| 1. |
- Andersson-Marforio, Sonja, et al.
(author)
-
Physiotherapy interventions encouraging frequent changes of the body position and physical activity for infants hospitalised with bronchiolitis : an internal feasibility study of a randomised control trial
- 2022
-
In: Pilot and Feasibility Studies. - : Springer Science and Business Media LLC. - 2055-5784. ; 8, s. 1-10
-
Journal article (peer-reviewed)abstract
- BACKGROUND: The effect of a treatment that includes frequent changes of the body position for infants with bronchiolitis has not been evaluated, although it is often used in Swedish hospitals. Because of this, a randomised control trial (RCT) has begun with the aim to evaluate this treatment, comparing the effect of an individualised physiotherapy intervention, a non-individualised intervention, and standard care in a control group. The objective of this internal pilot study was to address uncertainties concerning the ongoing RCT and to determine whether the trial is feasible or not, possibly with adjustments to the protocol.METHODS: Descriptive analyses of the recruitment, retention, data supply for the primary end point, and the usability of the primary outcome measure in the full RCT were performed. A safety analysis was conducted by an independent analysis group.RESULTS: Ninety-one infants were included, 33 (36.3%), 28 (30.8%), and 30 (33.0%) in the respective allocation groups. Fifty-nine (64.8%) were boys. The median age was 2.5 (min-max 0.2-23.7) months. They remained in the study for a median of 46 hours (min-max 2-159). The recruitment rate was 19%. The data supply for the primary end point and for the primary outcome measure was lower than anticipated in the original sample size calculation. Difficulties concerning utilising the primary outcome measure were identified. The safety analysis detected no risks of harm related to participation in the study.CONCLUSIONS: It is feasible to continue the RCT with modifications of the analysis plan. Participation in the study was not associated with any safety risks.TRIAL REGISTRATION: ClinicalTrials.gov NCT03575091 . Registered 2 July 2018. Retrospectively registered.
|
|
| 2. |
- Bergling, Karin, et al.
(author)
-
Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR) : Study protocol for a randomized controlled crossover trial
- 2020
-
In: Pilot and Feasibility Studies. - : Springer Science and Business Media LLC. - 2055-5784. ; 6:1
-
Journal article (peer-reviewed)abstract
- Background: It has been estimated that automated peritoneal dialysis (APD) is currently the fastest growing renal replacement therapy in the world. However, in light of the growing number of diabetic patients on peritoneal dialysis (PD), the unwanted glucose absorption during APD remains problematic. Recent results, using an extended 3-pore model of APD, indicated that large reductions in glucose absorption are possible by using optimized bi-modal treatment regimens, having "UF cycles"using a higher glucose concentration, and "Clearance cycles"using a low concentration or, preferentially, no glucose. The present study is designed to test the theoretical prediction of a lower glucose absorption using these novel regimes. Methods: This study is a randomized single-center, open-label, prospective study. Prevalent PD patients between 18 and 75 years old without known catheter problems or recent peritonitis are eligible for inclusion. Patients are allocated to a first treatment session of either standard APD (6 × 2 L 1.36% over 9 h) or optimized APD (7 × 2 L 2.27% + 5 × 2 L 0.1% over 8 h). A second treatment session using the other treatment will be performed in a crossover fashion. Samples of the dialysis fluid will be taken before and after the treatment, and the volume of the dialysate before and after the treatment will be carefully assessed. The primary endpoint is difference in glucose absorption between the optimized and standard treatment. Secondary endpoints are ultrafiltration, sodium removal, Kt/V urea, and Kt/V Creatinine. The study will be closed when a total of 20 patients have successfully completed the interventions or terminated according to interim analysis. A Monte Carlo power analysis shows that the study has 80% power to detect a difference of 10 g (in line with that of theoretical results) in glucose absorption between the two treatments in 10 patients. Discussion: The present study is the first clinical investigation of optimized bi-modal treatments proposed by recent theoretical studies. Trial registration: ClinicalTrials.gov identifier: NCT04017572. Registration date: July 12, 2019, retrospectively registered.
|
|
| 3. |
- Bernhardsson, Susanne, 1958, et al.
