scholarly journals Planning implementation and scale-up of physical activity interventions for people with walking difficulties: study protocol for the process evaluation of the ComeBACK trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Siobhan Wong ◽  
Leanne Hassett ◽  
Harriet Koorts ◽  
Anne Grunseit ◽  
Allison Tong ◽  
...  

Abstract Background There is currently little evidence of planning for real-world implementation of physical activity interventions. We are undertaking the ComeBACK (Coaching and Exercise for Better Walking) study, a 3-arm hybrid Type 1 randomised controlled trial evaluating a health coaching intervention and a text messaging intervention. We used an implementation planning framework, the PRACTical planning for Implementation and Scale-up (PRACTIS), to guide the process evaluation for the trial. The aim of this paper is to describe the protocol for the process evaluation of the ComeBACK trial using the framework of the PRACTIS guide. Methods A mixed methods process evaluation protocol was developed informed by the Medical Research Council (MRC) guidance on process evaluations for complex interventions and the PRACTIS guide. Quantitative data, including participant questionnaires, health coach and administrative logbooks, and website and text message usage data, is being collected over the trial period. Semi-structured interviews and focus groups with trial participants, health coaches and health service stakeholders will explore expectations, factors influencing the delivery of the ComeBACK interventions and potential scalability within existing health services. These data will be mapped against the steps of the PRACTIS guide, with reporting at the level of the individual, provider, organisational and community/systems. Quantitative and qualitative data will elicit potential contextual barriers and facilitators to implementation and scale-up. Quantitative data will be reported descriptively, and qualitative data analysed thematically. Discussion This process evaluation integrates an evaluation of prospective implementation and scale-up. It is envisaged this will inform barriers and enablers to future delivery, implementation and scale-up of physical activity interventions. To our knowledge, this is the first paper to describe the application of PRACTIS to guide the process evaluation of physical activity interventions. Trial registration Australian and New Zealand Clinical Trials Registry (ANZCTR) Registration date: 10/12/2018.

2019 ◽  
Author(s):  
Kareem Khan ◽  
Chris Hollis ◽  
Charlotte L Hall ◽  
E Bethan Davies ◽  
David Mataix-Cols ◽  
...  

Abstract Background Process evaluations are an important component in the interpretation and understanding of outcomes in trials. The ‘Online Remote Behavioural Intervention for Tics’ (ORBIT) study is a randomized controlled trial evaluating the effectiveness of an internet delivered behavioural intervention (called BIP TIC) compared to an internet delivered education program aimed at children and young people with tics. A process evaluation will be undertaken alongside the main trial to determine precisely how the behavioural intervention works and ascertain whether, and if so, how, the intervention could be successfully implemented in standard clinical practice. This protocol paper describes the rationale, aims, and methodology of the ORBIT trial process evaluation. Methods The process evaluation will use a mixed-methods design following the UK Medical Research Council’s 2015 guidelines, comprising of both quantitative and qualitative data collection. This will include: analyzing data usage of participants in the intervention arm; purposively sampled, semi-structured interviews of parents and children, therapists and supervisors, and referring clinicians of the ORBIT trial, as well as analysis of qualitative comments input into the online therapy platform by participants at the end of treatment. Qualitative data will be analyzed thematically. Quantitative and qualitative data will be integrated in a triangulation approach, to provide an understanding of how the intervention works, and what resources are needed for effective implementation, uptake and use in routine clinical care. Discussion This process evaluation will explore the experiences of participants, therapists and supervisors, and referring clinicians of a complex online intervention. By contextualising trial efficacy results, this will help understand how and if the intervention worked and what may be required to sustain the implementation of the treatment long-term. The findings will also aid in our understanding of factors that can affect the success of complex interventions. This will enable future researchers developing online behavioural interventions for children and young people with mental health and neurological disorders to gain invaluable information from this process evaluation.


2019 ◽  
Author(s):  
Kareem Khan ◽  
Chris Hollis ◽  
Charlotte L Hall ◽  
E Bethan Davies ◽  
David Mataix-Cols ◽  
...  

