Promoting independence in dementia (PRIDE): a feasibility randomised controlled trial of the PRIDE intervention for people with mild dementia

2018 ◽  
Author(s):  
Aisha Shafayat
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Mild Dementia ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

scholarly journals Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Aisha Shafayat ◽  
Emese Csipke ◽  
Lucy Bradshaw ◽  
Georgina Charlesworth ◽  
Florence Day ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Rating Scale ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Mild Dementia ◽  
Link Type ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial. Trial registration ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

scholarly journals Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial

2019 ◽  
Author(s):  
Aisha Shafayat ◽  
Emese Csipke ◽  
Lucy Bradshaw ◽  
Georgina Charlesworth ◽  
Florence Day ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Feasibility Trial ◽  
Self Management ◽  
Mild Dementia ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/Design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at three and six month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at three to six months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so will provide data to inform the design and conduct of a future trial. Trial Registration and protocol version ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019 Keywords Dementia, self-management, feasibility trial

scholarly journals Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial

2019 ◽  
Author(s):  
Aisha Shafayat ◽  
Emese Csipke ◽  
Lucy Bradshaw ◽  
Georgina Charlesworth ◽  
Florence Day ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Feasibility Trial ◽  
Self Management ◽  
Mild Dementia ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/Design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at three and six month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at three to six months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so will provide data to inform the design and conduct of a future trial. Trial Registration and protocol version ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019 Keywords Dementia, self-management, feasibility trial

scholarly journals Bathing adaptations in the homes of older adults (BATH-OUT): results of a feasibility randomised controlled trial (RCT)

2018 ◽  
Vol 18 (1) ◽  
Author(s):  
Phillip J. Whitehead ◽  
Miriam R. Golding-Day ◽  
Stuart Belshaw ◽  
Tony Dawson ◽  
Marilyn James ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

scholarly journals Dexamethasone versus prednisone for children receiving asthma treatment in the paediatric inpatient population: protocol for a feasibility randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e025630 ◽  
Author(s):  
Catherine M Pound ◽  
Jaime McDonald ◽  
Ken Tang ◽  
Gillian Seidman ◽  
Radha Jetty ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Clinical Outcome ◽  
Controlled Trial ◽  
Asthma Treatment ◽  
Treatment Regimens ◽  
Asthma Exacerbations ◽  
Feasibility Randomised Controlled Trial ◽  
Short Course ◽  
Inpatient Population ◽  
Randomised Controlled

IntroductionAsthma exacerbations are a leading cause of paediatric hospitalisations. Corticosteroids are key in the treatment of asthma exacerbations. Most current corticosteroids treatment regimens for children admitted with asthma exacerbation consist of a 5-day course of prednisone or prednisolone. However, these medications are associated with poor taste and significant vomiting, resulting in poor compliance with the treatment course. While some centres already use a short course of dexamethasone for treating children hospitalised with asthma, there is no evidence to support this practice in the inpatient population.Methods and analysisThis single-site, pragmatic, feasibility randomised controlled trial will determine the feasibility of a non-inferiority trial, comparing two treatment regimens for children admitted to the hospital and receiving asthma treatment. Children 18 months to 17 years presenting to a Canadian tertiary care centre will be randomised to receive either a short course of dexamethasone or a longer course of prednisone/prednisolone once admitted to the inpatient units. The primary clinical outcome for this feasibility study will be readmission to hospital or repeat emergency department visits, or unplanned visits to primary healthcare providers for asthma symptoms within 4 weeks of hospital discharge. Feasibility outcomes will include recruitment and allocation success, compliance with study procedures, retention rate, and safety and tolerability of study medications. We plan on recruiting 51 children, and between-group comparisons of the clinical outcome will be conducted to gain insights on probable effect sizes.Ethics and disseminationResearch Ethics Board approval has been obtained for this study. The results of this study will inform a multisite trial comparing prednisone/prednisolone to dexamethasone in inpatient asthma treatment, which will have the potential to improve the delivery of asthma care, by improving compliance with a mainstay of treatment. Results will be disseminated through peer-reviewed publications, organisations and meetings.Trial registration numberNCT03133897; Pre-results.

scholarly journals A feasibility randomised controlled trial of the DECIDE intervention: Dementia carers making informed decisions

BJPsych Open ◽  
2017 ◽  
Vol 3 (1) ◽  
pp. 12-14 ◽  
Author(s):  
Kathryn Lord ◽  
Gill Livingston ◽  
Claudia Cooper
Keyword(s):  
Randomised Controlled Trial ◽  
Family Conflict ◽  
Decision Aid ◽  
Controlled Trial ◽  
Intervention Group ◽  
Decisional Conflict ◽  
Manual Aiming ◽  
Family Carers ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

SummaryFamily carers report high levels of decisional conflict when deciding whether their relative with dementia can continue to be cared for in their own home. We tested, in a feasibility randomised controlled trial, the first decision aid (the DECIDE manual) aiming to reduce such conflict. Twenty family carers received the DECIDE intervention, and 21 received usual treatment. The intervention group had reduced decisional conflict compared with controls (mean difference −11.96, 95% confidence interval −20.10 to −3.83, P=0.005). All carers receiving the intervention completed and valued it, despite some still reporting difficulties with family conflict and problems negotiating services.

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