scholarly journals IDEA intervention to prevent depressive symptoms and promote well-being in early-stage dementia: protocol for a randomised controlled feasibility study

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e021074 ◽  
Author(s):  
Remco Tuijt ◽  
Gill Livingston ◽  
Rebecca L Gould ◽  
Rebecca Jones ◽  
Elisabet Sole Verdaguer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Depressive Symptoms ◽  
Early Stage ◽  
Controlled Trial ◽  
Well Being ◽  
Psychological Interventions ◽  
Mild Dementia ◽  
People With Dementia ◽  
Randomised Controlled

ObjectiveDepressive symptoms are common among people with dementia, impacting quality of life and cognitive and functional decline. Currently, little is known about the acceptability and feasibility of psychological interventions for people with mild dementia, with recent reviews identifying the need for further evidence. Developing and evaluating psychological interventions to prevent and treat these symptoms is, therefore, an important clinical and research priority. This protocol describes a study testing the acceptability and feasibility of a manual-based behavioural activation (BA) intervention for preventing and treating depressive symptoms in people with mild dementia. The aim of this study is to explore the feasibility of conducting a pragmatic multicentre randomised controlled trial of clinical effectiveness of an eight-session intervention. The Intervention to prevent Depressive symptoms and promote well-being in EArly-stage dementia (IDEA) programme supports people with dementia and their family carers in identifying and scheduling enjoyable and meaningful activities.Methods and analysisSixty people who have received a diagnosis of dementia of any type in the last 6 months will be recruited via memory clinics. Further criteria are a Mini-Mental State Examination score of ≥20, and a family carer who can assist with the intervention. Consenting participants will be randomised in a ratio of 2:1 to BA or to treatment as usual. Analyses will estimate parameters such as rates of recruitment, retention and number of sessions completed. Questionnaires measuring depressive symptoms and quality of life for both the person with dementia and their carer will be completed at baseline, 3 and 6 months. Qualitative interviews will explore acceptability of the intervention, study procedures and experiences of the sessions.Ethics and disseminationThis study received a favourable ethical opinion from the London Camberwell St Giles Research Ethics Committee (16/LO/0540). We will disseminate findings at key conferences, the Alzheimer’s Society and University College London websites and local stakeholder events.Trial registration numberISRCTN75503960; Pre-results.

scholarly journals Estimating the minimum important difference in the DEMQOL instrument in people with dementia

2021 ◽  
Author(s):  
Ellen C. Lee ◽  
Jessica Wright ◽  
Stephen J. Walters ◽  
Cindy L. Cooper ◽  
Gail A. Mountain
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Minimum Important Difference ◽  
Absolute Change ◽  
People With Dementia ◽  
Related Quality ◽  
Registration Number ◽  
Clinically Significant ◽  
Randomised Controlled

Abstract Purpose The Dementia-Related Quality of Life (DEMQOL) measure and the DEMQOL-Utility Score (DEMQOL-U) are validated tools for measuring quality of life (QOL) in people with dementia. What score changes translate to a clinically significant impact on patients’ lives was unknown. This study establishes the minimal important differences (MID) for these two instruments. Methods Anchor-based and distribution-based methods were used to estimate the MID scores from patients enrolled in a randomised controlled trial. For the anchor-based method, the global QOL (Q29) item from the DEMQOL was chosen as the anchor for DEMQOL and both Q29 and EQ-5D for DEMQOL-U. A one category difference in Q29, and a 0.07 point difference in EQ-5D score, were used to classify improvement and deterioration, and the MID scores were calculated for each category. These results were compared with scores obtained by the distribution-based methods. Results A total of 490 people with dementia had baseline DEMQOL data, of these 386 had 8-month data, and 344 had 12-month DEMQOL data. The absolute change in DEMQOL for a combined 1-point increase or decrease in the Q29 anchor was 5.2 at 8 months and 6.0 at 12 months. For the DEMQOL-U, the average absolute change at 8 and 12 months was 0.032 and 0.046 for the Q29 anchor and 0.020 and 0.024 for EQ-5D anchor. Conclusion We present MID scores for the DEMQOL and DEMQOL-U instruments obtained from a large cohort of patients with dementia. An anchored-based estimate of the MID for the DEMQOL is around 5 to 6 points; and 0.02 to 0.05 points for the DEMQOL-U. The results of this study can guide clinicians and researchers in the interpretation of these instruments comparisons between groups or within groups of people with dementia. Trial Registration Number and date of registration: ISRCTN17993825 on 11th October 2016.