(author)
-
Implementation of physical activity on prescription for children with obesity in paediatric health care (IMPA): protocol for a feasibility and evaluation study using quantitative and qualitative methods
- 2022
-
In: Pilot and Feasibility Studies. - : Springer Science and Business Media LLC. - 2055-5784. ; 8:1
-
Journal article (peer-reviewed)abstract
- Background: Physical inactivity is a main cause of childhood obesity which tracks into adulthood obesity, making it important to address early in life. Physical activity on prescription (PAP) is an evidence-based intervention that has shown good effect on physical activity levels in adults, but has not been evaluated in children with obesity. This project aims to evaluate the prerequisites, determinants, and feasibility of implementing PAP adapted to children with obesity and to explore children's, parents', and healthcare providers' experiences of PAP. Methods: In the first phase of the project, healthcare providers and managers from 26 paediatric clinics in Region Vastra Gotaland, Sweden, will be invited to participate in a web-based survey and a subset of this sample for a focus group study. Findings from these two data collections will form the basis for adaptation of PAP to the target group and context. In a second phase, this adapted PAP intervention will be evaluated in a clinical study in a sample of approximately 60 children with obesity (ISO-BMI > 30) between 6 and 12 years of age and one of their parents/legal guardians. Implementation process and clinical outcomes will be assessed pre- and post-intervention and at 8 and 12 months' follow-up. Implementation outcomes are the four core constructs of the Normalization Process Theory; coherence, cognitive participation, collective action, and reflexive monitoring; and appropriateness, acceptability, and feasibility of the PAP intervention. Additional implementation process outcomes are recruitment and attrition rates, intervention fidelity, dose, and adherence. Clinical outcomes are physical activity pattern, BMI, metabolic risk factors, health-related quality of life, sleep, and self-efficacy and motivation for physical activity. Lastly, we will explore the perspectives of children and parents in semi-structured interviews. Design and analysis of the included studies are guided by the Normalization Process Theory. Discussion: This project will provide new knowledge regarding the feasibility of PAP for children with obesity and about whether and how an evidence-based intervention can be fitted and adapted to new contexts and populations. The results may inform a larger scale trial and future implementation and may enhance the role of PAP in the management of obesity in paediatric health care in Sweden.
|
|
| 4. |
- Ekvall Hansson, Eva, et al.
(author)
-
Vestibular rehabilitation for persons with stroke and concomitant dizziness : a pilot study
- 2020
-
In: Pilot and Feasibility Studies. - : Springer Nature. - 2055-5784. ; 6:1
-
Journal article (peer-reviewed)abstract
- Background: Dizziness is common among patients with first time stroke. It affects self-perceived health and is a risk factor for falls. Vestibular rehabilitation (VR) is effective for treating dizziness among various conditions, but the effect of dizziness with origin in the central nervous system is poorly studied.This pilot study of a randomized controlled trial aimed at investigating a vestibular rehabilitation programme among patients with first time stroke and concomitant dizziness. A second aim was to study the feasibility of performing the randomized controlled trial.Methods: The participants were computer generated randomized to either an intervention or a control group. The intervention comprised of four different vestibular rehabilitation exercises, adapted for each patient and usual rehabilitation. The control group received usual rehabilitation without the vestibular rehabilitation exercises. Outcome measures used were The Activities-specific Balance Confidence Scale, the Berg Balance Scale, the Functional Gait Assessment Scale and the EuroQol-5D. Feasibility was studied in terms of recruitment, adherence and retention rates, also as the ability to collect primary and secondary outcomes as well as to find indications of treatment differences.Results: Self-rated health improved for all participants. No other differences between baseline and follow-up were detected neither within nor between groups. Recruitment rate was 23%, adherence to the intervention 90%, retention rate 69% and ability to collect outcome measures 90%. No adverse events occurred.Conclusion: Both the intervention and the control groups improved in self-perceived health. The measures of feasibility were satisfactory in this study, apart from a low recruitment rate.
|
|
| 5. |
- Farrand, Paul, et al.
(author)
-
Behavioural activation written self-help to improve mood, wellbeing and quality of life in people with dementia supported by informal carers (PROMOTE) : a study protocol for a single-arm feasibility study.