Abstract Background Process evaluations are an important component in the interpretation and understanding of outcomes in trials. The ‘Online Remote Behavioural Intervention for Tics’ (ORBIT) study is a randomized controlled trial evaluating the effectiveness of an internet delivered behavioural intervention (called BIP TIC) compared to an internet delivered education program aimed at children and young people with tics. A process evaluation will be undertaken alongside the main trial to determine precisely how the behavioural intervention works and ascertain whether, and if so, how, the intervention could be successfully implemented in standard clinical practice. This protocol paper describes the rationale, aims, and methodology of the ORBIT trial process evaluation. Methods The process evaluation will use a mixed-methods design following the UK Medical Research Council’s 2015 guidelines, comprising of both quantitative and qualitative data collection. This will include: analyzing data usage of participants in the intervention arm; purposively sampled, semi-structured interviews of parents and children, therapists and supervisors, and referring clinicians of the ORBIT trial, as well as analysis of qualitative comments input into the online therapy platform by participants at the end of treatment. Qualitative data will be analyzed thematically. Quantitative and qualitative data will be integrated in a triangulation approach, to provide an understanding of how the intervention works, and what resources are needed for effective implementation, uptake and use in routine clinical care. Discussion This process evaluation will explore the experiences of participants, therapists and supervisors, and referring clinicians of a complex online intervention. By contextualising trial efficacy results, this will help understand how and if the intervention worked and what may be required to sustain the implementation of the treatment long-term. The findings will also aid in our understanding of factors that can affect the success of complex interventions. This will enable future researchers developing online behavioural interventions for children and young people with mental health and neurological disorders to gain invaluable information from this process evaluation.


2019 ◽  
Vol 2 ◽  
pp. 20 ◽  
Author(s):  
Karen Kyne ◽  
Caroline McCarthy ◽  
Bridget Kiely ◽  
Susan M. Smith ◽  
Barbara Clyne ◽  
...  

Background: Multimorbidity (the presence of two or more chronic conditions) is associated with poorer health outcomes, particularly for patients with significant polypharmacy (≥15 medications), due to the higher risk of adverse events and drug interactions. The SPPiRE study will assess the effectiveness of a complex intervention to support general practitioners (GPs) to reduce potentially inappropriate prescribing and consider deprescribing in older people with multimorbidity and significant polypharmacy. The aim of the SPPiRE process evaluation is to understand how and why the intervention is effective or ineffective and to explore the potential for system wide implementation of the intervention using the Medical Research Council general themes of context, implementation and mechanism of impact. Methods: The SPPiRE study is a clustered randomised controlled trial (RCT), aiming to recruit 55 general practices and 400 patients (≥65 years) on ≥15 medications throughout the Republic of Ireland. This mixed-methods process evaluation of the SPPiRE study will integrate both quantitative and qualitative data. Quantitative data will be collected on use of the intervention elements and from GP questionnaires. Qualitative data will be collected from semi-structured telephone interviews with all intervention GPs and a purposeful sample of patients from intervention practices. The topic guide will explore barriers and facilitators to participation and implementation of the intervention. Quantitative data will be analysed using descriptive statistics. Interviews will be transcribed and analysed using thematic analysis. Quantitative and qualitative data will be then be integrated. Discussion: The SPPiRE cluster RCT will provide evidence regarding the effectiveness and practicability of delivering a structured medication review in reducing polypharmacy and potentially inappropriate prescribing for patients with multimorbidity. This process evaluation will provide information on how the intervention was implemented, how it was or was not effective and the potential for a system wide implementation. Trial registration: ISRCTN 12752680, registration: 20/10/2016


2020 ◽  
Vol 2 ◽  
pp. 20 ◽  
Author(s):  
Karen Kyne ◽  
Caroline McCarthy ◽  
Bridget Kiely ◽  
Susan M. Smith ◽  
Barbara Clyne ◽  
...  

