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Study Protocol

Exploring the perspectives of stroke survivors and healthcare professionals on the use of mobile health to promote physical activity: A qualitative study protocol

[version 1; peer review: 2 approved]
PUBLISHED 06 Jun 2019
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Abstract

Background: Physical inactivity is both the second-highest population attributable risk factor for and a common consequence of stroke. Despite well-documented health benefits associated with physical activity, its levels typically remain below recommended guidelines in stroke survivors. Consequently, calls have been made for novel interventions targeting the promotion of physical activity in stroke survivors. Mobile health is an emerging field which can offer personalised health interventions through mobile and wireless technology. However, a paucity of research has focused on mobile health to promote physical activity in stroke survivors and, more broadly, this field has been criticised for not incorporating the views of stakeholders. This study aims to explore the perspectives of stroke survivors and healthcare professionals on the development of a mobile health intervention for the promotion of physical activity.
Methods: The current study will employ a qualitative descriptive approach using separate, semi-structured focus groups for two key stakeholder groups. Community-dwelling stroke survivors will be recruited through an early supported discharge service for acute stroke and stroke support groups. Healthcare professionals will be recruited through the same early supported discharge service, relevant professional bodies and Twitter. The final number of focus groups will depend on data saturation. Thematic analysis will be conducted using NVivo 12 and findings will be reported in accordance with the Consolidated Criteria for Reporting Qualitative Studies.
Conclusion: This study was granted ethical approval from the HSE Mid-Western Regional Hospital Research Ethics Committee and the Faculty of Education and Health Sciences Research Ethics Committee at the University of Limerick. Output will consist of recommendations for the development of a mobile health intervention aimed at the promotion of physical activity in stroke survivors. Findings will be disseminated locally through presentations at stroke support groups, as well as internationally through academic conferences and peer-reviewed journals.

Keywords

Stroke, physical activity, mHealth, qualitative

Introduction

Stroke is a leading cause of death1 and increase in disability-adjusted life years globally2. Developed countries spend an estimated 3% of their healthcare budgets on stroke3, a key driver of which is rehabilitation services4. Cost of stroke rehabilitation is explained in part by the complex way in which stroke can present, affecting function and reducing participation across a variety of domains5, including physical activity (PA).

PA is an overarching term which describes “any bodily movement produced by skeletal muscles that results in energy expenditure”6, whereas exercise is a subsegment of PA described as “planned, structured, and repetitive and has as a final or an intermediate objective the improvement or maintenance of physical fitness”6. Despite the inclusion of both PA and exercise in primary and secondary prevention guidelines7, levels of PA in stroke survivors, including those who are ambulatory, remain low8. A variety of methods are available for measuring PA, including self-report, direct observation, pedometry and accelerometery9, though objective measures offer greater advantage over self-reported PA data which is frequently overestimated10,11. Meta-analytic evidence demonstrates that daily step count in stroke survivors is estimated at 4355.28. This falls below guidelines for the general population (10000 steps)12 and for adults with chronic illness (6500–8500 steps)13.

Regular and moderate-to-high levels of PA are associated with reduced risk of stroke14 and a large, multi-site case-control study has demonstrated that PA is the second-highest population-attributable risk factor for stroke15. Stroke survivors are at a greater risk of stroke than the general population, with almost a quarter of patients experiencing a recurrent stroke16. The pooled cumulative risk of recurrent stroke is estimated at 11.1% (95% CI, 9.0 –13.3) at one year and 39.2% (95% CI, 27.2–51.2) at ten years post stroke17. Recurrent strokes are associated with poorer clinical outcomes, including level of disability and mortality rate, and greater healthcare costs18. Extrapolating the benefits of increasing PA and exercise in the general population to stroke survivors suggests that PA and exercise interventions delivered through stroke rehabilitation may reduce the risk of recurrent stroke19.

