scholarly journals Improving hearing and vision in dementia: protocol for a field trial of a new intervention

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e018744 ◽  
Author(s):  
Jemma Regan ◽  
Piers Dawes ◽  
Annie Pye ◽  
Christopher J Armitage ◽  
Mark Hann ◽  
...  
Keyword(s):  
Feasibility Study ◽  
Field Trial ◽  
Controlled Trial ◽  
Full Scale ◽  
Sensory Function ◽  
Open Label ◽  
Process Measures ◽  
People With Dementia ◽  
Home Based ◽  
Adherence Support

IntroductionQuality of life and other key outcomes may be improved by optimising hearing and vision function in people living with dementia. To date, there is limited research assessing the efficacy of interventions aimed at improving hearing and vision in people with dementia. Here, we outline a protocol to field test a newly developed home-based intervention, designed to optimise sensory functioning in people with dementia in three European sites. The results of this study will inform the design and conduct of a full-scale randomised controlled trial (RCT) in five European sites.Methods and analysisIn this multisite, single arm, open label, feasibility study, participants with dementia (n=24) will be assessed for hearing and vision impairments and be prescribed a hearing aid and/or glasses. Each participant will have a study partner (‘dyads’). A subset of dyads will receive ‘sensory support’ from a ‘sensory support therapist’, comprising home visits over 12 weeks. The therapist will offer the following intervention: adherence support for corrective devices; adaptations to the home environment to facilitate sensory function; communication training; and referral to community-based support services. The primary outcomes will be process measures assessing the feasibility, tolerability and acceptability of: (1) the intervention components; (2) the method of implementation of the intervention and (3) the study procedures, including outcome assessment measures. Quantitative data will be collected at baseline and follow-up. Qualitative data using semistructured interviews will be collected postintervention and weekly, using participant diaries. Finally, we will explore a model of cost-effectiveness to apply in the subsequent full-scale trial. This feasibility study is a necessary step in the development of a complex, individualised, psychosocial intervention. The data gathered will allow logistical and theoretical processes to be refined in preparation for a full-scale RCT.Ethics and disseminationEthical approval was obtained in all three participating countries. Results of the field trial will be submitted for publication in a peer-reviewed journal.

scholarly journals HOMESIDE: home-based family caregiver-delivered music and reading interventions for people living with dementia: protocol of a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e031332 ◽  
Author(s):  
Felicity Anne Baker ◽  
Jodie Bloska ◽  
Sabine Braat ◽  
Anna Bukowska ◽  
Imogen Clark ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Psychological Symptoms ◽  
Controlled Trial ◽  
Well Being ◽  
Resource Utilisation ◽  
Home Setting ◽  
Randomised Study ◽  
People With Dementia ◽  
Home Based ◽  
Randomised Controlled

IntroductionPharmacological interventions to address behavioural and psychological symptoms of dementia (BPSD) can have undesirable side effects, therefore non-pharmacological approaches to managing symptoms may be preferable. Past studies show that music therapy can reduce BPSD, and other studies have explored how formal caregivers use music in their caring roles. However, no randomised study has examined the effects on BPSD of music interventions delivered by informal caregivers (CGs) in the home setting. Our project aims to address the need for improved informal care by training cohabiting family CGs to implement music interventions that target BPSD, and the quality of life (QoL) and well-being of people with dementia (PwD) and CGs.Methods and analysisA large international three-arm parallel-group randomised controlled trial will recruit a sample of 495 dyads from Australia, Germany, UK, Poland and Norway. Dyads will be randomised equally to standard care (SC), a home-based music programme plus SC, or a home-based reading programme plus SC for 12 weeks. The primary outcome is BPSD of PwD (measured using the Neuropsychiatric Inventory-Questionnaire). Secondary outcomes will examine relationship quality between CG and PwD, depression, resilience, competence, QoL for CG and QoL for PwD. Outcomes will be collected at baseline, at the end of the 12-week intervention and at 6 months post randomisation. Resource Utilisation in Dementia will be used to collect economic data across the life of the intervention and at 6-month follow-up. We hypothesise that the music programme plus SC will generate better results than SC alone (primary comparison) and the reading programme plus SC (secondary comparison).Ethics and disseminationEthical approval has been obtained for all countries. Results will be presented at national and international conferences and published in scientific journals and disseminated to consumer and caregiver representatives and the community.Trial registration numbersACTRN12618001799246p; NCT03907748