scholarly journals Pilot Randomised Evaluation of Singing in Dementia (PRESIDE): protocol for a two-arm, parallel-group randomised controlled feasibility study with waiting-list control

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Becky Dowson ◽  
Justine Schneider ◽  
Boliang Guo ◽  
Philip M. Bath ◽  
Orii McDermott ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Waiting List ◽  
Community Group ◽  
People With Dementia ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Person With Dementia

Abstract Background As the number of people living with dementia grows, so does the need to provide them with adequate psychosocial support. Many people with dementia live at home with family carers, who also require social and emotional support to cope with their role. Community group singing has received attention for its potential to support people with dementia and their carers. It is postulated that singing can improve cognitive function, strengthen the bonds between care partners and help to establish social support networks. However, there is a lack of rigorous evidence of singing’s benefits for this population. This study aims to test the feasibility of a randomised controlled trial of community singing in dementia, to pave the way for a larger, conclusive study. Methods The PRESIDE study is designed as a two-arm, parallel-group randomised trial with a waiting list control. Dyads consisting of a person with dementia (n = 80) and their carer (n = 80) will be recruited. Each dyad will be randomised either to attend 10 weeks of community group singing sessions straight away or to wait for 3 months before attending the sessions. The singing sessions will be led by experienced professional musicians and will last about 90 min, including time for socialising. The primary outcome of this study is the attainment of feasibility criteria around recruitment, retention and the acceptability of the waiting list control. Secondary outcomes include the quality of life, mood, cognition, and musical engagement of the person with dementia, and quality of life, mood, and experiences/challenges of the carer. These data will be collected during home visits at baseline, and 3 and 6 months post-baseline. Discussion Despite growing public interest in the positive effects of singing, and encouraging findings from qualitative and non-randomised quantitative studies, there is a lack of rigorous evidence. This is the first randomised controlled trial of community group singing for people with dementia in Europe, to our knowledge. If the results favour a full trial, conclusively demonstrating the effectiveness of group singing could positively affect the opportunities available to community-dwelling people with dementia and their carers. Trial registration Unique identification number in ISRCTN registry: ISRCTN10201482. Date registered: 12 May 2020

scholarly journals Pilot Randomised Evaluation of Singing in Dementia (PRESIDE): protocol for a two-arm, parallel group randomised controlled feasibility study with waiting-list control

2020 ◽  
Author(s):  
Becky Dowson ◽  
Justine Schneider ◽  
Boliang Guo ◽  
Philip M Bath ◽  
Orii McDermott ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Waiting List ◽  
Community Group ◽  
People With Dementia ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Person With Dementia

Abstract BackgroundAs the number of people living with dementia grows, so does the need to provide them with adequate psychosocial support. Many people with dementia live at home with family carers, who also require social and emotional support to cope with their role. Community group singing has received attention for its potential to support people with dementia and their carers. It is postulated that singing can improve cognitive function, strengthen the bonds between care partners, and help to establish social support networks. However, there is a lack of rigorous evidence of singing’s benefits for this population. This study aims to test the feasibility of a randomised controlled trial of community singing in dementia, to pave the way for a larger, conclusive study.MethodsThe PRESIDE study is designed as a two-arm, parallel group randomised trial with a waiting list control. Dyads consisting of a person with dementia (n=80) and their carer (n=80) will be recruited. Each dyad will be randomised either to attend 10 weeks of community group singing sessions straight away, or to wait for three months before attending the sessions. The singing sessions will be led by experienced professional musicians and will last about 90 minutes, including time for socialising. The primary outcome of this study is the attainment of feasibility criteria around recruitment, retention and the acceptability of the waiting list control. Secondary outcomes include the quality of life, mood, cognition, and musical engagement of the person with dementia, and quality of life, mood, and experiences/challenges of the carer. These data will be collected during home visits at baseline, and three and six months post-baseline. DiscussionDespite growing public interest in the positive effects of singing, and encouraging findings from qualitative and non-randomised quantitative studies, there is a lack of rigorous evidence. This is the first randomised controlled trial of community group singing for people with dementia in Europe, to our knowledge. If the results favour a full trial, conclusively demonstrating the effectiveness of group singing could positively affect the opportunities available to community-dwelling people with dementia and their carers.Trial RegistrationUnique identification number in ISRCTN registry: ISRCTN10201482 https://www.isrctn.com/ISRCTN10201482. Date registered: 12/05/2020

