scholarly journals Dementia Early-Stage Cognitive Aids New Trial (DESCANT) of memory aids and guidance for people with dementia: randomised controlled trial

2021 ◽  
pp. jnnp-2021-326748
Author(s):  
Paul Clarkson ◽  
Rosa Pitts ◽  
Saiful Islam ◽  
Julie Peconi ◽  
Ian Russell ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Activities Of Daily Living ◽  
Daily Living ◽  
Early Stage ◽  
Controlled Trial ◽  
Health Board ◽  
Memory Aids ◽  
People With Dementia ◽  
Secondary Outcomes ◽  
Randomised Controlled

BackgroundCommon memory aids for people with dementia at home are recommended. However, rigorous evaluation is lacking, particularly what guidance or support is valued.ObjectiveTo investigate effects of memory aids and guidance by dementia support practitioners (DSPs) for people in early-stage dementia through a pragmatic, randomised controlled trial.MethodsOf 469 people with mild-to-moderate dementia and their informal carers, 468 were randomised to a DSP with memory aids or to usual care plus existing dementia guide. Allocation was stratified by Trust/Health Board; time since first attendance at memory service; gender; age; and living with primary carer or not. Primary outcome was Bristol Activities of Daily Living Scale (BADLS) Score at 3 and 6 months (primary end-point). Secondary outcomes for people with dementia: quality of life (CASP-19; DEMQOL); cognition and functioning (Clinical Dementia Rating Scale; S-MMSE); capability (ICECAP-O); social networks (LSNS-R); and instrumental daily living activities (R-IDDD). Secondary outcomes for carers: psychological health (GHQ-12); sense of competence (SSCQ).ResultsDSPs were successfully trained, compliance was good and welcomed by participants. Mean 6 months BADLS Score increased to 14.6 (SD: 10.4) in intervention and 12.6 (SD: 8.1) in comparator, indicative of greater dependence in the activities of daily living. Adjusted between-group difference was 0.38 (95% CI: −0.89 to 1.65, p=0.56). Though this suggests greater dependency in the intervention group the difference was not significant. No differences were found in secondary outcomes.ConclusionsThis intervention did not maintain independence in the activities of daily living with no improvement in other outcomes for people with dementia or carers.Trial registration numberCurrent Controlled Trials ISRCTN12591717.

scholarly journals Effect of occupation-based interventions in patients with haematopoietic malignancies undergoing chemotherapy: A pilot randomised controlled trial

2018 ◽  
Vol 31 (2) ◽  
pp. 97-105
Author(s):  
Akira Sagari ◽  
Yuta Ikio ◽  
Nobuko Imamura ◽  
Kayoko Deguchi ◽  
Toko Sakai ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Decision Making ◽  
Randomised Controlled Trial ◽  
Activities Of Daily Living ◽  
Daily Living ◽  
Controlled Trial ◽  
Intervention Group ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Background/objective Chemotherapy for cancer negatively affects activities of daily living and quality of life. This study aimed to validate and compare the efficacy of two different interventions in patients with haematopoietic malignancies undergoing chemotherapy: (1) occupation-based interventions, designed using the Aid for Decision-making in Occupation Choice (ADOC) (an iPAD application) and (2) impairment-based interventions. ADOC helps promote decision-making during activities and participation in occupation-based goal setting. The impairment-based intervention group served as the comparison group and underwent impairment-based interventions focusing on dysfunction. Methods In this single-blinded pilot randomised controlled trial, 19 participants received an occupation-based intervention (n = 9) or an impairment-based intervention (n = 10). The treatment period comprised two sessions. Recruitment, compliance and outcome completion rates were calculated for the study. Effect sizes were examined for outcomes regarding physical performance, instrumental activities of daily living and quality of life as evaluated by a blinded assessor. Results In this study, 24.8% (28/113) of the eligible patients with haematopoietic malignancies were enrolled, and 67.9% (19/28) of these were retained up to the post-assessment stage. Recruitment (25%) and compliance (68%) rates were satisfactory. The Functional Assessment of Cancer Therapy-General emotional well-being and total scores were significantly higher for the occupation-based intervention group than for the impairment-based intervention group (both p < 0.05; d = 0.54, d = 0.51, respectively). Other outcomes showed no significant differences. Conclusion Occupation-based interventions designed using the ADOC application were useful for patients with haematopoietic malignancies.

