| 1. |
- Bernhardsson, Susanne, 1958, et al.
(författare)
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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
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Ingår i: Pilot and Feasibility Studies. - : Springer Science and Business Media LLC. - 2055-5784. ; 8:1
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Tidskriftsartikel (refereegranskat)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.
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| 2. |
- Gifford, W., et al.
(författare)
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Feasibility and usefulness of a leadership intervention to implement evidence-based falls prevention practices in residential care in Canada
- 2019
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Ingår i: Pilot and Feasibility Studies. - : Springer Science and Business Media LLC. - 2055-5784. ; 5:1
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Tidskriftsartikel (refereegranskat)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.
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| 3. |
- Mukka, Sebastian, et al.
(författare)
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A cohort study comparing internal fixation for undisplaced versus hip arthroplasty for displaced femoral neck fracture in the elderly : a pilot study for a clinical trial
- 2020
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Ingår i: Pilot and Feasibility Studies. - : Springer Nature. - 2055-5784. ; 6
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: The literature regarding undisplaced femoral neck fractures (FNF) is sparse. The aim of this prospective feasibility study is to compare the clinical outcome after undisplaced FNF treated with internal fixation (IF) and displaced FNF treated with hip arthroplasty. We hypothesized that hip arthroplasty would give a lower incidence of reoperations.Methods: A total of 235 patients were included with a median age of 84 years (range 65-99). A consecutive series of 65 patients with undisplaced FNF were treated with IF, and 170 patients with displaced FNF were treated with either a total hip arthroplasty or a hemiarthroplasty. Follow-up interviews were conducted at 1 year using the Harris Hip Score (HHS), WOMAC, and pain numeric rating scale (PNRS). The minimum follow-up time was 22 months. There was no difference in baseline data between the groups.Results: Nineteen (8%) hips required reoperation at least once at a mean of 6 months (range 0-35). The rate of reoperation was higher in the IF group compared to the hip arthroplasty group (13.8% vs. 5.9%, 95% CI 0.9-6.4). The overall 1-year and 2-year mortality was 28% and 40%, respectively, with no difference between the groups. The most common reasons for reoperations in the IF group were non-union and avascular necrosis, and 6 patients were treated with hip or excision arthroplasty. In the arthroplasty group, the most common indications were deep infection and dislocation. We did not find any differences between the groups in terms of HHS, WOMAC, and PNRS.Conclusions: In this feasibility study, we found no differences in patient-reported outcomes between the groups although IF required a higher rate of reoperations. Further randomized trials are needed to establish the optimal treatment of undisplaced FNF in the elderly.Trial registration: ClinicalTrial.org, NCT03392285. Retrospectively registered on 5 February 2018.
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| 4. |
- Murphy, Patrick J., et al.
(författare)
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The CHARMS pilot study: a multi-method assessment of the feasibility of a sexual counselling implementation intervention in cardiac rehabilitation in Ireland
- 2018
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Ingår i: Pilot and Feasibility Studies. - : BioMed Central. - 2055-5784. ; 4
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Tidskriftsartikel (refereegranskat)abstract
- Many people living with cardiovascular disease (CVD) are affected by sexual problems associated with the condition. International guidelines recommend all patients with CVD should receive sexual counselling, yet this is rarely provided by health professionals. The current study piloted the Cardiac Health and Relationship Management and Sexuality (CHARMS) intervention, a complex multi-level intervention designed to increase the implementation of sexual counselling guidelines in hospital-based cardiac rehabilitation (CR) in Ireland.
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| 5. |
- Pedersen, Britt Staevnsbo, et al.
