scholarly journals Matching depression management to severity prognosis in primary care: results of the Target-D randomised controlled trial

2020 ◽  
pp. BJGP.2020.0783
Author(s):  
Susan Fletcher ◽  
Patty Chondros ◽  
Konstancja Densley ◽  
Elizabeth Murray ◽  
Christopher Dowrick ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Symptom Severity ◽  
Controlled Trial ◽  
Psychological Therapy ◽  
Management Options ◽  
Waiting Room ◽  
Serious Adverse Events ◽  
Randomised Controlled

BackgroundMental health treatment rates are increasing, but the burden of disease has not reduced. Tools to support efficient resource distribution are required.AimTo investigate whether a person-centred e-health (Target-D) platform matching depression care to symptom severity prognosis can improve depressive symptoms relative to usual care.Design and settingStratified individually randomised controlled trial in 14 general practices in Melbourne, Australia, from April 2016 to February 2019. In total, 1868 participants aged 18–65 years who had current depressive symptoms; internet access; no recent change to antidepressant; no current antipsychotic medication; and no current psychological therapy were randomised (1:1) via computer-generated allocation to intervention or usual care.MethodThe intervention was an e-health platform accessed in the GP waiting room, comprising symptom feedback, priority-setting, and prognosis-matched management options (online self-help, online guided psychological therapy, or nurse-led collaborative care). Management options were flexible, neither participants nor staff were blinded, and there were no substantive protocol deviations. The primary outcome was depressive symptom severity (9-item Patient Health Questionnaire [PHQ-9]) at 3 months.ResultsIn intention to treat analysis, estimated between- arm difference in mean PHQ-9 scores at 3 months was −0.88 (95% confidence interval [CI] = −1.45 to −0.31) favouring the intervention, and −0.59 at 12 months (95% CI = −1.18 to 0.01); standardised effect sizes of −0.16 (95% CI = −0.26 to −0.05) and −0.10 (95% CI = −0.21 to 0.002), respectively. No serious adverse events were reported.ConclusionMatching management to prognosis using a person-centred e-health platform improves depressive symptoms at 3 months compared to usual care and could feasibly be implemented at scale. Scope exists to enhance the uptake of management options.

scholarly journals Effect of PEP flute self-care versus usual care in early covid-19: non-drug, open label, randomised controlled trial in a Danish community setting

BMJ ◽  
2021 ◽  
pp. e066952
Author(s):  
Annette Mollerup ◽  
Marius Henriksen ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Mette Kildevæld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Symptom Severity ◽  
Controlled Trial ◽  
Self Care ◽  
Community Dwelling ◽  
Care Group ◽  
Open Label ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Objective To determine whether positive expiratory pressure (PEP) by PEP flute self-care is effective in reducing respiratory symptoms among community dwelling adults with SARS-CoV-2 infection and early stage covid-19. Design Non-drug, open label, randomised controlled trial. Setting Capital Region and Region Zealand in Denmark from 6 October 2020 to 26 February 2021. Participants Community dwelling adults, able to perform self-care, with a new SARS-CoV-2 infection (verified by reverse transcription polymerase chain reaction tests) and symptoms of covid-19. Intervention Participants were randomised to use PEP flute self-care in addition to usual care or have usual care only. Randomisation was based on permuted random blocks in a 1:1 ratio, stratified for sex and age (<60 or ≥60 years). The PEP self-care group was instructed to use a PEP flute three times per day during the 30 day intervention. Main outcome measures Primary outcome was a change in symptom severity from baseline to day 30, as assessed by the self-reported COPD (chronic obstructive pulmonary disease) assessment test (CAT), which was adjusted for baseline values and stratification factors. Participants completed the CAT test questionnaire every day online. Secondary outcomes were self-reported urgent care visits due to covid-19, number of covid-19 related symptoms, and change in self-rated health, all within 30-days’ follow-up. Results 378 participants were assigned to the PEP flute self-care intervention (n=190) or usual care only (n=188). In the PEP self-care group, the median number of days with PEP flute use was 21 days (interquartile range 13-25). For the intention-to-treat population, a group difference was observed in changes from baseline in CAT scores of −1.2 points (95% confidence interval −2.1 to −0.2; P=0.017) in favour of the PEP flute self-care group. At day 30, the PEP flute self-care group also reported less chest tightness, less dyspnoea, more vigour, and higher level of daily activities, but these differences were small, and no consistent effects were seen on the secondary outcomes. No serious adverse events were reported. Conclusions In community dwelling adults with early covid-19, PEP flute self-care had a significant, yet marginal and uncertain clinical effect on respiratory symptom severity, as measured by CAT scores. Trial registration ClinicalTrials.gov NCT04530435 .

scholarly journals Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e042620
Author(s):  
Taylor L Stallings ◽  
Jennifer S Temel ◽  
Tamar A Klaiman ◽  
Michael K Paasche-Orlow ◽  
Margarita Alegria ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Advance Care Planning ◽  
Controlled Trial ◽  
Care Planning ◽  
Management Options ◽  
Pilot Randomised Controlled Trial ◽  
Advance Care ◽  
Poor Functional Status ◽  
Randomised Controlled

