convenience sampling. Individuals were excluded if medication use or comorbidities would influence symptoms or microbiome. Participants completed a baseline assessment and were randomized into the eight-session CSM intervention which included dietary education and cognitive behavioral therapy versus usual care. Questionnaires included demographics, quality of life, and symptom diaries. Fecal samples were collected at baseline and 3-month post-randomization for 16S rRNA-based microbiome analysis. Results: Within the CSM intervention group (n = 30), Shannon diversity, richness, and beta diversity measures at baseline did not predict benefit from the CSM intervention at 3 months, as measured by change in abdominal pain and quality of life. Based on both alpha and beta diversity, the change from baseline to follow-up microbiome bacterial taxa did not differ between CSM (n = 25) and usual care (n = 25). Conclusions and Inferences: Baseline microbiome does not predict symptom improvement with CSM intervention. We do not find evidence that the CSM intervention influences gut microbiome diversity or composition over the course of 3 months.


2020 ◽  
Vol 9 (7) ◽  
pp. 2160
Author(s):  
Nancy Helou ◽  
Dominique Talhouedec ◽  
Maya Zumstein-Shaha ◽  
Anne Zanchi

Individuals with diabetic kidney disease are at high risk of complications and challenged to self-manage. Previous research suggested that multidisciplinary approaches would improve health outcomes. This study investigated the effect of a multidisciplinary self-management approach of diabetic kidney disease on quality of life, and self-management, glycemic control, and renal function. A uniform balanced crossover design was used because it attains a high level of statistical power with a lower sample size. A total of 32 participants (aged 67.8 ± 10.8) were randomized into four study arms. In differing sequences, each participant was treated twice with three months of usual care alternated with three months of multidisciplinary management. The intervention improved the present dimension of quality of life demonstrating higher mean rank as compared to usual care (52.49 vs. 41.01; p = 0.026, 95% CI) and three self-care activities, general diet habits, diabetes diet habits, and blood sugar testing (respectively: 55.43 vs. 38.31; p = 0.002, 56.84 vs. 37.02; p = 0.000, 53.84 vs. 39.77; p = 0.008; 95% CI). Antihypertensive medication engagement was high across the study period (Mean = 95.38%, Min = 69%, Max = 100%). Glycemic control and renal function indicators were similar for the intervention and the usual care. Studies are needed to determine how the new recommended therapies for diabetic kidney disease such as SGLT2 inhibitors and GLP-1 receptor agonists impact on self-management and quality of life.


2021 ◽  
Author(s):  
Maryam Hajmohamadi ◽  
Sakineh Sabzvari ◽  
Yones Jahani ◽  
Zahra Imani- Goghary

Abstract Background: Some symptoms such as fatigue and dyspnea decrease the quality of life in patients with heart failure. The effectiveness of self-management programs on management chronic conditions was discussed. So, this study aimed to investigate the effectiveness of self-management program based on 5A model on fatigue and dyspnea in patients with heart failure.Materials and Methods: In this clinical trial study, 60 patients with heart failure were included. The intervention group underwent self-management program based on 5A model and the control group received routine care. All the enrolled patients were evaluated once at baseline and once after 3 months using fatigue severity and Borg dyspnea scales. The obtained data were analyzed using SPSS software version 16 by descriptive statistics and independent t-test, covariance test, and paired sample t- test. The significance level was set at 0.05.Results: There was no significant difference in the mean scores of fatigue and dyspnea at the beginning of the study between control and intervention groups (p>0.05), but 3 months after intervention a significant difference was found in mean scores of fatigue and dyspnea between two groups, (p<0.05). The difference between pre- and post-intervention scores in terms of the dyspnea and fatigue variables was significant based on the result of paired sample t- test (p<0.05).Conclusion: according to the results of this study, self-management program based on 5A Model can be used to reduce the severity of fatigue and dyspnea as well as improve the quality of life in patients with heart failure. Trial registration number: IRCT20141109019862N8 Trial registration date: 11/Aug/2019First participant enrollment: 30 /Sep/ 2019:


10.2196/13145 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e13145
Author(s):  
Thijs Beerthuizen ◽  
Lucia H Rijssenbeek-Nouwens ◽  
Sophia M van Koppen ◽  
Rishi J Khusial ◽  
Jiska B Snoeck-Stroband ◽  
...  

Background In patients with severe asthma, high-altitude climate treatment has been shown to improve asthma control. However, asthma symptoms and limitations may increase after finishing inpatient rehabilitation programs and returning to sea level. Objective We assessed the effectiveness of a patient-tailored, internet-based, self-management strategy in addition to usual care after finishing high-altitude climate treatment. Methods We performed a randomized controlled trial with a 1-year follow-up in patients from a high-altitude asthma center in Davos, Switzerland. At the end of a 12-week multidisciplinary rehabilitation program, 62 adults with asthma were randomized to receive either internet-based self-management support in addition to usual care (n=33) or usual care only after discharge (n=29). The endpoints were changes in asthma-related quality of life according to the Asthma Quality of Life Questionnaire (AQLQ) (a higher score is better) and asthma control according to the Asthma Control Questionnaire (ACQ) (a lower score is better), with a minimally important difference of 0.5 points for both. Results Asthma-related quality of life and asthma control declined over time in the usual care strategy group, whereas there was a slower decline in the internet-based strategy group. For both endpoints, mixed-model analysis showed a significant positive effect in favor of internet-based self-management during follow-up (mean AQLQ score difference 0.39, 95% CI 0.092-0.69; P=.01 and ACQ score difference −0.50, 95% CI −0.86 to −0.15; P=.006), which was prominent among patients with uncontrolled asthma at discharge (AQLQ score difference 0.59, 95% CI 0.19-0.99; P=.003 and ACQ score difference −0.73, 95% CI −1.18 to −0.28; P=.002). Conclusions Internet-based self-management support was associated with a smaller decline in quality of life and asthma control as compared with usual care, especially in patients with lower asthma control, after completion of high-altitude climate treatment. Internet-based self-management support in adults with severe asthma seems feasible and effective to maintain quality of life and asthma control. Trial Registration The trial is registered in the Netherlands Trial Register (NTR1995).