(författare)
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Feasibility and implementation fidelity of a co-designed intervention to promote in-hospital mobility among older medical patients - the WALK-Copenhagen project (WALK-Cph)
- 2022
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Ingår i: Pilot and Feasibility Studies. - : BMC. - 2055-5784. ; 8:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: Mobility interventions can prevent functional decline among older patients, but implementation of such interventions may be complicated by barriers in the clinical setting. The WALK-Copenhagen project (WALK-Cph) is aimed at promoting a 24-h mobility among older medical patients during hospitalization. The WALK-Cph intervention was co-designed by researchers and stakeholders to tailor the intervention to the clinical context. The aim of this study was to investigate the feasibility and implementation fidelity of the WALK-Cph intervention before evaluating clinical effectiveness in a randomized controlled trial (ClinicalTrials.gov NCT03825497). Methods: The WALK-Cph intervention consisted of six components: a welcome folder explaining the importance of in-hospital activity, a WALK-plan prescribing up to three daily walking sessions during and after hospitalization, a WALK-path in the hallway that patients were motivated to use daily, exercise posters in the hallways and bedrooms, self-service on beverages and clothes, and discharge with a WALK-plan. The present study reports on phase 2 of WALK-Cph and consists of a feasibility and a fidelity component. The study was conducted at the two WALK-Cph intervention departments after the initiation of the WALK-Cph intervention. A cohort of older medical patients (+65) was recruited for the feasibility study to assess recruitment and data collection procedures and the method for assessment of activity. Simultaneously, implementation fidelity was assessed by observing clinical practice and intervention delivery at the intervention departments. Results: A feasibility cohort of 48 patients was included. Inclusion was considered feasible with recruitment rates between 62% and 70% of all eligible patients. Also, data collection was conducted without obstacles, and all patients accepted to wear activity monitors. The fidelity observations showed that three of the six intervention components were partially implemented as planned whereas three components were not implemented as planned. Conclusion: The WALK-Cph intervention was found feasible, and although the intervention was not implemented with fidelity, the level of fidelity was considered sufficient to continue with further testing of the WALK-Cph intervention in a large-scale trial.
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| 6. |
- Santos, Gabrielle Cecile, et al.
(författare)
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Feasibility, acceptability, and outcome responsiveness of the SYMPERHEART intervention to support symptom perception in persons with heart failure and their informal caregivers : a feasibility quasi-experimental study
- 2023
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Ingår i: Pilot and Feasibility Studies. - : BioMed Central (BMC). - 2055-5784. ; 9:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: Symptom perception is an important process of heart failure (HF) self-care that persons with HF need in order to master self-care management. It also leads to better patient outcomes. Symptom perception consists of body observation and analysis, which are both challenging. We aimed to test the feasibility, acceptability, and outcome responsiveness of a novel intervention (SYMPERHEART) delivered to persons with HF with their informal caregiver.Methods: We designed SYMPERHEART as a complex evidence-informed education and support intervention targeting body observation and analysis. We conducted a feasibility quasi-experimental study with a single group pre-post-test design. We included three subsamples: persons with HF receiving home-based care, their informal caregivers exposed to SYMPERHEART, and home-care nurses who delivered SYMPERHEART during 1 month. We assessed feasibility by recruitment time, time to deliver SYMPERHEART, eligibility rate, and intervention fidelity. We assessed acceptability by consent rate, retention rate, persons with HF engagement in body observation, and treatment acceptability. Outcome responsiveness was informed by patient-reported (PRO) and clinical outcomes: HF self-care and the informal caregivers' contribution to HF self-care, perception of HF symptom burden, health status, caregivers' burden, and HF events. We performed descriptive analyses for quantitative data and calculated Cohen's d for PROs. A power analysis estimated the sample size for a future full-scale effectiveness study.Results: We included 18 persons with HF, 7 informal caregivers, and 9 nurses. Recruitment time was 112.6 h. The median time to deliver SYMPERHEART for each participant was 177.5 min. Eligibility rate was 55% in persons with HF. Intervention fidelity revealed that 16 persons with HF were exposed to body observation and analysis. Consent and retention rates in persons with HF were 37.5% and 100%, respectively. Participants engaged actively in symptom and weight monitoring. Treatment acceptability scores were high. Symptom perception and informal caregivers' contribution to symptom perception were found to be responsive to SYMPERHEART. We estimate that a sample size of 50 persons with HF would be needed for a full-scale effectiveness study.Conclusions: SYMPERHEART was found to be feasible and acceptable. This feasibility study provides information for a subsequent effectiveness study.Trial registrationISRCTN. ISRCTN18151041, retrospectively registered on 4 February 2021, ICTRP Search Portal.
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| 7. |
- Schafer-Keller, Petra, et al.