scholarly journals Resource use of healthcare services 1 year after stroke: a secondary analysis of a cluster-randomised controlled trial of a client-centred activities of daily living intervention

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e022222 ◽  
Author(s):  
Malin Tistad ◽  
Maria Flink ◽  
Charlotte Ytterberg ◽  
Gunilla Eriksson ◽  
Susanne Guidetti ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Activities Of Daily Living ◽  
Daily Living ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Cluster Randomised Controlled Trial ◽  
Healthcare Services ◽  
First Year ◽  
Cluster Randomised ◽  
Randomised Controlled

ObjectiveThe objective of the study was to compare the total use of healthcare services in the course of the first year after a stroke between participants who, after the acute care, had received occupational therapy as a client-centred activities of daily living (ADL) intervention (CADL) and participants who had received usual ADL intervention (UADL).DesignA secondary analysis of a multicentre cluster-randomised controlled trial (RCT).SettingPrimary and secondary care in Sweden.ParticipantsParticipants were included if they: (1) had received CADL or UADL in the RCT, either as inpatients in geriatric rehabilitation units or in their own homes, and (2) data could be retrieved about their use of healthcare services provided by the county council from computerised registers.InterventionsCADL or UADL.Outcome measuresInpatient and outpatient healthcare in the course of the first year after stroke.ResultsParticipants from 7 of the 16 units included in the RCT met the criteria. Participants in the CADL group (n=26) who received geriatric inpatient rehabilitation had a shorter length of hospital stay (p=0.03) than participants in the UADL group (n=46), and the CADL group with home rehabilitation (n=13) had fewer outpatient contacts (p=0.01) compared with the UADL group (n=25). Multiple regression analyses showed that in four of the models, a higher age was associated with a lower use of healthcare services. The use of healthcare services was also associated (some of the models) with dependence in ADL, stroke severity and type of rehabilitation received, CADL or UADL.ConclusionsThe provision of client-centred occupational therapy after stroke did not appear to increase the use of healthcare services during the first year after stroke.rrrrrTrial registration numberNCT01417585.

scholarly journals "More Air – Better Performance – Faster Recovery": Study Protocol for Randomised Controlled Trial of the Effect of Post-stroke Inspiratory Muscle Training for Adults

2021 ◽  
Author(s):  
Susanne Lillelund Sørensen ◽  
Simon Svanborg Kjeldsen ◽  
Sine Secher Mortensen ◽  
Ulla Torp Hansen ◽  
Dorthe Hansen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Activities Of Daily Living ◽  
Daily Living ◽  
Controlled Trial ◽  
Intervention Group ◽  
Functional Independence ◽  
Inspiratory Muscle ◽  
Inspiratory Muscle Training ◽  
Muscle Training ◽  
Randomised Controlled

Abstract Background: Stroke results in varying physical, cognitive, emotional and/or social disabilities in the short and long term alike. Motor impairments are important, persistent consequences of stroke and include, among others, decreased respiratory muscle function, decreased ability to expand the thorax and postural dysfunction. These deficits affect the patient's ability to perform daily activities, produce fatigue and reduce endurance and quality of life. Inspiratory muscle training (IMT) aims to improve the strength and endurance of the diaphragm and the external intercostal muscles. The objective of this study was to investigate i) the effect of three weeks of IMT on maximal inspiratory pressure (MIP) in adults having suffered a stroke, and ii) the effects of three weeks of IMT on the degree of dependency in activities of daily living, endurance in gait, fatigue, voice volume, phonation endurance and expiratory function.Methods/Design: This is a randomised controlled trial (RCT) comparing IMT with conventional neurorehabilitation (usual practise). The trial will include 80 patients with reduced MIP hospitalised at a specialised neurorehabilitation hospital in Denmark. The intervention group will receive IMT sessions, exercising at 30% of MIP. Patients in the intervention group will perform two daily sessions (one session of IMT with Threshold IMT consisting of two times 15 inspirations at normal breathing rhythm (5-10 min)), seven days a week for three weeks. Training can be with or without physiotherapist supervision. Study outcomes: MIP assessed by the Power Breath, Functional Independence Measurement, The 6-minute Walk Test, the Fatigue Severity Scale and average voice volume. Expiratory function will be assessed using spirometry. All assessments will be conducted at baseline and three weeks (at termination of the intervention) and three months after the intervention has concluded.Discussion: The primary purpose of this study is to assess the effect of IMT interventions in patients with reduced MIP following stroke; secondarily, to assess the effect of IMT on the degree of dependency in activities of daily living, endurance in gait, fatigue, voice volume, phonation endurance and expiratory capacity. Hereby, this study accepts the call for further research.Trial registration: ClinicalTrials.gov NCT04686019. Registered 28.12.2020, https://www.clinicaltrials.gov/ct2/show/NCT04686019

