scholarly journals Effect of singing interventions on symptoms of postnatal depression: three-arm randomised controlled trial

2018 ◽  
Vol 212 (2) ◽  
pp. 119-121 ◽  
Author(s):  
D. Fancourt ◽  
R. Perkins
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Psychosocial Intervention ◽  
Postnatal Depression ◽  
Controlled Trial ◽  
Trial Registration ◽  
Randomised Controlled ◽  
Group Play

SummaryThis study assessed whether a novel psychosocial intervention could reduce symptoms of postnatal depression (PND) in the first 40 weeks post-birth. Analyses were carried out of 134 mothers with symptoms of PND randomised into 10 weeks of group singing workshops or group play workshops for them and their babies, or usual care (trial registration: NCT02526407). Overall, among all mothers with symptoms of PND, there was a non-significant faster improvement in symptoms in the singing group (F4,262 = 1.66, P = 0.16, η2 = 0.012). When isolating mothers with moderate–severe symptoms of PND, this result became significant, with a faster improvement in symptoms in the singing group (F3.9,139.8 = 2.74, P = 0.033, η2 = 0.028).Declaration of interestNone.

scholarly journals Prescribed exercise regimen versus usual care and hypochlorous acid wound solution versus placebo for treating venous leg ulcers: study protocol for a randomised controlled trial (Factorial4VLU)

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043420
Author(s):  
Andrew Jull ◽  
Angela Wadham ◽  
Chris Bullen ◽  
Varsha Parag ◽  
John G M Parsons ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Hypochlorous Acid ◽  
Controlled Trial ◽  
Compression Therapy ◽  
Trial Registration ◽  
Leg Ulcers ◽  
Venous Leg Ulcers ◽  
Exercise Regimen ◽  
Randomised Controlled

IntroductionCompression is the mainstay of treatment for venous leg ulcers (VLUs) and there are few effective adjuvant treatments. There is only observational evidence supporting the use of hypochlorous acid (HOCl) as a topical wound solution on VLU and some limited randomised evidence for the effect of a prescribed regimen of exercise.Methods and analysisThe Factorial4VLU trial is a pragmatic, blinded, factorial randomised controlled trial, with 380 participants receiving either a prescribed exercise regimen compared with usual care and either active HOCl wound solution or placebo wound solution at each dressing change for up to 24 weeks. All participants will receive compression therapy. The primary outcome is the proportion of participants with healed VLU at 12 weeks after randomisation as adjudicated by blinded review of ulcer photographs. Secondary outcomes are proportion healed at 24 weeks, time to healing, estimated change in ulcer area, change in 2-Minute Walk Test, change in health-related quality of life, incidence of infection and incidence of all-cause adverse events. If either of the interventions shows a statistically significant positive difference on healing outcomes, cost-effectiveness will be modelled using a health service perspective.Ethics and disseminationThe Factorial4VLU trial received ethical approval from the Northern B Health and Disability Ethics Committee. We plan to publish the results within 1 year of trial completion and will include the results on the trial registration page.Trial registration numbersAustralia and New Zealand Clinical Trials Register (http://www.anzctr.org.au) (ACTRN12620000116921); Universal Trial Number (WHO) (U1111-1236-2997).

scholarly journals Meeting unmet needs following minor stroke: the SUN randomised controlled trial protocol

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Emma Finch ◽  
Michele Foster ◽  
Tegan Cruwys ◽  
Jennifer Fleming ◽  
Philip Aitken ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Return To Work ◽  
Usual Care ◽  
Hospital Discharge ◽  
Unmet Needs ◽  
Controlled Trial ◽  
Trial Registration ◽  
Minor Stroke ◽  
Secondary Outcome ◽  
Randomised Controlled

Abstract Background Whilst there are comprehensive guidelines for the rehabilitation of people with severe impairments from stroke, there has been less attention on the health and rehabilitation needs of people with minor stroke. Our study will assess whether a new multi-component service pathway using an integrated model based around primary care will reduce unmet need following minor stroke compared with usual care 1 and 3 months post-hospital discharge. Methods One hundred ten patients with minor stroke will be recruited within a parallel, randomised controlled trial design comparing a new service pathway and usual care. The new service pathway will comprise a self-management kit, customised General Practitioner checklist, and a series of minor stroke educational topics. Participants will complete assessments pre-hospital discharge and 1 and 3 months later. The primary outcome measure will be the Survey of Unmet Needs and Service Usage. Secondary outcome measures will include assessments of ability, adjustment and participation; social group connectedness; return to work; health-related quality of life; and perceptions of the new service pathway (intervention group only). Mixed model repeated measures will be used to analyse within and between group differences at each time point. Return to work will be analysed using Chi square tests. Perceptions of the new service pathway will be analysed qualitatively. Dissemination of results The project will produce an evidence-based, multicomponent service pathway for minor stroke patients, applicable to other health services nationally and internationally. Dissemination will include publications and presentations. Trial registration Prospectively registered - Australian New Zealand Clinical Trials Registry (ACTRN12619000133134p) 30 January 2019.

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.

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