- 2016
-
In: Pilot and feasibility studies. - : Springer Science and Business Media LLC. - 2055-5784. ; 2
-
Journal article (peer-reviewed)abstract
- BACKGROUND: Increases in life expectancy have resulted in a global rise in dementia prevalence. Dementia is associated with poor wellbeing, low quality of life and increased incidence of mental health difficulties such as low mood or depression. However, currently, there is limited access to evidence-based psychological interventions for people with dementia experiencing low mood and poor wellbeing. Behavioural activation-based self-help, supported by informal carers and guided by mental health professionals, may represent an effective and acceptable solution.METHODS/DESIGN: The present study is a phase II (feasibility) single-arm trial informed by the Medical Research Council complex interventions research methods framework. Up to 50 dementia participant/informal carer dyads will be recruited from a variety of settings including primary care, dementia-specific health settings and community outreach. People living with dementia will receive behavioural activation-based self-help and be supported by their informal carer who has received training in the skills required to support the self-help approach. In turn, during the use of the intervention, the informal carer will be guided by mental health professionals to help them work through the materials and problem solve any difficulties. Consistent with the objectives of feasibility studies, outcomes relating to recruitment from different settings, employment of different recruitment methods, attrition, data collection procedures, clinical delivery and acceptability of the intervention will be examined. Clinical outcomes for people with dementia (symptoms of depression and quality of life) and informal carers (symptoms of depression and anxiety, carer burden and quality of life) will be measured pre-treatment and at 3 months post-treatment allocation.DISCUSSION: This study will examine the feasibility and acceptability of a novel behavioural activation-based self-help intervention designed to promote wellbeing and improve low mood in people living with dementia, alongside methodological and procedural uncertainties associated with research-related procedures. As determined by pre-specified progression criteria, if research procedures and the new intervention demonstrate feasibility and acceptability, results will then be used to inform the design of a pilot randomised controlled trial (RCT) to specifically examine remaining methodological uncertainties associated with recruitment into a randomised controlled design.TRIAL REGISTRATION: Current Controlled Trials ISRCTN42017211.
|
|
| 6. |
- Frögéli, Elin, et al.
(author)
-
Preventing stress-related ill health among newly registered nurses by supporting engagement in proactive behaviors : development and feasibility testing of a behavior change intervention.
- 2018
-
In: Pilot and Feasibility Studies. - : Springer Science and Business Media LLC. - 2055-5784. ; 4
-
Journal article (peer-reviewed)abstract
- Background: Transitioning into a new professional role is a stressful experience with consequences for mental and physical health, job satisfaction, organizational commitment, and turnover. New registered nurses seem to be at particular risk of developing stress-related ill health during their first years in the profession. Previous research indicates that engagement in proactive behaviors may reduce this risk.Methods: With the work presented in this paper, we aimed to test the feasibility of conducting an evaluation of the effect of a behavior change intervention to prevent stress-related ill health among new registered nurses by supporting their engagement in proactive behaviors. Feasibility objectives included recruitment, randomization, data collection and analysis, participation, acceptability, and deliverability.We tested the feasibility of evaluating the effect of the intervention as part of a transition-to-practice program for new registered nurses using a non-randomized design with one condition. The trial included a sample of 65 new registered nurses who had been working for 6 months or less.Results: The feasibility of conducting a full-scale effect evaluation was confirmed for recruitment, data collection and analysis, participation, and acceptability. It was not possible to randomize participants, but analyses of between-group differences revealed no selection bias. The time of the intervention will need to be extended to ensure the deliverability.Conclusion: With some adjustments in the study design, it is feasible to evaluate the effect of a behavior change intervention to support new registered nurses' engagement in proactive behaviors during their transition into the new profession as part of a transition-to-practice program for new nurses.
|
|
| 7. |
- Gifford, W., et al.