Background: Multimorbidity (the presence of two or more chronic conditions) is associated with poorer health outcomes, particularly for patients with significant polypharmacy (≥15 medications), due to the higher risk of adverse events and drug interactions. The SPPiRE study will assess the effectiveness of a complex intervention to support general practitioners (GPs) to reduce potentially inappropriate prescribing and consider deprescribing in older people with multimorbidity and significant polypharmacy. The aim of the SPPiRE process evaluation is to understand how and why the intervention is effective or ineffective and to explore the potential for system wide implementation of the intervention using the Medical Research Council general themes of context, implementation and mechanism of impact. Methods: The SPPiRE study is a clustered randomised controlled trial (RCT), aiming to recruit 55 general practices and 400 patients (≥65 years) on ≥15 medications throughout the Republic of Ireland. This mixed-methods process evaluation of the SPPiRE study will integrate both quantitative and qualitative data. Quantitative data will be collected on use of the intervention elements and from GP questionnaires. Qualitative data will be collected from semi-structured telephone interviews with all intervention GPs and a purposeful sample of patients from intervention practices. The topic guide will explore barriers and facilitators to participation and implementation of the intervention. Quantitative data will be analysed using descriptive statistics. Interviews will be transcribed and analysed using thematic analysis. Quantitative and qualitative data will be then be integrated. Discussion: The SPPiRE cluster RCT will provide evidence regarding the effectiveness and practicability of delivering a structured medication review in reducing polypharmacy and potentially inappropriate prescribing for patients with multimorbidity. This process evaluation will provide information on how the intervention was implemented, how it was or was not effective and the potential for a system wide implementation. Trial registration: ISRCTN 12752680, registration: 20/10/2016


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Aymen El Masri ◽  
Gregory S. Kolt ◽  
Emma S. George

Abstract Background Despite being one of the largest migrant groups in Australia, few physical activity interventions exist for Arab-Australians. The primary aim of this study was to test the feasibility and acceptability of a 12-week culturally tailored physical activity intervention for Arab-Australian women. Methods This study used a single-group pretest–posttest design, and was informed by extensive formative research and consultation involving the Arab-Australian community. Participants were insufficiently active Arab-Australian women aged 35–64 with no current illness or injury that would limit physical activity participation. The intervention comprised 6 face-to-face physical activity and education sessions over 12 weeks. The intervention was conducted at 2 separate intervention sites in Western Sydney, Australia. Feasibility outcomes included recruitment, session attendance, and retention. The acceptability of the intervention was assessed through a process evaluation questionnaire completed post-intervention. Accelerometers and the short-form International Physical Activity Questionnaire were used to measure physical activity at baseline and post-intervention. Descriptive statistics were used for feasibility and acceptability outcomes, and changes in physical activity were examined using Wilcoxon signed-rank tests. Results Of the 53 women who were contacted or expressed interest, 22 were eligible and enrolled in the study. Participants were primarily recruited through direct contact by Arab-Australian community workers and by word-of-mouth. Average session attendance was 63% and the retention rate post-intervention was 68%. The culturally-related intervention components, such as the appropriateness of content, and women-only setting, were rated highly favourably (4.33 to 4.87/5). General intervention elements, such as the face-to-face delivery, knowledge and approachability of facilitators, and session structure, were also rated favourably (4.33 to 4.93/5), and the lowest scored item was the intervention session frequency (3.2/5). There were no statistically significant changes in physical activity post-intervention. Conclusions The findings from this study highlighted factors related to recruitment and delivery that need to be considered when developing physical activity interventions for Arab-Australian women. Further research is required using a larger sample and a randomised controlled trial design to examine the longer-term impact on physical activity, and to also examine ways of increasing intervention engagement and retention among Arab-Australian women. Trial Registration: ANZCTR, ACTRN12618001392257. Registered 20 August 2018, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375636.


2018 ◽  
Vol 4 (5) ◽  
pp. 437-447
Author(s):  
Deni Susyanti ◽  
Dewi Elizadiani Suza ◽  
Yesi Ariani

