Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care
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 creat...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2019-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/9/e029207.full |
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| author | Tom Dening Jessica Wright Gail Mountain Kirsty Sprange Cindy Cooper Ellen Lee Stephen Walters Alexis Foster Katherine Berry Esme Moniz-Cook Amanda Loban Tracey Anne Young Claire Craig Julie Beresford-Dent Benjamin John Thompson Emma Young Benjamin David Thomas |
| author_facet | Tom Dening Jessica Wright Gail Mountain Kirsty Sprange Cindy Cooper Ellen Lee Stephen Walters Alexis Foster Katherine Berry Esme Moniz-Cook Amanda Loban Tracey Anne Young Claire Craig Julie Beresford-Dent Benjamin John Thompson Emma Young Benjamin David Thomas |
| author_sort | Tom Dening |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-ce4a4c65be6f4f92be8fbcdb0a0de42e |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-ce4a4c65be6f4f92be8fbcdb0a0de42e2025-08-20T02:27:46ZengBMJ Publishing GroupBMJ Open2044-60552019-09-019910.1136/bmjopen-2019-029207Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual careTom Dening0Jessica Wright1Gail Mountain2Kirsty Sprange3Cindy Cooper4Ellen Lee5Stephen Walters6Alexis Foster7Katherine Berry8Esme Moniz-Cook9Amanda Loban10Tracey Anne Young11Claire Craig12Julie Beresford-Dent13Benjamin John Thompson14Emma Young15Benjamin David Thomas16Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UKClinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UKprofessor of applied dementia studiesNottingham Clinical Trials Unit, University of Nottingham, Nottingham, UKprofessor of health services research and clinical trials1 Sheffield Clinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UK2 School of Health and Related Research, University of Sheffield, Sheffield, UKSheffield centre for Health and Related Research, University of Sheffield, Sheffield, UK4 Division of Psychology and Mental Health, The University of Manchester, Manchester, UK5 University of Hull, Hull, UK1 ScHARR, The University of Sheffield, Sheffield, UK2 School of Health and Related Research, University of Sheffield, Sheffield, UKLab4Living, Sheffield Hallam University, Sheffield, South Yorkshire, UKCentre for Applied Dementia Studies, University of Bradford, Bradford, UK1 Sheffield Clinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UK3Barts Health NHS Trust4 Clinical Trials Research Unit (CTRU), Health Services Research School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UKIntroduction 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.https://bmjopen.bmj.com/content/9/9/e029207.full |
| spellingShingle | Tom Dening Jessica Wright Gail Mountain Kirsty Sprange Cindy Cooper Ellen Lee Stephen Walters Alexis Foster Katherine Berry Esme Moniz-Cook Amanda Loban Tracey Anne Young Claire Craig Julie Beresford-Dent Benjamin John Thompson Emma Young Benjamin David Thomas 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 |
| title | Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care |
| title_full | Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care |
| title_fullStr | Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care |
| title_full_unstemmed | Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care |
| title_short | Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care |
| title_sort | study protocol for a randomised controlled trial assessing the clinical and cost effectiveness of the journeying through dementia jtd intervention compared to usual care |
| url | https://bmjopen.bmj.com/content/9/9/e029207.full |
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