scholarly journals Feasibility randomised controlled trial of remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can): a study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e035648
Author(s):  
Saeed Moradian ◽  
Monika Krzyzanowska ◽  
Roma Maguire ◽  
Vishal Kukreti ◽  
Eitan Amir ◽  
...  
Keyword(s):  
Real Time ◽  
Symptom Management ◽  
Management System ◽  
Controlled Trial ◽  
Open Label ◽  
Symptom Monitoring ◽  
Group Assignment ◽  
Home Based ◽  
Chemotherapy Patients ◽  
Randomised Controlled

IntroductionTechnology is emerging as a solution to develop home-based, proactive ‘real-time’ symptom monitoring and management in cancer care. The Advanced Symptom Monitoring and Management System—Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities.Methods and analysisThis study is an open-label, prospective, mixed-method, Phase II, 2-arm parallel group assignment (ASyMS-Can vs usual care) feasibility study in patients with cancer receiving systemic (neo-adjuvant or adjuvant) chemotherapy at Princess Margaret Cancer Centre. A total of 114 patients will be recruited in oncology clinics prior to initiation of chemotherapy. Patients in both arms will complete a demographic and a set of questionnaires at enrolment, mid and end of treatment. Patients in intervention arm will be provided with an encrypted, secure, preprogrammed ASyMS phone for symptom reporting daily for the first 14 days of each chemotherapy treatment cycle up to sixth cycle (16 weeks). Feasibility metrics (recruitment, retention and protocol adherence) and outcomes to assess impact of ASyMS—Can include symptom severity, emotional distress, quality of life and acceptability to patients and clinicians.Ethics and disseminationThe study has received ethical and institutional approvals from the University Health Network. Dissemination will include presentations at national/international conferences, and publications in peer-reviewed journals.Trial registration numberNCT03335189.

scholarly journals Supporting people with dementia and their family caregivers through a home‐based, dyadic, multisensory stimulation intervention: A feasibility study

2020 ◽  
Vol 16 (S7) ◽  
Author(s):  
Patrick Pui Kin Kor ◽  
Clare Yu ◽  
Justina Yat Wa Liu ◽  
Daphne Sze Ki Cheung ◽  
Rick Yiu Cho Kwan ◽  
...  
Keyword(s):  
Family Caregivers ◽  
Feasibility Study ◽  
Multisensory Stimulation ◽  
People With Dementia ◽  
Home Based

scholarly journals Evaluation of an intervention addressing a reablement programme for older, community-dwelling persons in Sweden (ASSIST 1.0): a protocol for a feasibility study

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e025870
Author(s):  
Aileen Bergström ◽  
Lena Borell ◽  
Sebastiaan Meijer ◽  
Susanne Guidetti
Keyword(s):  
Home Care ◽  
Feasibility Study ◽  
Older Persons ◽  
Controlled Trial ◽  
Intervention Group ◽  
Full Scale ◽  
Community Dwelling ◽  
Care Staff ◽  
Control Group ◽  
Intervention Programme