2018 ◽  
Vol 22 (21) ◽  
pp. 1-142 ◽  
Author(s):  
Leone Ridsdale ◽  
Alison McKinlay ◽  
Gabriella Wojewodka ◽  
Emily J Robinson ◽  
Iris Mosweu ◽  
...  

BackgroundEpilepsy is a common neurological condition resulting in recurrent seizures. Research evidence in long-term conditions suggests that patients benefit from self-management education and that this may improve quality of life (QoL). Epilepsy self-management education has yet to be tested in a UK setting.ObjectivesTo determine the effectiveness and cost-effectiveness of Self-Management education for people with poorly controlled epILEpsy [SMILE (UK)].DesignA parallel pragmatic randomised controlled trial.SettingParticipants were recruited from eight hospitals in London and south-east England.ParticipantsAdults aged ≥ 16 years with epilepsy and two or more epileptic seizures in the past year, who were currently being prescribed antiepileptic drugs.InterventionA 2-day group self-management course alongside treatment as usual (TAU). The control group received TAU.Main outcome measuresThe primary outcome is QoL in people with epilepsy at 12-month follow-up using the Quality Of Life In Epilepsy 31-P (QOLIE-31-P) scale. Other outcomes were seizure control, impact of epilepsy, medication adverse effects, psychological distress, perceived stigma, self-mastery and medication adherence. Cost-effectiveness analyses and a process evaluation were undertaken.RandomisationA 1 : 1 ratio between trial arms using fixed block sizes of two.BlindingParticipants were not blinded to their group allocation because of the nature of the study. Researchers involved in data collection and analysis remained blinded throughout.ResultsThe trial completed successfully. A total of 404 participants were enrolled in the study [SMILE (UK),n = 205; TAU,n = 199] with 331 completing the final follow-up at 12 months [SMILE (UK),n = 163; TAU,n = 168]. In the intervention group, 61.5% completed all sessions of the course. No adverse events were found to be related to the intervention. At baseline, participants had a mean age of 41.7 years [standard deviation (SD) 14.1 years], and had epilepsy for a median of 18 years. The mean QOLIE-31-P score for the whole group at baseline was 66.0 out of 100.0 (SD 14.2). Clinically relevant levels of anxiety symptoms were reported in 53.6% of the group and depression symptoms in 28.0%. The results following an intention-to-treat analysis showed no change in any measures at the 12-month follow-up [QOLIE-31-P: SMILE (UK) mean: 67.4, SD 13.5; TAU mean: 69.5, SD 14.8]. The cost-effectiveness study showed that SMILE (UK) was possibly cost-effective but was also associated with lower QoL. The process evaluation with 20 participants revealed that a group course increased confidence by sharing with others and improved self-management behaviours.ConclusionsFor people with epilepsy and persistent seizures, a 2-day self-management education course is cost-saving, but does not improve QoL after 12-months or reduce anxiety or depression symptoms. A psychological intervention may help with anxiety and depression. Interviewed participants reported attending a group course increased their confidence and helped them improve their self-management.Future workMore research is needed on self-management courses, with psychological components and integration with routine monitoring.Trial registrationCurrent Controlled Trials ISRCTN57937389.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 21. See the NIHR Journals Library website for further project information.


Stroke ◽  
2020 ◽  
Vol 51 (9) ◽  
pp. 2639-2648 ◽  
Author(s):  
Tara D. Klassen ◽  
Sean P. Dukelow ◽  
Mark T. Bayley ◽  
Oscar Benavente ◽  
Michael D. Hill ◽  
...  

Background and Purpose: We investigated the effect of higher therapeutic exercise doses on walking during inpatient rehabilitation, typically commencing 1 to 4 weeks poststroke. Methods: This phase II, blinded-assessor, randomized controlled trial recruited from 6 Canadian inpatient rehabilitation units, between 2014 and 2018. Subjects (n=75; 25/group) were randomized into: control (usual care) physical therapy: typically, 1 hour, 5 days/week; Determining Optimal Post-Stroke Exercise (DOSE1): 1 hour, 5 days/week, more than double the intensity of Control (based on aerobic minutes and walking steps); and DOSE2: 2 hours, 5 days/week, more than quadruple the intensity of Control, each for 4 weeks duration. The primary outcome, walking endurance at completion of the 4-week intervention (post-evaluation), was compared across these groups using linear regression. Secondary outcomes at post-evaluation, and longitudinal outcomes at 6 and 12-month evaluations, were also analyzed. Results: Both DOSE1 (mean change 61 m [95% CI, 9–113], P =0.02) and DOSE2 (mean change 58 m, 6–110, P =0.03) demonstrated greater walking endurance compared with Control at the post-evaluation. Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control. Longitudinal analyses revealed that improvements in walking endurance from the DOSE intervention were retained during the 1-year follow-up period over usual care. Conclusions: This study provides the first preliminary evidence that patients with stroke can improve their walking recovery and quality of life with higher doses of aerobic and stepping activity within a critical time period for neurological recovery. Furthermore, walking endurance benefits achieved from a 4-week intervention are retained over the first-year poststroke. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01915368.


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