scholarly journals AQUEDUCT Intervention for Crisis Team Quality and Effectiveness in Dementia: Protocol for a Feasibility Study (Preprint)

2020 ◽  
Author(s):  
Emma Elizabeth Broome ◽  
Donna Maria Coleston-Shields ◽  
Tom Dening ◽  
Esme Moniz-Cook ◽  
Fiona Poland ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Feasibility Study ◽  
Large Scale ◽  
Best Practice ◽  
Controlled Trial ◽  
Practice Model ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
People With Dementia ◽  
Need To Evaluate

BACKGROUND Specialist community teams often support people with dementia who experience crisis. These teams may vary in composition and models of practice, which presents challenges when evaluating their effectiveness. A best practice model for dementia crisis services could be used by teams to improve the quality and effectiveness of the care they deliver. OBJECTIVE The aim of this study is to examine the feasibility of conducting a large-scale randomized controlled trial comparing the AQUEDUCT (Achieving Quality and Effectiveness in Dementia Using Crisis Teams) Resource Kit intervention to treatment as usual. METHODS This is a multisite feasibility study in preparation for a future randomized controlled trial. Up to 54 people with dementia (and their carers) and 40 practitioners will be recruited from 4 geographically widespread teams managing crisis in dementia. Quantitative outcomes will be recorded at baseline and at discharge. This study will also involve a nested health economic substudy and qualitative research to examine participant experiences of the intervention and acceptability of research procedures. RESULTS Ethical approval for this study was granted in July 2019. Participant recruitment began in September 2019, and as of September 2020, all data collection has been completed. Results of this study will establish the acceptability of the intervention, recruitment rates, and will assess the feasibility and appropriateness of the outcome measures in preparation for a large-scale randomized controlled trial. CONCLUSIONS There is a need to evaluate the effectiveness of crisis intervention teams for older people with dementia. This is the first study to test the feasibility of an evidence-based best practice model for teams managing crisis in dementia. The results of this study will assist in the planning and delivery of a large-scale randomized controlled trial. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/18971

scholarly journals AQUEDUCT Intervention for Crisis Team Quality and Effectiveness in Dementia: Protocol for a Feasibility Study

10.2196/18971 ◽  
2020 ◽  
Vol 9 (10) ◽  
pp. e18971
Author(s):  
Emma Elizabeth Broome ◽  
Donna Maria Coleston-Shields ◽  
Tom Dening ◽  
Esme Moniz-Cook ◽  
Fiona Poland ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Feasibility Study ◽  
Large Scale ◽  
Best Practice ◽  
Controlled Trial ◽  
Practice Model ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
People With Dementia ◽  
Need To Evaluate

Background Specialist community teams often support people with dementia who experience crisis. These teams may vary in composition and models of practice, which presents challenges when evaluating their effectiveness. A best practice model for dementia crisis services could be used by teams to improve the quality and effectiveness of the care they deliver. Objective The aim of this study is to examine the feasibility of conducting a large-scale randomized controlled trial comparing the AQUEDUCT (Achieving Quality and Effectiveness in Dementia Using Crisis Teams) Resource Kit intervention to treatment as usual. Methods This is a multisite feasibility study in preparation for a future randomized controlled trial. Up to 54 people with dementia (and their carers) and 40 practitioners will be recruited from 4 geographically widespread teams managing crisis in dementia. Quantitative outcomes will be recorded at baseline and at discharge. This study will also involve a nested health economic substudy and qualitative research to examine participant experiences of the intervention and acceptability of research procedures. Results Ethical approval for this study was granted in July 2019. Participant recruitment began in September 2019, and as of September 2020, all data collection has been completed. Results of this study will establish the acceptability of the intervention, recruitment rates, and will assess the feasibility and appropriateness of the outcome measures in preparation for a large-scale randomized controlled trial. Conclusions There is a need to evaluate the effectiveness of crisis intervention teams for older people with dementia. This is the first study to test the feasibility of an evidence-based best practice model for teams managing crisis in dementia. The results of this study will assist in the planning and delivery of a large-scale randomized controlled trial. International Registered Report Identifier (IRRID) DERR1-10.2196/18971

scholarly journals Evaluation of FindMyApps: protocol for a randomized controlled trial of the effectiveness and cost-effectiveness of a tablet-based intervention to improve self-management and social participation of community-dwelling people with mild dementia, compared to usual tablet use

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David Peter Neal ◽  
Yvonne J. F. Kerkhof ◽  
Teake P. Ettema ◽  
Majon Muller ◽  
Judith Bosmans ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Social Participation ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Self Management ◽  
Tablet Computer ◽  
Randomized Controlled ◽  
People With Dementia

