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. 2019 Sep 13;9(9):e029207.
doi: 10.1136/bmjopen-2019-029207.

Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care

Jessica Wright  1 , Alexis Foster  2 , Cindy Cooper  3 , Kirsty Sprange  4 , Stephen Walters  2 , Katherine Berry  5 , Esme Moniz-Cook  6 , Amanda Loban  3 , Tracey Anne Young  2 , Claire Craig  7 , Tom Dening  8 , Ellen Lee  3 , Julie Beresford-Dent  9 , Benjamin John Thompson  3 , Emma Young  3 , Benjamin David Thomas  3 , Gail Mountain  9
Affiliations

Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care

Jessica Wright et al. BMJ Open. .

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.

Keywords: Randomised controlled trial; dementia; post diagnostic support; research protocol; self-management; well-being.

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Conflict of interest statement

Competing interests: SW, TAY, CCo, JW, AF, AL, EL, BJT, BDT, EY as ScHARR has contracts and/or research grants with the Department of Health, NIHR, MRC and NICE. SW, CCo and TY are coapplicants or coinvestigators on NIHR portfolio grants (NIHR Research Design Service for Yorkshire and Humber; HTA, RfPB, PHR; SDO) and grants from the MRC. SW and TY also receive external examining fees from various UK higher education institutes. SW receives book royalties from publishers including John Wiley and Sons Ltd and Blackwell Publishing. BDT is a Consultant for Arch research in the area of dementia.

Figures

Figure 1
Figure 1
Participant flow through the study.
See this image and copyright information in PMC

References

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