scholarly journals Occupational therapy addressing the ability to perform activities of daily living among persons living with chronic conditions: a randomised controlled pilot study of ABLE 2.0

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Vita Hagelskjær ◽  
Kristina Tomra Nielsen ◽  
Cecilie von Bülow ◽  
Maud Graff ◽  
Eva Ejlersen Wæhrens
Keyword(s):  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Occupational Therapy ◽  
Activities Of Daily Living ◽  
Chronic Conditions ◽  
Daily Living ◽  
Controlled Trial ◽  
Outcome Measurements ◽  
Needed Information ◽  
Randomised Controlled

Abstract Background The ABLE intervention was developed to enhance the ability to perform activities of daily living (ADL) tasks among persons living with chronic conditions. ABLE is a generic, home-based, individualised, 8-week occupational therapy intervention program, developed to be delivered in Danish municipalities. In a previous study, the feasibility of ABLE was evaluated in terms of content and delivery. In this pilot study, the remaining feasibility aspects of a randomised controlled trial including (i) trial procedures (recruitment and retention), (ii) randomisation, (iii) adherence to program, (iv) feasibility of additional outcome measurements, and (iv) access to information on usual occupational therapy were evaluated. Methods The study was conducted in a Danish municipality, using a two-armed parallel randomised controlled design, planning a recruitment strategy including 20 persons living with one/more chronic conditions and experiencing problems performing ADL. The following progression criteria were used to determine if a future full-scale randomised controlled trial was feasible: (i) recruitment (50% met the eligibility criteria) and retention (80%), (ii) randomisation (80% accepted randomisation, procedure was executed as planned), (iii) adherence to program (100% followed the treatment protocol), (iv) outcome measurements (80% of the participants delivered relevantly and fully answered questionnaires), and (v) usual occupational therapy (extraction of needed information was successful). Results Due to the COVID-19 pandemic, the study was truncated resulting in limited but sufficient data to answer most of the study questions. (i) Eighteen of 37 eligible persons (48.6%) were recruited; of those treated (n = 6), all remained (100%); (ii) 18 accepted randomisation (100%), and procedure was effective; (iii) ABLE was delivered with adherence (100%); (iv) 92.3–100% of the participants gave relevant and complete answers in two of three questionnaires; and (v) needed information on usual occupational therapy was extractable in seven of nine aspects. Conclusions Proceeding to full-scale trial is recommendable; however, a few adjustments on outcome measurements, inclusion criteria and extraction of information on usual occupational therapy are needed. Trial registration The study was registered at ClinicalTrials.gov (Identifier: NCT04295837) on December 5th, 2019. Retrospectively registered.

scholarly journals Evaluating a complex intervention addressing ability to perform activities of daily living among persons with chronic conditions: study protocol for a randomised controlled trial (ABLE)

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e051722
Author(s):  
Vita Hagelskjær ◽  
Kristina Tomra Nielsen ◽  
Cecilie von Bulow ◽  
Lisa Gregersen Oestergaard ◽  
Maud Graff ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Occupational Therapy ◽  
Activities Of Daily Living ◽  
Chronic Conditions ◽  
Daily Living ◽  
Controlled Trial ◽  
Service Agency ◽  
Life Years ◽  
Randomised Controlled

