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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

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

Jessica Wright

Alexis Foster

Cindy Cooper

KIRSTY SPRANGE

Stephen Walters

Katherine Berry

Esme Moniz-Cook

Amanda Loban

Tracey Anne Young

Claire Craig

Tom Dening

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

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
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

Kirsty Sprange
Project Member

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.

Journal Article Type Article
Publication Date Sep 13, 2019
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 9
Article Number e029207
APA6 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, https://doi.org/10.1136/bmjopen-2019-029207
DOI https://doi.org/10.1136/bmjopen-2019-029207
Publisher URL https://bmjopen.bmj.com/content/9/9/e029207

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