scholarly journals Virtual reality for relatives of ICU patients to improve psychological sequelae: study protocol for a multicentre, randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e049704
Author(s):  
Johan H Vlake ◽  
Jasper van Bommel ◽  
Evert-Jan Wils ◽  
Tim Korevaar ◽  
Merel E Hellemons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Virtual Reality ◽  
Intensive Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Icu Patients ◽  
Randomised Controlled

IntroductionIntensive care unit (ICU) admission of a relative might lead to psychological distress and complicated grief (post-intensive care syndrome–family; PICS-F). Evidence suggests that increased distress during ICU stay increases risk of PICS-F, resulting in difficulty returning to their normal lives after the ICU experience. Effective interventions to improve PICS-F are currently lacking. In the present trial, we hypothesised that information provision using ICU-specific Virtual Reality for Family members/relatives (ICU-VR-F) may improve understanding of the ICU and subsequently improve psychological well-being and quality of life in relatives of patients admitted to the ICU.Methods and analysisThis multicentre, clustered randomised controlled trial will be conducted from January to December 2021 in the mixed medical-surgical ICUs of four hospitals in Rotterdam, the Netherlands. We aim to include adult relatives of 160 ICU patients with an expected ICU length of stay over 72 hours. Participants will be randomised clustered per patient in a 1:1 ratio to either the intervention or control group. Participants allocated to the intervention group will receive ICU-VR-F, an information video that can be watched in VR, while the control group will receive usual care. Initiation of ICU-VR-F will be during their hospital visit unless participants cannot visit the hospital due to COVID-19 regulations, then VR can be watched digitally at home. The primary objective is to study the effect of ICU-VR-F on psychological well-being and quality of life up to 6 months after the patients’ ICU discharge. The secondary outcome is the degree of understanding of ICU treatment and ICU modalities.Ethics and disseminationThe Medical Ethics Committee of the Erasmus Medical Centre, Rotterdam, the Netherlands, approved the study and local approval was obtained from each participating centre (NL73670.078.20). Our findings will be disseminated by presentation of the results at (inter)national conferences and publication in scientific, peer-reviewed journals.Trial registration numberNetherlands Trial Register (TrialRegister.nl, NL9220).

Identity, mood, and quality of life in people with early-stage dementia

2012 ◽  
Vol 24 (8) ◽  
pp. 1306-1315 ◽  
Author(s):  
Lisa S. Caddell ◽  
Linda Clare
Keyword(s):  
Quality Of Life ◽  
Positive Impact ◽  
Early Stage ◽  
Well Being ◽  
Cross Sectional ◽  
Early Stages ◽  
The People ◽  
People With Dementia ◽  
Relationship Of

ABSTRACTBackground: There is little empirical research regarding the relationships between identity and well-being in people with dementia. The aim of the study was to explore the relationship of identity with mood and quality of life (QoL) in the people in the early stages of dementia.Method: This was a cross-sectional questionnaire-based study. Fifty people in the early stages of dementia completed measures pertaining to different aspects of identity, mood, and QoL. Multiple regression analyses were carried out to determine whether it was possible to predict any of the variance in mood and QoL from aspects of identity.Results: It was possible to predict 12.8% of the variance in anxiety, 23.4% of the variance in depression, and 25.1% of the variance in QoL from different aspects of identity. Predictors varied for each dependent variable.Conclusions: Aspects of identity predict a modest proportion of the variance in anxiety, depression, and QoL. This suggests that supporting identity in people with dementia who are experiencing difficulties in this regard might have a positive impact on mood and QoL. However, the majority of the variance in mood and QoL must be accounted for by other variables.

scholarly journals Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024862 ◽  
Author(s):  
Adele Krusche ◽  
Katherine Bradbury ◽  
Teresa Corbett ◽  
Jane Barnett ◽  
Beth Stuart ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Well Being ◽  
Improve Quality ◽  
Randomised Controlled ◽  
Human Support

IntroductionLow quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management.Methods and analysisA randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support.Ethics and disseminationThe trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations.Trial registration numberISRCTN96374224; Pre-results.

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