IntroductionThe need to develop and evaluate interventions, addressing problems performing activities of daily living (ADL) among persons with chronic conditions, is evident. Guided by the British Medical Research Council’s guidance on how to develop and evaluate complex interventions, the occupational therapy programme (A Better everyday LifE (ABLE)) was developed and feasibility tested. The aim of this protocol is to report the planned design and methods for evaluating effectiveness, process and cost-effectiveness of the programme.Methods and analysisThe evaluation is designed as a randomised controlled trial with blinded assessors and investigators. Eighty participants with chronic conditions and ADL problems are randomly allocated to ABLE or usual occupational therapy. Data for effectiveness and cost-effectiveness evaluations are collected at baseline (week 0), post intervention (week 10) and follow-up (week 26). Coprimary outcomes are self-reported ADL ability (ADL-Interview (ADL-I) performance) and observed ADL motor ability (Assessment of Motor and Process Skills (AMPS)). Secondary outcomes are perceived satisfaction with ADL ability (ADL-I satisfaction); and observed ADL process ability (AMPS). Explorative outcomes are occupational balance (Occupational Balance Questionnaire); perceived change (Client-Weighted Problems Questionnaire) and general health (first question of the MOS 36-item Short Form Survey Instrument). The process evaluation is based on quantitative data from registration forms and qualitative interview data, collected during and after the intervention period. A realist evaluation approach is applied. A programme theory expresses how context (C) and mechanisms (M) in the programme may lead to certain outcomes (O), in so-called CMO configurations. Outcomes in the cost-effectiveness evaluation are quality-adjusted life years (EuroQool 5-dimension) and changes in ADL ability (AMPS, ADL-I). Costs are estimated from microcosting and national registers.Ethics and disseminationDanish Data Protection Service Agency approval: Journal-nr.: P-2020-203. The Ethical Committee confirmed no approval needed: Journal-nr.: 19 045 758. Dissemination for study participants, in peer-reviewed journals and conferences.Trial registration numberNCT04295837

scholarly journals Communicating personalised statin therapy-effects as 10-year CVD-risk or CVD-free life-expectancy: does it improve decisional conflict? Three-armed, blinded, randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e041673
Author(s):  
Nicole E M Jaspers ◽  
Frank L J Visseren ◽  
Yolanda van der Graaf ◽  
Yvo M Smulders ◽  
Olga C Damman ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomised Controlled Trial ◽  
Life Expectancy ◽  
Statin Therapy ◽  
Controlled Trial ◽  
Decisional Conflict ◽  
P Value ◽  
Cvd Risk ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveTo determine whether communicating personalised statin therapy-effects obtained by prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable cardiovascular disease (CVD) compared with standard (non-personalised) therapy-effects.DesignHypothesis-blinded, three-armed randomised controlled trialSetting and participants303 statin users with stable CVD enrolled in a cohortInterventionParticipants were randomised in a 1:1:1 ratio to standard practice (control-group) or one of two intervention arms. Intervention arms received standard practice plus (1) a personalised health profile, (2) educational videos and (3) a structured telephone consultation. Intervention arms received personalised estimates of prognostic changes associated with both discontinuation of current statin and intensification to the most potent statin type and dose (ie, atorvastatin 80 mg). Intervention arms differed in how these changes were expressed: either change in individual 10-year absolute CVD risk (iAR-group) or CVD-free life-expectancy (iLE-group) calculated with the SMART-REACH model (http://U-Prevent.com).OutcomePrimary outcome was patient decisional conflict score (DCS) after 1 month. The score varies from 0 (no conflict) to 100 (high conflict). Secondary outcomes were collected at 1 or 6 months: DCS, quality of life, illness perception, patient activation, patient perception of statin efficacy and shared decision-making, self-reported statin adherence, understanding of statin-therapy, post-randomisation low-density lipoprotein cholesterol level and physician opinion of the intervention. Outcomes are reported as median (25th– 75th percentile).ResultsDecisional conflict differed between the intervention arms: median control 27 (20–43), iAR-group 22 (11–30; p-value vs control 0.001) and iLE-group 25 (10–31; p-value vs control 0.021). No differences in secondary outcomes were observed.ConclusionIn patients with clinically manifest CVD, providing personalised estimations of treatment-effects resulted in a small but significant decrease in decisional conflict after 1 month. The results support the use of personalised predictions for supporting decision-making.Trial registrationNTR6227/NL6080.

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

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