IntroductionOlder persons with functional limitations often need assistance from home care staff to thrive and continue to live in their home environments. Reablement, a proactive, preventative approach administered by home care staff, stimulating active engagement of the older person, is often recommended. Even though reablement has a potential to become a new rehabilitation model and has been implemented in different countries in various degrees, there is a lack of knowledge regarding the process of establishing reablement, the theoretical underpinnings and the conditionality and outcomes in different contexts. This knowledge is needed before full-scale recommendations can be made for implementation in specific contexts.AimThis study protocol aims to present a feasibility study of the intervention, ASSIST 1.0, a theory-based reablement programme, which includes coaching of home care staff and digitally based smart products, in a Swedish context.Methods and analysisThis feasibility study will evaluate the perceived value and acceptability of ASSIST 1.0 intervention programme regarding fidelity, reach and dose, and potential outcomes by using a pretest and post-test design involving an intervention group and a control group (n=30) of older persons living at home, needing home care services. Qualitative interviews with home care staff delivering ASSIST and the older adults receiving the intervention as well as their significant others will be conducted to explore aspects affecting the intervention.Ethics and disseminationThis study has been approved by the regional ethics board. The results of the feasibility study will form the base for refinement of the ASSIST programme and for the subsequent planning of a full-scale randomised controlled trial investigating the effect of the programme on a larger scale. Dissemination will include peer-reviewed publications and presentations at national and international conferences as well as information to involved stakeholders.Trial registration numberNCT03505619

scholarly journals Protocol for an open-label feasibility study for a randomised controlled trial of vitamin D supplementation in Crohn’s Disease patients with vitamin D deficiency: D-CODE Feasiblity study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Jane Fletcher ◽  
Emma Bedson ◽  
Michaela Brown ◽  
Martin Hewison ◽  
Amelia Swift ◽  
...  
Keyword(s):  
Vitamin D ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Vitamin D Deficiency ◽  
Feasibility Study ◽  
Controlled Trial ◽  
List Type ◽  
Open Label ◽  
Inflammatory Bowel ◽  
Randomised Controlled

Abstract Background Crohn's disease (CD) is a principal form of inflammatory bowel disease, affecting approximately 1 in every 650 people in the UK. Vitamin D deficiency is common in approximately 57.7% of CD patients; with anaemia occurring in about 43% of patients. There is growing evidence that supplementing CD patients who are vitamin D deficient may be effective in reducing the severity of CD symptoms and reducing iron-deficiency anaemia. Nevertheless, National Institute for Health and Care Excellence guidance regarding the management of CD does not address vitamin D deficiency in these patients. The aims of the study are (1) to determine the prevalence of vitamin D deficiency in adults with CD in Birmingham, UK and (2) to assess the feasibility of conducting a multi-site randomised controlled trial in adult patients with CD and vitamin D deficiency. Methods D-CODE consists of two parts—a screening study and an open-label randomised controlled feasibility study. Vitamin D screening Three hundred patients, 18 years or older with CD will have a dried blood spot test to measure vitamin D levels. Dietary and sun exposure data will be collected. Eligible patients with low levels of vitamin D will be invited to participate in the feasibility study. Feasibility study Fifty participants with CD and vitamin D deficiency will be randomised to receive either a low (400 IU daily for 24 weeks) or high (3200 IU daily for 12 weeks then vitamin D3 800 IU daily for 12 weeks) dose of vitamin D3 oral supplementation. Patient-reported outcomes (Inflammatory Bowel Disease Questionnaire, EQ-5D-5L and Crohn’s Disease Activity Index Score) will be collected at weeks 0 and 24. Biochemical monitoring will take place at weeks 0, 12 and 24 and will measure 25-hydroxyvitamin D, corrected calcium, albumin, parathyroid hormone, hepcidin, other vitamin D metabolites, iron studies and C-reactive protein. Faecal calprotectin will be measured at weeks 0 and 24. Discussion A key aspect of D-CODE is the identification of vitamin D deficiency prior to supplementation. It is hoped that this feasibility study will lead to a definitive trial that will investigate the benefits of treating vitamin D deficiency in patients with CD. Trial registration The trial has been registered with EudraCT number 2018-003910-42, ClinicalTrials.gov identifier NCT03718182 and ISRCTN number 15717783.

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

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