A theory-based, task-oriented, outdoor walking programme for older adults with difficulty walking outdoors: protocol for the Getting Older Adults Outdoors (GO-OUT) randomised controlled trial

IntroductionA theory-based, task-oriented, community walking programme can increase outdoor walking activity among older adults to optimise functional independence, social participation and well-being. The study objective is to determine if there is a difference in the change in outdoor walking activity from baseline to 10 weeks, 5.5 months and 12 months after receiving a 1-day interactive workshop and outdoor walking programme (Getting Older Adults Outdoors (GO-OUT)) compared with the workshop and weekly reminders (WR) in older adults with difficulty walking outdoors.Methods and analysisA randomised controlled trial is being conducted in four urban Canadian communities. We will stratify 240 individuals by site and participant type (ie, individual vs spousal/friend pair) and randomise to either the GO-OUT or WR intervention. The GO-OUT intervention involves a 1-day workshop, where participants complete eight interactive stations to build knowledge and skills to walk outside, followed by a 10-week group outdoor walking programme (two 1-hour sessions/week) led by a physiotherapist or kinesiologist in parks. The WR intervention consists of the same workshop and 10 weekly telephone reminders to facilitate outdoor walking. The primary outcome measure is mean outdoor walking time in minutes/week derived from accelerometry and global positioning system data. GO-OUT is powered to detect an effect size of 0.4, given α=0.05, β=0.20, equal number of participants/group and a 20% attrition rate. Secondary outcomes include physical activity, lifespace mobility, participation, health-related quality of life, balance, leg strength, walking self-efficacy, walking speed, walking distance/endurance and mood.Ethics and disseminationGO-OUT has received ethics approval at all sites. A Data Safety Monitoring Board will monitor adverse events. We will disseminate findings through lay summaries, conference presentations and journal articles.Trial registration numberNCT03292510 (Pre-results).

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Motivating Structured walking Activity in people with Intermittent Claudication (MOSAIC): protocol for a randomised controlled trial of a physiotherapist-led, behavioural change intervention versus usual care in adults with intermittent claudication

BMJ Open ◽

10.1136/bmjopen-2019-030002 ◽

2019 ◽

Vol 9 (8) ◽

pp. e030002 ◽

Cited By ~ 1

Author(s):

Lindsay Bearne ◽

Melissa Galea Holmes ◽

Julie Bieles ◽

Saskia Eddy ◽

Graham Fisher ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Intermittent Claudication ◽

Controlled Trial ◽

Behavioural Change ◽

Walking Distance ◽

Walking Ability ◽

Walking Activity ◽

Walking Exercise ◽

Randomised Controlled

IntroductionWalking exercise is a recommended but underused treatment for intermittent claudication caused by peripheral arterial disease (PAD). Addressing the factors that influence walking exercise may increase patient uptake of and adherence to recommended walking. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of a physiotherapist-led behavioural change intervention on walking ability in adults with intermittent claudication (MOtivating Structured walking Activity in people with Intermittent Claudication (MOSAIC)) in comparison with usual care.Methods and analysisThe MOSAIC trial is a two-arm, parallel-group, single-blind RCT. 192 adults will be recruited from six National Health Service Hospital Trusts. Inclusion criteria are: aged ≥50 years, PAD (Ankle Brachial Pressure Index ≤0.90, radiographic evidence or clinician report) and intermittent claudication (San Diego Claudication Questionnaire), being able and willing to participate and provide informed consent. The primary outcome is walking ability (6 min walking distance) at 3 months. Outcomes will be obtained at baseline, 3 and 6 months by an assessor blind to group allocation. Participants will be individually randomised (n=96/group, stratified by centre) to receive either MOSAIC or usual care by an independent randomisation service. Estimates of treatment effects will use an intention-to-treat framework implemented using multiple regression adjusted for baseline values and centre.Ethics and disseminationThis trial has full ethical approval (London—Bloomsbury Research Ethics Committee (17/LO/0568)). It will be disseminated via patient forums, peer-reviewed publications and conference presentations.Trial registration numberISRCTN14501418

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Faculty Opinions recommendation of Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.737501295.793572409 ◽

2020 ◽

Author(s):

Guy Cammu

Keyword(s):

Older Adults ◽

Randomised Controlled Trial ◽

Neuromuscular Block ◽

Controlled Trial ◽

Pulmonary Complications ◽

Randomised Controlled ◽

Prolonged Surgery

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Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness

BMJ Open ◽

10.1136/bmjopen-2018-025692 ◽

2019 ◽

Vol 9 (1) ◽

pp. e025692 ◽

Cited By ~ 3

Author(s):

Corita R Grudzen ◽

Deborah J Shim ◽

Abigail M Schmucker ◽

Jeanne Cho ◽

Keith S Goldfeld

Keyword(s):

Quality Of Life ◽

Older Adults ◽

Palliative Care ◽

Randomised Controlled Trial ◽

Case Management ◽

Controlled Trial ◽

Chronic Obstructive ◽

Randomised Controlled ◽

End Stage

IntroductionEmergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.Methods and analysisThis is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their caregivers across nine EDs. Eligible patients: (1) have advanced cancer (metastatic solid tumour) or end-stage organ failure (New York Heart Association class III or IV heart failure, end-stage renal disease with glomerular filtration rate <15 mL/min/m2, or global initiative for chronic obstructive lung disease stage III, IV or oxygen-dependent chronic obstructive pulmonary disease); (2) speak English; (3) are scheduled for ED discharge or observation status; (4) reside locally; (5) have a working telephone and (6) are insured. Patients will be excluded if they: (1) have dementia; (2) have received hospice care or two or more palliative care visits in the last 6 months or (3) reside in a long-term care facility. We will use patient-level block randomisation, stratified by ED site and disease. Effectiveness will be compared by measuring the impact of each intervention on the specified outcomes. The primary outcome will measure change in patient quality of life.Ethics and disseminationInstitutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03325985; Pre-results.

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Evaluating the provision of Further Enabling Care at Home (FECH+) for informal caregivers of older adults discharged home from hospital: protocol for a multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-046600 ◽

2021 ◽

Vol 11 (6) ◽

pp. e046600

Author(s):

Anne-Marie Hill ◽

Rachael Moorin ◽

Susan Slatyer ◽

Christina Bryant ◽

Keith Hill ◽

...

Keyword(s):

Quality Of Life ◽

Older Adults ◽

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Informal Caregivers ◽

Care Recipient ◽

Care At Home ◽

Randomised Controlled

IntroductionThere are personal and societal benefits from caregiving; however, caregiving can jeopardise caregivers’ health. The Further Enabling Care at Home (FECH+) programme provides structured nurse support, through telephone outreach, to informal caregivers of older adults following discharge from acute hospital care to home. The trial aims to evaluate the efficacy of the FECH+ programme on caregivers’ health-related quality of life (HRQOL) after care recipients’ hospital discharge.Methods and analysisA multisite, parallel-group, randomised controlled trial with blinded baseline and outcome assessment and intention-to-treat analysis, adhering to Consolidated Standards of Reporting Trials guidelines will be conducted. Participants (N=925 dyads) comprising informal home caregiver (18 years or older) and care recipient (70 years or older) will be recruited when the care recipient is discharged from hospital. Caregivers of patients discharged from wards in three hospitals in Australia (one in Western Australia and two in Queensland) are eligible for inclusion. Participants will be randomly assigned to one of the two groups. The intervention group receive the FECH+ programme, which provides structured support and problem-solving for the caregiver after the care recipient’s discharge, in addition to usual care. The control group receives usual care. The programme is delivered by a registered nurse and comprises six 30–45 min telephone support sessions over 6 months. The primary outcome is caregivers’ HRQOL measured using the Assessment of Quality of Life—eight dimensions. Secondary outcomes include caregiver preparedness, strain and distress and use of healthcare services. Changes in HRQOL between groups will be compared using a mixed regression model that accounts for the correlation between repeated measurements.Ethics and disseminationParticipants will provide written informed consent. Ethics approvals have been obtained from Sir Charles Gairdner and Osborne Park Health Care Group, Curtin University, Griffith University, Gold Coast Health Service and government health data linkage services. Findings will be disseminated through presentations, peer-reviewed journals and conferences.Trial registration numberACTRN12620000060943.

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Effectiveness of an eHealth self-management tool for older adults with multimorbidity (KeepWell): protocol for a hybrid effectiveness–implementation randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-048350 ◽

2021 ◽

Vol 11 (2) ◽

pp. e048350

Author(s):

Monika Kastner ◽

Julie Makarski ◽

Leigh Hayden ◽

Jemila S Hamid ◽

Jayna Holroyd-Leduc ◽

...

