Effect of a structured course involving goal management training in older adults: A randomised controlled trial

IntroductionCompromised integrity of the brain due to paediatric acquired brain injury (pABI) has been associated with cognitive impairment, particularly executive dysfunction, in addition to somatic and emotional symptoms and reduced everyday function. Goal Management Training (GMT) is a cognitive rehabilitation intervention for improving executive function (EF) that has received empirical support in studies of adults with ABI. The purpose of the present study is to determine the efficacy of a recently developed paediatric version of GMT (pGMT) for children and adolescents with ABI and reported executive dysfunction.Methods and analysisThis study protocol describes a parallel randomised controlled trial including allocation concealment and assessor blinding. Eighty survivors after pABI, aged 10–17 years at the time of intervention, will be recruited. Participants will be randomly allocated to either pGMT (n=40) or a psychoeducative control intervention (n=40; paediatric Brain Health Workshop). Both interventions consist of seven group sessions for participants and parents, followed by external cueing and telephone counselling. The study also includes involvement of teachers. Assessments will be performed at baseline, immediately postintervention and at 6 months’ follow-up. Primary outcome measure will be changes in daily life EF as reported by parents (The Behavior Rating Inventory of Executive Function). Secondary outcomes include other assessments of EF (neuropsychological tests and questionnaires). Furthermore, we aim to assess generalisation effects of pGMT on other cognitive functions, as well as emotional, behavioural, adaptive and family function, academic performance, fatigue and quality of life.Ethics and disseminationResults from this study will be disseminated to relevant research, clinical, health service and patient communities through publications in peer-reviewed and popular science journals, in addition to presentations at scientific conferences. The study will be conducted in accordance with the Helsinki declaration and the Ethical Research Involving Children (ChildWatch International and Unicef). In accordance to Good Clinical Practice our study includes safety and quality monitoring guarantees in compliance with research ethics and safety. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials 2010 statement and Standard Protocol Items for Reporting in Trials recommendations, in addition to being registered at ClinicalTrials.gov. The study has been approved by the Regional Committees for Medical and Health Research Ethics Norway (2017/772).Trial registration numberNCT03215342.

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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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