Interest in PA by key stakeholders has also been noted. A priority-setting partnership comprised of stroke survivors, caregivers and healthcare professionals (HCPs), using the James Lind Alliance methodology, reached consensus on ten key shared priorities for future research relating to life after stroke. The final priority focused on exploring the role that exercise and fitness programs can play in improving function, quality of life and reducing risk of subsequent stroke20. Further, several of the priorities identified focused on improving stroke-related deficits, including cognition, fatigue, gait, balance and mobility20, each of which, it has been previously argued, has the potential to be improved through exercise and PA21,22.

However, a review by Billinger and colleagues7 concluded that education and tailored exercise counselling have demonstrated only mixed efficacy in increasing PA in stroke survivors. The authors of the review recommend that novel strategies using new technology (e.g. mobile applications (apps) and wearable devices) should be capitalised on in future PA interventions for stroke survivors7. This recommendation with regards incorporating apps and wearables into PA interventions for stroke survivors has been made elsewhere23 and mirrors recommendations from the PA literature more broadly24.

Mobile health (mHealth) is a developing field which aims to promote health through the use of wireless and mobile technology25 and whose ascent is linked to increasing smartphone ownership globally26. It has been recognised for its potential to deliver novel healthcare interventions27 and to bridge systemic gaps25 while offering a level of support not previously available to patients28. Noteworthy for PA interventions, mHealth can also incorporate accelerometery29 which facilitates the capacity for both self-monitoring and objective monitoring by others. While mHealth apps have been deployed in diabetes self-management30 and cardiac rehabilitation31 and have been recommended for use in stroke services32, there has been a paucity of research conducted on the use of mHealth to promote PA in stroke rehabilitation23,33. A recent open-label pilot study on 24 community-dwelling stroke survivors assigned participants to either a mHealth intervention (n=16) or a control group (n=8)34. The intervention group used an existing PA app which had been modified through co-design sessions involving stroke survivors. The findings from the six-week intervention included a significant increase in daily steps, as well as a positive effect on walking time and a reduction in self-reported fatigue34.

Despite the promising findings detailed above, mHealth apps aimed at promoting PA have generally been criticised for their limited use of theory, incorporating only a limited number of behaviour change techniques (BCTs)3537 and with their implementation being described as “narrow”35 and “far from optimal”37 . Further, mHealth in general has been criticised for providing over-engineered solutions without incorporating the views of end-users38.

The Medical Research Council’s (MRC) guidelines for developing complex health interventions emphasises the importance of identifying the existing evidence base39. To this end, a systematic review and meta-synthesis by Carter and colleagues40 was conducted to explore the experience of adults using mHealth for the promotion of PA. However, it identified no studies focusing on the experiences of stroke survivors. Qualitative research is noted to be essential in developing all stages of a digital health intervention41 and reporting guidelines by the World Health Organization describe end-user feedback as an important element in developing mHealth interventions25. To further advance the evidence base for an intervention to promote PA in stroke survivors, the current study will explore the perspectives of two key stakeholder groups: stroke survivors and HCPs.

Methods

Design

This research will employ a qualitative design to explore stakeholder perspectives on the use of mHealth for the promotion of PA42. A qualitative descriptive approach was chosen for its ability to offer broad and rich information, as well as straight descriptions of participants’ attitudes toward the development of a potential mHealth-based intervention43,44. This approach is noted for its usefulness in gaining preliminary insight into a topic and in collecting the first-hand experiences of patients and HCPs43. The conduct and reporting of this study will be in accordance with the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist for focus groups to ensure rigor, comprehensiveness and credibility45.