Abstract Background For the rising number of people living with dementia, cost-effective community-based interventions to support psychosocial care are needed. The FindMyApps intervention has been developed with and for people with dementia and their caregivers, to help them use tablets to facilitate self-management and engagement in meaningful social activities. A feasibility study and exploratory pilot trial evaluating FindMyApps have been carried out. This definitive trial further evaluates the effectiveness of the intervention and, for the first time, the cost-effectiveness. Methods A randomized controlled non-blinded single-center two-arm superiority trial will be conducted. Community-dwelling people with Mild Cognitive Impairment (MCI), or dementia with a Mini Mental-State Examination (MMSE) of > 17 and < 26, or Global Deterioration Scale 3 or 4, with an informal caregiver and access to a wireless internet connection will be included. In total, 150 patient-caregiver dyads will be randomly allocated to receive either usual care (control arm – tablet computer; n = 75 dyads) or usual care and the FindMyApps intervention (experimental arm – tablet computer and FindMyApps; n = 75 dyads). The primary outcomes are: for people with dementia, self-management and social participation; for caregivers, sense of competence. In addition to a main effect analysis, a cost-effectiveness analysis will be performed. In line with MRC guidance for evaluation of complex interventions a process evaluation will also be undertaken. Discussion Results of the trial are expected to be available in 2023 and will be submitted for publication in international peer-reviewed scientific journals, in addition to conference presentations and reporting via the EU Marie Sklodowska-Curie DISTINCT ITN network. By providing evidence for or against the effectiveness and cost-effectiveness of the FindMyApps intervention, the results of the trial will influence national implementation of FindMyApps. We hope that the results of the trial will further stimulate research and development at the intersection of technology and psycho-social care in dementia. We hope to further demonstrate that the randomized controlled trial is a valuable and feasible means of evaluating new digital technologies, to stimulate further high-quality research in this growing field. Trial registration number Netherlands Trial Register: NL8157; registered 15th November 2019.

scholarly journals Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): Study Protocol of a Randomized Controlled Trial

2020 ◽  
Vol 17 (2) ◽  
pp. 634 ◽  
Author(s):  
Mayte Serrat ◽  
Juan P. Sanabria-Mazo ◽  
Elna García-Troiteiro ◽  
Anna Fontcuberta ◽  
Corel Mateo-Canedo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Emotional Regulation ◽  
Controlled Trial ◽  
Fibromyalgia Impact Questionnaire ◽  
Number Needed To Treat ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Activity Therapy ◽  
Ecological Momentary

The study protocol of a prospective and randomized controlled trial for the assessment of the efficacy of nature activity therapy for people with Fibromyalgia (NAT-FM) is described. The primary outcome is the mean change from baseline in the Revised Fibromyalgia Impact Questionnaire (FIQR) score at post-treatment (12 weeks) and at 9 months of follow-up, and secondary outcomes are changes in the positive affect, negative affect, pain, fatigue, self-efficacy, catastrophising, and emotional regulation. A total of 160 patients with fibromyalgia will be divided into two arms: treatment-as-usual (TAU) and NAT-FM+TAU. Pre, during, post, +6, and +9 months assessments will be carried out, as well as an ecological momentary assessment (EMA) of intrasession and intersessions. Results will be subjected to a mixed group (NAT-FM+TAU vs. TAU) × phase (pre, post, +6 months, +9 months) general linear model. EMA intrasession measurements will be subjected to a 2 (pre vs. post) × 5 (type of activity) mixed-effects ANOVA. EMA between-session measurements obtained from both arms of the study will be analysed on both a time-domain and frequency-domain basis. Effect sizes and number needed to treat (NNT) will be computed. A mediation/moderation analysis will be conducted.

scholarly journals The efficacy of iCBT added to treatment as usual for alcohol dependent patients in Primary Care: study protocol for a randomized controlled trial.

2019 ◽  
Author(s):  
Karin Hyland ◽  
Anders Hammarberg ◽  
Erik Hedman-Lagerlöf ◽  
Magnus Johansson ◽  
Sven Andreasson
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Alcohol Dependence ◽  
Controlled Trial ◽  
Alcohol Problems ◽  
Primary Study ◽  
Mixed Effect ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Alcohol Dependent

Abstract Introduction Alcohol dependence is a common disorder with a continuum regarding severity. Most alcohol dependent persons have a moderate level of dependence and live under socially orderly conditions. Treatment seeking in this group is low, mainly due to stigma and because treatment options are seen as unappealing. Alcohol is a relevant topic to discuss in many primary care (PC) consultations and PC is less stigmatizing to visit compared to addiction care units for people with alcohol problems. General practitioners (GP) hesitate to engage in treating alcohol problems due to time constraints and lack of knowledge. Screening and brief interventions are effective for high consumers but there are few studies on dependence. Methods This is a two-group, parallel, randomized controlled trial (RCT). The aim is to study whether an Internet based Cognitive Behavioral Treatment (iCBT) when added to treatment as usual (TAU) is more effective than TAU only for alcohol dependence in PC. 260 adults with alcohol dependence will be included. Participants are randomized to iCBT and TAU or TAU only. The primary study outcome is alcohol consumption in grams per week and heavy drinking days. Secondary outcomes include alcohol related problem severity, number of diagnostic criteria for alcohol dependence, depression and anxiety symptoms, health related quality of life and biochemical markers for high consumption and liver pathology. Data will be analyzed using mixed-effect models. Discussion Internet based interventions are attractive to and have been shown to reach people with alcohol problems. Yet there are no studies investigating the efficacy of internet treatment of alcohol dependence in PC. In this study we hypothesize that iCBT when added to TAU will improve treatment outcome for alcohol dependence in PC, compared to TAU only. If effective, iCBT can be distributed to the public to a low cost for a stakeholder and has the opportunity to reduce both short term and long-term public health costs. Trial registration: ISRCTN69957414. Retrospectively registered 07/06/2018. http://www.isrctn.com/ISRCTN69957414

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