(författare)
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A multicomponent complex intervention for supportive follow-up of persons with chronic heart failure: a randomized controlled pilot study (the UTILE project)
- 2023
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Ingår i: Pilot and Feasibility Studies. - : BMC. - 2055-5784. ; 9:1
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Tidskriftsartikel (refereegranskat)abstract
- Background Heart failure (HF) is a progressive disease associated with a high burden of symptoms, high morbidity and mortality, and low quality of life (QoL). This study aimed to evaluate the feasibility and potential outcomes of a novel multicomponent complex intervention, to inform a future full-scale randomized controlled trial (RCT) in Switzerland. Methods We conducted a pilot RCT at a secondary care hospital for people with HF hospitalized due to decompensated HF or with a history of HF decompensation over the past 6 months. We randomized 1:1; usual care for the control (CG) and intervention group (IG) who received the intervention as well as usual care. Feasibility measures included patient recruitment rate, study nurse time, study attrition, the number and duration of consultations, intervention acceptability and intervention fidelity. Patient-reported outcomes included HF-specific self-care and HF-related health status (KCCQ-12) at 3 months follow-up. Clinical outcomes were all-cause mortality, hospitalization and days spent in hospital. Results We recruited 60 persons with HF (age mean = 75.7 years, +/- 8.9) over a 62-week period, requiring 1011 h of study nurse time. Recruitment rate was 46.15%; study attrition rate was 31.7%. Follow-up included 2.14 (mean, +/- 0.97) visits per patient lasting a total of 166.96 min (mean, +/- 72.55), and 3.1 (mean, +/- 1.7) additional telephone contacts. Intervention acceptability was high. Mean intervention fidelity was 0.71. We found a 20-point difference in mean self-care management change from baseline to 3 months in favour of the IG (Cohens d = 0.59). Small effect sizes for KCCQ-12 variables; less IG participants worsened in health status compared to CG participants. Five deaths occurred (IG = 3, CG = 2). There were 13 (IG) and 18 (CG) all-cause hospital admissions; participants spent 8.90 (median, IQR = 9.70, IG) and 15.38 (median, IQR = 18.41, CG) days in hospital. A subsequent full-scale effectiveness trial would require 304 (for a mono-centric trial) and 751 participants (for a ten-centre trial) for HF-related QoL (effect size = 0.3; power = 0.80, alpha = 0.05). Conclusion We found the intervention, research methods and outcomes were feasible and acceptable. We propose increasing intervention fidelity strategies for a full-scale trial. Trial registration ISRCTN10151805, retrospectively registered 04/10/2019.
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| 8. |
- Wall, Hakan, et al.
(författare)
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The evaluation of a brief ICBT program with therapist support for individuals with gambling problems in the context of a gambling helpline: a randomized pilot trial
- 2023
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Ingår i: Pilot and Feasibility Studies. - : BMC. - 2055-5784. ; 9:1
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Tidskriftsartikel (refereegranskat)abstract
- Background and aims Gambling helplines are a natural way of first contact for individuals with gambling problems. However, few studies have evaluated the feasibility and effectiveness of brief interventions in a gambling helpline. To reduce this knowledge gap, this study evaluated the feasibility of an online cognitive behavioral therapy (ICBT) program in the context of a gambling helpline as a first step towards a full-scale RCT. Design This is a two-group parallel randomized controlled pilot trial where the participants were randomized to either a brief four-module ICBT program (n = 22) or a control group (n = 21). Participants were followed up weekly during the intervention, post intervention, and 6 weeks upon completion of intervention. Participants A total of 43 self-identified individuals with gambling problems (scoring 3 or more on the Problem Gambling Severity Index) were recruited via the Swedish national gambling helpline, 59% females, mean age 43.7 years. Measurements Feasibility of the procedure and intervention (i.e., recruitment pace, attrition, program engagement, and satisfaction) were the primary outcomes; treatment effect (net gambling losses) was the secondary outcome. Results Approximately 2 participants per week were randomized, and retention was low, with 47% lost to follow-up at the 6-week follow-up time-point. Most participants engaged in the online modules (86%) and rated their overall satisfaction with the program as high (7.5 out of 10). Both groups decreased their weekly gambling losses at both follow-up time-points, but the between-group comparisons were inconclusive. Conclusion It is not advisable to conduct a full-scale RCT based on the results from this pilot study. Future studies in a gambling helpline should consider interventions that are more suited to be incorporated in a gambling helpline and identify ways to increase participant engagement.
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