Research team roles and prior experience

All focus groups will be moderated, transcribed and analysed by D.C., an occupational therapist and PhD candidate. D.C. has completed training in qualitative research which focused on developing the skills of early-career researchers as part of his graduate studies. It included a focus on developing reflexive skills, strategies for improving credibility during analysis, as well as writing. D.C. also has experience of appraising and synthesising qualitative research40. K.R. is a senior lecturer in occupational therapy and an experienced qualitative researcher. K.R. will provide critical feedback throughout the analysis and dissemination stages. S.H. is a lecturer in physiotherapy and an experienced quantitative researcher. S.H., as the principal investigator, has led on the conceptualisation of this research and will contribute to the analysis and dissemination stages. J.F. is an experienced quantitative researcher and health economist with experience in randomised controlled trials of health interventions and programmes for stroke survivors. He has played a large role in planning the study and will also play a role in the final stages of analysis and writing. J.W. is an experienced health psychologist with extensive experience in mobile technology and health behaviour change. J.W. has contributed to the development of the topic guides and will contribute to the analysis, particularly with regards health behaviour change.

Recruitment and participants

Community-dwelling stroke survivors and HCPs will be recruited purposively. Previous research suggests that an estimated 80% of themes are identifiable within three to four focus groups46 and that the modal recommendation for number of individuals participating in a focus group is eight47. However, recruitment will continue until data saturation has been reached, as indicated by redundancy in the data and no new themes being generated48.

Stroke survivors will be recruited from an early supported discharge service for acute stroke patients associated with a regional hospital in the Mid-West of Ireland and local stroke support groups in the Mid-West and Dublin regions of Ireland. Stroke survivors living in the community and able to voluntarily participate will be sought. However, those with severe impairment following stroke will be excluded as it may preclude an individual’s ability to use mHealth apps32,49 and the development of a mHealth intervention for those with more severe impairment is beyond the scope of the current study. Individuals with minimal cognitive and communication impairments are sought to ensure ability to engage in focus group discussions.

HCPs will be recruited through the same acute hospital setting as stroke survivors, as well as two professional bodies (the Association of Occupational Therapists of Ireland and the Irish Society of Chartered Physiotherapists), and Twitter. Representatives from medical, nursing, and the allied health professions will be eligible to attend the focus groups.

All participants must be willing and able to provide informed consent. There is no connection between researchers and participants in either stakeholder group.

Data collection

Focus groups are a popular method of data collection in health research50 and have previously been used to explore lifestyle beliefs and behaviours51 as well as the adoption of technology52 by stroke survivors. They will be used to capitalise on the shared experiences53 within the two stakeholder groups. A semi-structured topic guide comprised of open-ended questions is typical in qualitative descriptive studies43 and will support the researcher to remain flexible by adapting questions and expanding on ideas42,47. This method allows participants to build on one another’s comments by developing, undermining and qualifying their statements and generating rich data in the process42. Importantly, focus groups do not discriminate against individuals who have difficulty reading or writing and can encourage contributions from those who feel they might have nothing to say or those intimidated by one-to-one interviews53. The power differential between HCPs and patients has been explored previously54 and, with a view to minimising the effect of this, focus groups with stroke survivors will be conducted separately from those with HCPs to facilitate candid discussion. Each focus group is expected to last one hour and, in instances where scheduling difficulties or non-attendance occurs, one-to-one interviews will be completed using the same topic guide.

Data will be stored in accordance with the University of Limerick’s Data Protection Policy. Participants will be assigned a unique participant number as each focus group is transcribed. A separate, password-protected Excel file will hold participants’ details and their unique participant number on a password protected laptop. Audio files will be deleted after transcription and the research team will only have access to anonymised transcripts. These transcripts will be stored on a password-protected laptop. Transcripts will not be offered to participants. Consent forms will be stored on-site at the School of Allied Health in a locked cabinet. Data will be retained for seven years. After this time, all electronic copies of data will be deleted and all hard copies will be shredded.