Keyword(s):

Older Adults ◽

Chronic Disease ◽

Randomised Controlled Trial ◽

Disease Management ◽

Chronic Conditions ◽

Controlled Trial ◽

Management Tool ◽

Self Management ◽

Plain Language ◽

Randomised Controlled

IntroductionIn response to the burden of chronic disease among older adults, different chronic disease self-management tools have been created to optimise disease management. However, these seldom consider all aspects of disease management are not usually developed specifically for seniors or created for sustained use and are primarily focused on a single disease. We created an eHealth self-management application called ‘KeepWell’ that supports seniors with complex care needs in their homes. It incorporates the care for two or more chronic conditions from among the most prevalent high-burden chronic diseases.Methods and analysisWe will evaluate the effectiveness, cost and uptake of KeepWell in a 6-month, pragmatic, hybrid effectiveness–implementation randomised controlled trial. Older adults age ≥65 years with one or more chronic conditions who are English speaking are able to consent and have access to a computer or tablet device, internet and an email address will be eligible. All consenting participants will be randomly assigned to KeepWell or control. The allocation sequence will be determined using a random number generator.Primary outcome is perceived self-efficacy at 6 months. Secondary outcomes include quality of life, health background/status, lifestyle (nutrition, physical activity, caffeine, alcohol, smoking and bladder health), social engagement and connections, eHealth literacy; all collected via a Health Risk Questionnaire embedded within KeepWell (intervention) or a survey platform (control). Implementation outcomes will include reach, effectiveness, adoption, fidelity, implementation cost and sustainability.Ethics and disseminationEthics approval has been received from the North York General Hospital Research and Ethics Board. The study is funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health. We will work with our team to develop a dissemination strategy which will include publications, presentations, plain language summaries and an end-of-grant meeting.Trial registration numberNCT04437238.

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Feasibility of a specific task-oriented training versus its combination with manual therapy on balance and mobility in people post stroke at the chronic stage: study protocol for a pilot randomised controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00886-0 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Kristina Traxler ◽

Franz Schinabeck ◽

Eva Baum ◽

Edith Klotz ◽

Barbara Seebacher

Keyword(s):

Randomised Controlled Trial ◽

Ankle Joint ◽

Manual Therapy ◽

Controlled Trial ◽

Daily Activities ◽

Control Group ◽

Chronic Stage ◽

Post Stroke ◽

Randomised Controlled ◽

Task Oriented

Abstract Background Large studies have shown that stroke is among the most relevant causes of acquired adult disability. Walking and balance impairment in stroke survivors often contribute to a restriction in daily activities and social participation. Task-oriented training (TOT) is an effective treatment strategy and manual therapy (MT) is used successfully to enhance ankle joint flexibility in this population. No study, however, has compared TOT against its combination with MT in a randomised controlled trial. Aims of this pilot study are therefore to explore the feasibility of a full-scale RCT using predefined feasibility criteria. Secondary aims are to explore the preliminary effects of specific TOT with a combined specific TOT-MT versus a control group in people post stroke. Methods This is a protocol of a 4-week prospective randomised controlled parallel pilot trial in people post stroke at the chronic stage with limited upper ankle joint mobility and an impairment in balance and mobility. At a German outpatient therapy centre using 1:1:1 allocation, 36 patients will be randomised into one of three groups: 15-min talocrural joint MT plus 30-min specific TOT (group A), 45-min specific TOT (group B), and controls (group C). Training will be goal-oriented including tasks that are based on daily activities and increased in difficulty utilising predefined progression criteria based on patients’ skill levels. Interventions will be provided face-to-face 2 times per week, for 4 weeks, in addition to 20-min concurrent x4 weekly home-based training sessions. Data will be collected by blinded assessors at baseline, post-intervention and 4-week follow-up. The primary outcome will be feasibility assessed by recruitment, retention and adherence rates, compliance, adverse events, falls and the acceptability of the intervention. Secondary outcomes will be walking speed, single and dual tasking functional mobility, ankle range of motion, disability and health-related quality of life. Discussion Feasibility provided, results from this study will be used to calculate the sample size of a larger randomised controlled trial to investigate the effects of specific TOT and specific TOT-MT compared to a post stroke control group. Trial registration German Clinical Trials Register, DRKS00023068. Registered on 21.09.2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068.

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