IntroductionPredialysis education for patients with advanced chronic kidney disease (CKD) typically focuses narrowly on haemodialysis and peritoneal dialysis as future treatment options. However, patients who are older or seriously ill may not want to pursue dialysis and/or may not benefit from this treatment. Conservative kidney management, a reasonable alternative treatment, and advance care planning (ACP) are often left out of patient education and shared decision-making. In this study, we will pilot an educational intervention (Conservative Kidney Management Options and Advance Care Planning Education—COPE) to improve knowledge of conservative kidney management and ACP among patients with advanced CKD who are older and/or have poor functional status.Methods and analysisThis is a single-centre pilot randomised controlled trial at an academic centre in Philadelphia, PA. Eligible patients will have: age ≥70 years and/or poor functional status (as defined by Karnofsky Performance Index Score <70), advanced CKD (estimated glomerular filtration rate<20 mL/min/1.73 m2), prefer to speak English during clinical encounters and self-report as black or white race. Enrolled patients will be randomised 1:1, with stratification by race, to receive enhanced usual care or usual care and in-person education about conservative kidney management and ACP (COPE). The primary outcome is change in knowledge of CKM and ACP. We will also explore intervention feasibility and acceptability, change in communication of preferences and differences in the intervention’s effects on knowledge and communication of preferences by race. We will assess outcomes at baseline, immediately post-education and at 2 and 12 weeks.Ethics and disseminationThis protocol has been approved by the Institutional Review Board at the University of Pennsylvania. We will obtain written informed consent from all participants. The results from this work will be presented at academic conferences and disseminated through peer-reviewed journals.Trial registration numberThis trial is registered at ClinicalTrials.gov under NCT03229811.

scholarly journals Supporting wellbeing through peer-befriending (SUPERB) for people with aphasia: A feasibility randomised controlled trial

2021 ◽  
pp. 026921552199567 ◽  
Author(s):  
Katerina Hilari ◽  
Nicholas Behn ◽  
Kirsty James ◽  
Sarah Northcott ◽  
Jane Marshall ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Significant Others ◽  
Community Services ◽  
Serious Adverse Events ◽  
Post Stroke ◽  
Feasibility Randomised Controlled Trial ◽  
Low Levels ◽  
Randomised Controlled

Objective: To determine the feasibility and acceptability of peer-befriending, for people with aphasia. Design: Single-blind, parallel-group feasibility randomised controlled trial comparing usual care to usual care + peer-befriending. Participants and setting: People with aphasia post-stroke and low levels of distress, recruited from 5 NHS Hospitals and linked community services; their significant others; and 10 befrienders recruited from community. Intervention: Six 1-hour peer-befriending visits over three months. Main measures: Feasibility parameters included proportion eligible of those screened; proportion consented; missing data; consent and attrition rates. Acceptability was explored through qualitative interviews. Outcomes for participants and significant others were measured at baseline, 4- and 10-months; for peer-befrienders before training and after one/two cycles of befriending. Results: Of 738 patients identified, 75 were eligible of 89 fully screened (84%), 62 consented (83% of eligible) and 56 randomised. Attrition was 16%. Adherence was high (93% attended ⩾2 sessions, 81% all six). The difference at 10 months on the GHQ-12 was 1.23 points on average lower/better in the intervention arm (95% CI 0.17, −2.63). There was an 88% decrease in the odds of GHQ-12 caseness (95% CI 0.01, 1.01). Fourty-eight significant others and 10 peer-befrienders took part. Procedures and outcome measures were acceptable. Serious adverse events were few ( n = 10, none for significant others and peer-befrienders) and unrelated. Conclusions: SUPERB peer-befriending for people with aphasia post-stroke experiencing low levels of distress was feasible. There was preliminary evidence of benefit in terms of depression. Peer-befriending is a suitable intervention to explore further in a definitive trial. Clinical trial registration-URL: http://www.clinicaltrials.gov Unique identifier: NCT02947776 Subject terms: Translational research, mental health, rehabilitation, quality and outcomes, stroke

scholarly journals An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Audrey Rankin ◽  
◽  
Cathal A. Cadogan ◽  
Heather E. Barry ◽  
Evie Gardner ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Video ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

scholarly journals 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 ◽  
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.

scholarly journals Improving Depressive Symptoms through Personalised Exercise and Activation (IDEA): Study Protocol for a Randomised Controlled Trial

2021 ◽  
Vol 18 (12) ◽  
pp. 6306
Author(s):  
Aitana García-Estela ◽  
Natalia Angarita-Osorio ◽  
Sandra Alonso ◽  
Maria Polo ◽  
Maria Roldán-Berengué ◽  
...  
Keyword(s):  
Physical Activity ◽  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Physical Health ◽  
Controlled Trial ◽  
Exercise Group ◽  
Global Functioning ◽  
Motivational Messages ◽  
Randomised Controlled ◽  
Group Programme

Individuals who suffer from depressive symptoms experience a substantial impact on psychosocial functioning, physical health, mortality, and quality of life. In the search for therapeutic strategies, exercise has been found to play a relevant part in its treatment. However, the promotion of exercise entails adherence difficulties that arose out of the tendency towards sedentarism led by symptomatology. Personalised exercise plans on top of usual care have the potential to enhance behavioural changes and mental health. The present study aims at evaluating the changes in functioning deriving from a blended intervention merging a psychological intervention with a personalised exercise programme based on medical assessment. We will conduct a three-arm randomised controlled trial in which 172 participants suffering from mild–moderate depressive symptoms will be allocated to Intervention A (personalised exercise group programme + app with motivational messages), B (personalised exercise group programme + app with no motivational messages) or control group (app with no motivational messages). Data regarding global functioning, well-being, symptoms, physical activity, and exercise capacity will be collected at baseline, 4, 12, and 36 weeks. The results of this trial will provide information about whether this physical activity support programme may be efficient for improving mental and physical health outcomes. Trial registration: ClinicalTrials.gov NCT04857944 (accessed on 15 April 2021). Registered April 2021.

scholarly journals PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050582
Author(s):  
Annette Mollerup ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Marius Henriksen ◽  
Mette Kildevaeld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Admission ◽  
Usual Care ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Self Care ◽  
Secondary Outcome ◽  
Link Type ◽  
Randomised Controlled ◽  
At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

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