Topic guides

Topic guides were developed by reviewing relevant qualitative literature and are available as Extended data55. As noted above, a systematic review was conducted to explore the experiences of adults using mHealth for the promotion of PA40. Although no studies exploring the experiences of stroke survivors were identified, it did note the central role of motivation. For this reason, behaviour change theory was considered important in developing the topic guides. Guidelines from the National Institute for Health and Care Excellence (NICE) recommend that interventions targeting behaviour change should incorporate relevant theory and highlight the Capability, Opportunity and Motivation (COM-B) Model56 developed by Michie and colleagues as part of their Behaviour Change Wheel framework57. This model proposes that behaviours arise from an interaction between capability, opportunity, and motivation, and that a successful behaviour change intervention must address deficits related to one or more of those conditions56,57. The COM-B model has previously been applied to guide an exercise intervention in adult stroke survivors58 and was selected to inform the topic guides for both stakeholder groups. Qualitative studies exploring patient and HCP attitudes towards digital health interventions for blood pressure management59,60 and barriers and facilitators to PA in stroke survivors6163 also contributed to the included questions.

The topic guide for stroke survivors will explore their current level of PA in the context of the COM-B model64 in preparation for asking them to consider using mHealth to promote PA. This topic guide will incorporate a “think aloud” component where participants interact with a mHealth app while saying out loud their thoughts41. This strategy was selected to facilitate discussion by making the idea of a mHealth intervention less abstract. Think-aloud strategies have been recommended for engaging end-users in mHealth app development65 and have been used effectively in exploring patients’ attitudes towards digital health interventions59,66,67. The app selected for stroke survivors to interact with is “Active 10” by Public Health England68. It encourages brisk walking and was selected because it is currently being promoted by general practitioners6972 and public health nurses73,74 and because it contains features commonly reported in apps aimed at promoting PA3537.

The topic guide for HCPs will explore their perspectives on barriers and facilitators to PA in stroke survivors6163 in the context of the COM-B model64. Questions specific to HCPs were informed in part by a systematic review exploring barriers and facilitators to mHealth adoption by health professionals75. This review identified 179 elements related to barriers and facilitators and separated these into four domains. These domains included mHealth characteristics (e.g. perceived usefulness and ease of use), individual factors (e.g. familiarity with mHealth and technology), external factors related to the human environment (e.g. patients’ attitudes to mHealth), and external factors related to the organisational environment (e.g. workload and human resources).

Analysis

Focus groups will be audio-recorded, transcribed and exported to NVivo (Version 12, QSR International) for analysis by D.C. Thematic analysis was selected for its theoretical flexibility, as well as its ability to generate findings which are accessible to the educated general population, supporting dissemination to HCPs and stroke survivors alike76. An iterative approach to analysis will be taken where data collection and analysis occur concurrently to inform one another77. The current study will rely on an essentialist/realist paradigm, which assumes a unidirectional relationship between meaning and experience and language, and supports the theorising of participants’ experiences, meanings and realities in a straightforward way76. Data will be analysed inductively with codes based on the content of data rather than relying on existing concepts or frameworks76. Themes will be identified on a semantic level with a focus on the explicit content of the transcripts76. Standard approaches to ensuring trustworthiness will be employed, including engaging in reflexivity through the self-disclosure of biases and assumptions which might influence the interpretation of data, documentation of decisions made throughout the process in the form of an audit trail, and negative case analysis with a view to scrutinising emerging themes against any discrediting data78,79.

The thematic analysis will be carried out in accordance with the six steps outlined by Braun and Clarke76,80. The first step will involve familiarisation with the data. This will be achieved initially through transcription and again through reading and rereading the data. Initial thoughts will be recorded during this process to inform the next step. The second step will involve generating initial codes systematically across the data set76. All segments of data potentially relevant to the research question will be coded. In the third step, searching for themes will commence. This will involve identifying overlapping codes80, with each theme representing a pattern of responses in the data76. Step four will involve reviewing potential themes. This will require questioning the boundaries of and judging whether there is sufficient data to support each theme. In step five, clear definitions and names will be established for each theme. The sixth step involves producing the final report. This will be achieved through the preparation of a manuscript which weaves together the themes in a logical and meaningful manner, generating a compelling story of the data drawn from the analysis76. Themes will be supported by anonymised quotations from participants.

