Jessica Wright
Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care
Wright, Jessica; Foster, Alexis; Cooper, Cindy; SPRANGE, KIRSTY; Walters, Stephen; Berry, Katherine; Moniz-Cook, Esme; Loban, Amanda; Anne Young, Tracey; Craig, Claire; Dening, Tom; Lee, Ellen; Beresford-Dent, Julie; John Thompson, Benjamin; Young, Emma; David Thomas, Benjamin; Mountain, Gail
Authors
Alexis Foster
Cindy Cooper
KIRSTY SPRANGE KIRSTY.SPRANGE@NOTTINGHAM.AC.UK
Assistant Professor
Stephen Walters
Katherine Berry
Esme Moniz-Cook
Amanda Loban
Tracey Anne Young
Claire Craig
TOM DENING TOM.DENING@NOTTINGHAM.AC.UK
Clinical Professor in Dementia Research
Ellen Lee
Julie Beresford-Dent
Benjamin John Thompson
Emma Young
Benjamin David Thomas
Gail Mountain
Contributors
Jessica Wright
Project Manager
Alexis Foster
Project Manager
Cindy Cooper
Project Member
KIRSTY SPRANGE KIRSTY.SPRANGE@NOTTINGHAM.AC.UK
Project Member
Stephen Walters
Project Member
Katherine Berry
Project Member
Esme Moniz-Cook
Project Member
Amanda Loban
Project Member
Tracey Anne Young
Project Member
Claire Craig
Project Member
TOM DENING TOM.DENING@NOTTINGHAM.AC.UK
Project Member
Ellen Lee
Project Member
Julie Beresford-Dent
Project Member
Benjamin John Thompson
Project Member
Emma Young
Project Member
Benjamin David Thomas
Project Member
Gail Mountain
Project Leader
Abstract
Introduction: Services are being encouraged to provide postdiagnostic treatment to those with dementia but the availability of evidence-based interventions following diagnosis has not kept pace with increase in demand. To address this need, the Journeying through Dementia (JtD) intervention was created. A randomised controlled trial (RCT), based on a pilot study, is in progress.
Methods and analysis: The RCT is a pragmatic, two-arm, parallel group trial designed to test the clinical and cost-effectiveness of JtD compared with usual care. Recruitment will be through NHS services, third sector organisations and Join Dementia Research. The sample size is 486 randomised (243 to usual care and 243 to the intervention usual care). Participants can choose to ask a friend or relative (supporter) to become involved in the study. The primary outcome measure for participants is Dementia-Related Quality of Life (DEMQOL), collected at baseline and at 8 months’ postrandomisation. Secondary outcome measures will be collected from participants and supporters at those visits. Participants will also be followed up at 12 months’ postrandomisation with a reduced set of measures. A process evaluation will be conducted through qualitative and fidelity substudies. Analyses will compare the two arms of the trial on an intention to treat as allocated basis. The primary analyses will compare the mean DEMQOL scores of the participants at 8 months between the two study arms. A cost-effectiveness analysis will consider the incremental cost per Quality Adjusted Life Years of the intervention compared with usual care. Qualitative and fidelity substudies will be analysed through framework analysis and fidelity assessment tools respectively.
Ethics and dissemination: REC and HRA approval were obtained. A Data Monitoring and Ethics Committee has been constituted. Dissemination will be via publications, conferences and social media. Intervention materials will be made open access.
Trial registration number ISRCTN17993825.
Citation
Wright, J., Foster, A., Cooper, C., SPRANGE, K., Walters, S., Berry, K., …Mountain, G. (2019). Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care. BMJ Open, 9(9), Article e029207. https://doi.org/10.1136/bmjopen-2019-029207
Journal Article Type | Article |
---|---|
Acceptance Date | Aug 9, 2019 |
Online Publication Date | Sep 13, 2019 |
Publication Date | Sep 13, 2019 |
Deposit Date | Sep 16, 2019 |
Publicly Available Date | Sep 16, 2019 |
Journal | BMJ Open |
Electronic ISSN | 2044-6055 |
Publisher | BMJ Publishing Group |
Peer Reviewed | Peer Reviewed |
Volume | 9 |
Issue | 9 |
Article Number | e029207 |
DOI | https://doi.org/10.1136/bmjopen-2019-029207 |
Keywords | General Medicine |
Public URL | https://nottingham-repository.worktribe.com/output/2620676 |
Publisher URL | https://bmjopen.bmj.com/content/9/9/e029207 |
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Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care
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Publisher Licence URL
https://creativecommons.org/licenses/by/4.0/
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