(author)
-
Feasibility and usefulness of a leadership intervention to implement evidence-based falls prevention practices in residential care in Canada
- 2019
-
In: Pilot and Feasibility Studies. - : Springer Science and Business Media LLC. - 2055-5784. ; 5:1
-
Journal article (peer-reviewed)abstract
- Background: Leadership is critical to supporting and facilitating the implementation of evidence-based practices in health care. Yet, little is known about how to develop leadership capacity for this purpose. The aims of this study were to explore the (1) feasibility of delivering a leadership intervention to promote implementation, (2) usefulness of the leadership intervention, and (3) participants' engagement in leadership to implement evidence-based fall prevention practices in Canadian residential care. Methods: We conducted a mixed-method before-and-after feasibility study on two units in a Canadian residential care facility. The leadership intervention was based on the Ottawa model of implementation leadership (O-MILe) and consisted of two workshops and two individualized coaching sessions over 3 months to develop leadership capacity for implementing evidence-based fall prevention practices. Participants (n = 10) included both formal (e.g., managers) and informal (e.g., nurses and care AIDS leaders). Outcome measures were parameters of feasibility (e.g., number of eligible candidates who attended the workshops and coaching sessions) and usefulness of the leadership intervention (e.g., ratings, suggested modifications). We conducted semi-structured interviews guided by the Implementation Leadership Scale (ILS), a validated measure of 12-item in four subcategories (proactive, supportive, knowledgeable, and perseverant), to explore the leadership behaviors that participants used to implement fall prevention practices. We repeated the ILS in a focus group meeting to understand the collective leadership behaviors used by the intervention team. Barriers and facilitators to leading implementation were also explored. Results: Delivery of the leadership intervention was feasible. All participants (n = 10) attended the workshops and eight participated in at least one coaching session. Workshops and coaching were rated useful (≥ 3 on a 0-4 Likert scale where 4 = highly useful) by 71% and 86% of participants, respectively. Participants rated the O-MILe subcategories of supportive and perseverant leadership highest for individual leadership, whereas supportive and knowledgeable leadership were rated highest for team leadership. Conclusions: The leadership intervention was feasible to deliver, deemed useful by participants, and fostered engagement in implementation leadership activities. Study findings highlight the complexity of developing implementation leadership and modifications required to optimize impact. Future trials are now required to test the effectiveness of the leadership intervention on developing leadership for implementing evidence-based practices. © The Author(s). 2019.
|
|
| 8. |
- Gould, Rebecca, et al.
(author)
-
Acceptance and Commitment Therapy for people living with motor neuron disease : an uncontrolled feasibility study
- 2023
-
In: Pilot and Feasibility Studies. - : Springer Nature. - 2055-5784. ; 9
-
Journal article (peer-reviewed)abstract
- Background: Motor neuron disease (MND) is a fatal, progressive neurodegenerative disease that causes progressive weakening and wasting of limb, bulbar, thoracic and abdominal muscles. Clear evidence-based guidance on how psychological distress should be managed in people living with MND (plwMND) is lacking. Acceptance and Commitment Therapy (ACT) is a form of psychological therapy that may be particularly suitable for this population. However, to the authors' knowledge, no study to date has evaluated ACT for plwMND. Consequently, the primary aim of this uncontrolled feasibility study was to examine the feasibility and acceptability of ACT for improving the psychological health of plwMND.Methods: PlwMND aged >= 18 years were recruited from 10 UK MND Care Centres/Clinics. Participants received up to 8 one-to-one ACT sessions, developed specifically for plwMND, plus usual care. Co-primary feasibility and acceptability outcomes were uptake (>= 80% of the target sample [N = 28] recruited) and initial engagement with the intervention (>= 70% completing >= 2 sessions). Secondary outcomes included measures of quality of life, anxiety, depression, disease-related functioning, health status and psychological flexibility in plwMND and quality of life and burden in caregivers. Outcomes were assessed at baseline and 6 months.Results: Both a priori indicators of success were met: 29 plwMND (104%) were recruited and 76% (22/29) attended >= 2 sessions. Attrition at 6-months was higher than anticipated (8/29, 28%), but only two dropouts were due to lack of acceptability of the intervention. Acceptability was further supported by good satisfaction with therapy and session attendance. Data were possibly suggestive of small improvements in anxiety and psychological quality of life from baseline to 6 months in plwMND, despite a small but expected deterioration in disease-related functioning and health status.Conclusions: There was good evidence of acceptability and feasibility. Limitations included the lack of a control group and small sample size, which complicate interpretation of findings. A fully powered RCT to evaluate the clinical and cost-effectiveness of ACT for plwMND is underway.
|
|
| 9. |
|
|
| 10. |
|
|