Ethics approval and consent to participate

Ethical approval has been granted by the HSE Mid-Western Regional Hospital Research Ethics Committee [REC Ref 102/17] and the Faculty of Education and Health Sciences Research Ethics Committee at the University of Limerick [2019_04_04_EHS]. At the start of each focus group, D.C. will review the participant information leaflet with participants. It will be made clear in writing and orally that the current study forms a component of D.C.’s doctoral studies, that participation is voluntary in nature, that the right to withdraw at any time is guaranteed, that data will be stored securely and that participants will not be identifiable in any output generated. Each focus group will only commence when informed consent from all participants is received.

Dissemination

Following the analysis, the findings will be submitted for publication in peer-reviewed journals. They will also be presented at relevant international academic conferences in the areas of mHealth or stroke. The findings will be presented locally to attendees of groups which support stroke survivors.

Conclusion

The current study is being conducted with a view to developing the evidence base for a mHealth intervention to promote PA in stroke survivors. To our knowledge, no prior study has attempted to explore the perspectives of stakeholders on this topic. The project is guided by the development stage of the MRC framework for complex interventions39. It follows on from a recently completed systematic review and meta-synthesis exploring the experiences of adults using mHealth for the promotion of PA40 and recommendations that digital interventions incorporate qualitative research and end-users’ perspectives25,41.

Data availability

Underlying data

No underlying data are associated with this article.

Extended data

Open Science Framework: Exploring the perspectives of stroke survivors and healthcare professionals on the use of mobile health to promote physical activity. https://doi.org/10.17605/OSF.IO/W4JQZ55.

This project contains the stakeholder topic guides.

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Carter DD, Robinson K, Forbes J et al. Exploring the perspectives of stroke survivors and healthcare professionals on the use of mobile health to promote physical activity: A qualitative study protocol [version 1; peer review: 2 approved]. HRB Open Res 2019, 2:9 (https://doi.org/10.12688/hrbopenres.12910.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
VERSION 1
PUBLISHED 06 Jun 2019
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Reviewer Report 09 Aug 2019
Taryn M. Jones, Department of Health Professions, Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia 
Approved
VIEWS 34
Overall this protocol report is clear and concise, displaying good justification for the research to be conducted, and a strong understanding of the methodological process by which the study aims can be met. I suggest a few amendments which could ... Continue reading
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HOW TO CITE THIS REPORT
Jones TM. Reviewer Report For: Exploring the perspectives of stroke survivors and healthcare professionals on the use of mobile health to promote physical activity: A qualitative study protocol [version 1; peer review: 2 approved]. HRB Open Res 2019, 2:9 (https://doi.org/10.21956/hrbopenres.13986.r26727)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Reviewer Report 21 Jun 2019
Mary E. Walsh, HRB Centre for Primary Care Research, Royal College of Surgeons in Ireland (RCSI), Dublin, Ireland;  School of Physiotherapy, Royal College of Surgeons in Ireland (RCSI), Dublin, Ireland 
Approved
VIEWS 63
This qualitative protocol is very well written, demonstrates good scientific practice to ensure validity, and is transparent in line with COREQ guidelines.
I would recommend some minor amendments to improve clarity:

Abstract:
The Abstract places ... Continue reading
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CITE
HOW TO CITE THIS REPORT
Walsh ME. Reviewer Report For: Exploring the perspectives of stroke survivors and healthcare professionals on the use of mobile health to promote physical activity: A qualitative study protocol [version 1; peer review: 2 approved]. HRB Open Res 2019, 2:9 (https://doi.org/10.21956/hrbopenres.13986.r26621)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

Version 1
VERSION 1 PUBLISHED 06 Jun 2019
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Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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