Exploring the factors for the implementation of digital health tools
| ISRCTN | ISRCTN16805986 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16805986 |
| IRAS number | 288651 |
| Secondary identifying numbers | CPMS 48004, IRAS 288651 |
- Submission date
- 23/03/2021
- Registration date
- 25/03/2021
- Last edited
- 06/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Digital tools, such as websites, mobile applications, and wearable devices, offer great potential to support people with long-term conditions to be physically active. The Covid-19 pandemic has also increased the awareness and use of these tools. Previous research has demonstrated that digital tools can be effective in supporting people to start being more active. There is also an increasing amount of research looking at the potential of these technologies to help people to stay active in the longer-term. However, the effectiveness and uptake of digital tools relies on more than the technology itself. It is important to consider the needs of those who will use it and understand how digital tools fit into existing healthcare structures and NHS pathways. This project is therefore aiming to understand the factors that influence the successful uptake of digital tools into healthcare practice, at a policy level, for service commissioners and for GPs and specialist clinicians.
The study aims to explore the barriers, facilitators, needs, and preferences that influence the implementation of a digital health intervention for self-management to maintain physical activity in people with a long-term condition, within current UK NHS care pathways. Additionally, the study will identify how policy and standards for implementation of digital health interventions converge and/or diverge with commissioning and practice-level factors
Who can participate?
Commissioners, GPs, and long-term conditions specialist clinicians in Wessex
What does the study involve?
Each participant will take part one semi-structured interview. The study will also review existing policy documents so that comparisons can be made between different multi-level factors.
What are the possible benefits and risks of participating?
Although there are no specific benefits to taking part, the information captured through the interviews will ultimately help to support the future development of successful digital tools into practice. There are unlikely to be any risks associated with participating in this research.
Where is the study run from?
University of Southampton (UK)
When is the study starting and how long do you expect it to run for?
From September 2020 to July 2021
Who is funding the study?
NIHR ARC Wessex (UK)
Who is the main contact?
Dr Paul Clarkson, P.D.Clarkson@soton.ac.uk
Contact information
Scientific
School of Health Sciences
University of Southampton
University Road
Southampton
SO171BJ
United Kingdom
 ORCID ID |
0000-0001-5955-5711 |
|---|---|
| Phone | +44 (0)2380597909 |
| p.d.clarkson@soton.ac.uk |
Study information
| Study design | Observational interview study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Internet/virtual |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Exploring the factors that facilitate and hinder the implementation of digital tools for self-management of long-term conditions within existing healthcare structures and pathways |
| Study objectives | 1. To explore the needs and preferences of GPs, commissioners, and long-term conditions specialist clinicians in relation to using and recommending digital health interventions and the perceived contextual factors facilitating and hindering the implementation of a digital self-management tool to support self-management to maintain for people with a long-term conditions 2. To identify barriers, facilitators and needs of stakeholders to support the development, scale-up and implementation of a digital behaviour change intervention for maintaining physical activity |
| Ethics approval(s) | Approved 11/12/2020, the University of Southampton Ethics and Research Governance Online (Research Integrity and Governance Team, Building 37, University Road, Southampton, SO17 1BJ; no telephone contact provided; ERGOii@soton.ac.uk), ref: 60495.A1 |
| Health condition(s) or problem(s) studied | General practitioners, commissioners, and long-term conditions specialist clinicians |
| Intervention | The study will involve semi-structured interviews exploring the factors that facilitate and hinder the implementation of digital tools for self-management of long-term conditions within existing healthcare structures and pathways. Participants will be recruited via email invitation from the researcher (commissioners) and email invitation from the clinical research network. One interview will be conducted with each participant using video conferencing software or face-to-face interview, if appropriate. |
| Intervention type | Other |
| Primary outcome measure | Needs and preferences of GPs, commissioners, and long-term conditions specialist clinicians in relation to using and recommending digital health interventions and the perceived contextual factors facilitating and hindering the implementation of a digital self-management tool to support self-management to maintain for people with a long-term condition measured using semi-structured interviews at a single time point |
| Secondary outcome measures | Barriers, facilitators and needs of stakeholders to support the development, scale-up and implementation of a digital behaviour change intervention for maintaining physical activity measured using semi-structured interviews at a single time point |
| Overall study start date | 01/09/2020 |
| Completion date | 31/07/2021 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10 |
| Key inclusion criteria | 1. General Practitioners, Service commissioners, Long-term condition specialist clinicians in Wessex 2. Specialist clinicians supporting people with one or more of the following conditions: 2.1. Cardiovascular disease, including Atrial Fibrillation, Hypertension, Heart failure, Peripheral arterial disease, secondary prevention of coronary heart disease 2.2. Myocardial infarction: secondary prevention 2.3. Stroke/TIA 2.4. Asthma 2.5. COPD 2.6. Chronic kidney disease 2.7. Diabetes mellitus 2.8. Dementia 2.9. Epilepsy 2.10. Mental Health 2.11. Depression 2.12. Osteoporosis 2.13. Rheumatoid arthritis 2.14. Osteoarthritis 2.15. Obesity |
| Key exclusion criteria | 1. Specialist clinicians for conditions other than those listed above 2. GPs, Commissioners, Clinicians outside of the Wessex region |
| Date of first enrolment | 12/04/2021 |
| Date of final enrolment | 30/06/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Tollbar Way
Hedge End
Southampton
SO30 2UN
United Kingdom
Sponsor information
University/education
University Road
Southampton
SO17 1BJ
England
United Kingdom
| Phone | +44 (0)23 8059 5058 |
|---|---|
| RGOInfo@soton.ac.uk | |
| Website | http://www.southampton.ac.uk/ |
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 30/09/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | This study is planned to be published in a high impact journal, such as Implementation Science, BMJ Open, or BMC Health Services Research. The study findings will also support future work on the development and implementation of a digital intervention. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository (University of Southampton Institutional Research Repository (https://eprints.soton.ac.uk). Consent will be obtained from participants and the data will be available to the research team for analysis using content analysis and synthesis using the Consolidated Framework for Implementation Research, and pseudonymised for publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v2.1 | 14/09/2020 | 06/04/2021 | No | No |
Additional files
- ISRCTN16805986_PROTOCOL_v2.1_14Sept2020.pdf
- Uploaded 06/04/2021
Editorial Notes
06/04/2021: Uploaded protocol Version 2.1, 14 September 2020 (not peer reviewed).
24/03/2021: Trial’s existence confirmed by HRA and Health and Care Research Wales.