Background: Patients with congestive heart failure need a comprehensive rehabilitative program to restore post-attack physical ability and prevent re-attacks, therefore, it is necessary to develop physical activity protocols for these patients. Objective: This study aims to develop physical activity protocols for patients with congestive heart failure in the inpatient wards of the Level II Putri Hijau Hospital, Indonesia. Methods: This was an action research with 3 cycles consisting of four stages, namely: (1) reconnaissance, (2) planning, (3) action and observation, and (4) reflection. Data were collected quantitatively and qualitatively. Qualitative data were collected using in-depth interview, focus group discussion, and self-report, while quantitative data were collected using nursing knowledge questionnaire to 35 nurses selected using total sampling, and self-efficacy questionnaire about physical activity exercise to 9 patients with congestive heart failure selected using accidental sampling. Qualitative data were analyzed using content analysis, while quantitative data using descriptive statistical test. Results: Findings showed the completed compilation of physical activity protocols for patients with congestive heart failure. The results of observation showed a decrease in blood pressure of patients with congestive heart failure on the average of 3.12 mmHg after given physical activity protocol by nurses. Conclusion: The physical activity protocols for patients with congestive heart failure have been developed, and it has an impact on the increase of nurses' knowledge concerning physical activity exercise for CHF patients as well as the improvement of patients' self-efficacy or self-confidence in doing the physical activities.


2018 ◽  
Vol 27 (3) ◽  
pp. 654-664 ◽  
Author(s):  
Delfien Van Dyck ◽  
Sara D’Haese ◽  
Jolien Plaete ◽  
Ilse De Bourdeaudhuij ◽  
Benedicte Deforche ◽  
...  

2020 ◽  
Vol 9 (3) ◽  
pp. 163
Author(s):  
Oğuz Kaan Esentürk ◽  
Nuri Berk Güngör

The aim of this study was to investigate the effect of peer-mediated adaptive physical activity program on problem behaviors of mentally handicapped students. Eight mentally handicapped students and eight peer students with normal development participated in this study, which was designed according to a sequential descriptive design. In the research, peer education program was applied to the peer students in line with the skills expected to be exhibited during the practices. In the study, Problem Behavior Sub-Scale (PBS), which is one of the subscales of Social Skills Rating System (SSRS) developed by Gresham and Elliot (1990) and Turkish adaptation by Sucuoglu and Ozokcu (2005) was used as a quantitative data collection tool. As a qualitative data collection tool, semi-structured interview form was used. The Friedman test was used to analyze the quantitative data, and Wilcoxon Signs test was used to determine the source of the difference. Significance value was determined as 0.05. In the analysis of qualitative data, content analysis was applied. The quantitative findings of the study showed that the peer-mediated APA program was effective on the problem behaviors of mentally handicapped students and that the skills acquired as a result of the practice were maintained by the children three weeks after the completion of the practices. In the qualitative findings, the teachers stated that after the peer-mediated APA program, there were positive developments in the ability of mentally handicapped students to experience push-pull, touch discomfort, fear, trust, power control with their peers and to act in accordance with the instructions. The obtained qualitative and quantitative findings showed that peer mediated APA program had positive effects on the problem behaviors of mentally handicapped students.


2020 ◽  
Vol 12 (12) ◽  
pp. 4904
Author(s):  
Nan Yang ◽  
Gerbrand van Hout ◽  
Loe Feijs ◽  
Wei Chen ◽  
Jun Hu

With the development of sensing technology and the popularization of quantified-self devices, there are increasing types of health-related data that can be sensed, visualized and presented to the user. However, most existing quantified-self applications are designed to support self-management and self-reflection; only a few studies so far have investigated the social aspect of quantified-self data. In this study, we investigated the social role of quantified-self data by introducing the design and evaluation of SocialBike—a digitally augmented bicycle that aims to increase the user’s intrinsic motivation in physical activity through on-site quantified-self data sharing. We conducted a controlled experiment on a cycling simulation system. Two forms of SocialBike’s on-bike display were evaluated with 36 participants. We used the Intrinsic Motivation Inventory to collect quantitative data about users’ intrinsic motivation in physical activity; the cycling simulation system recorded quantitative data about user behavior. Qualitative data was collected through semi-structured interviews. We conducted paired sample t-test to analyze both types of quantitative data; qualitative data were analyzed by the method of thematic analysis. The results show that SocialBike’s front display significantly increased users’ intrinsic motivation in physical activity. A total of nine themes were identified from the qualitative analysis, providing supplementary explanations for the quantitative results and additional insights into the overall design.


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