Randomised controlled trial of the Caring Connections intervention to reduce loneliness and perceived social isolation in persons with spinal cord injuries and disorders: study protocol

Introduction
Perceived social isolation and loneliness are understudied in individuals with spinal cord injuries and disorders (SCI/D). The few existing studies reported that they are common, yet poorly treated, in persons with SCI/D. We developed an intervention called Caring Connections (CC) aimed at reducing loneliness and perceived social isolation in persons with SCI/D. CC is a peer-based, recurrent letter writing programme designed to provide moments of positivity. We will conduct and evaluate a randomised controlled trial (RCT) to assess changes in loneliness and social isolation outcomes between the CC intervention and control conditions in community-dwelling individuals with SCI/D.

Methods and analysis
RCT to compare outcomes of community-dwelling individuals with SCI/D undergoing the CC intervention to an attention control group (receiving informational materials on life domains important to a good quality of life). Eligible participants include adults with chronic SCI/D who have been injured for >1 year. The primary outcome is loneliness, measured using the UCLA (University of California, Los Angeles) 3-item Loneliness Scale. Other outcomes include perceived social isolation and social support. A post-trial process evaluation will assess perceived benefits, negative impacts and satisfaction with the intervention, and areas for improvement. We will test the hypotheses of reduced loneliness and perceived social isolation in the CC intervention arm from baseline to 6 months and will also measure the magnitude of effect (difference between CC arm and attention control arm). We will use generalised linear models for repeated measures. We will assume a one-tailed, α=0.05 level of significance for comparisons. Process outcomes will be analysed using mixed methods, including frequencies for the rating items and thematic analysis for open-ended item responses.

Ethics and dissemination
This study has received Hines Veterans Affairs Institutional Review Board approval (#1673654). Findings will be disseminated widely through healthcare organisations, peer-reviewed publications and conferences.

Trial registration number
NCT05295108

Leggi
Novembre 2022

Interventions to reduce stigma related to contraception and abortion: a scoping review

Objectives
We conducted a scoping review to identify the types, volume and characteristics of available evidence and analyse the gaps in the knowledge base for evaluated interventions to reduce contraception and abortion stigma.

Design
We conducted a search of five electronic databases to identify articles published between January 2000 and January 2022, and explored the websites of relevant organisations and grey literature databases for unpublished and non-commercial reports. Articles were assessed for eligibility, and data were extracted.

Data sources
We searched MEDLINE, PubMed, Embase, Web of Science and PsycINFO.

Eligibility criteria
Articles included were: (1) published between January 2000 and January 2022, (2) written in English, (3) reports of the evaluation of an intervention designed to reduce contraceptive and/or abortion stigma, (4) used any type of study design and (5) conducted in any country context.

Data extraction and synthesis
Included studies were charted according to study location, study aim, study design, type of contraceptive method(s), study population, type of stigma, and intervention approach.

Results
Some 18 articles were included in the final analysis (11 quantitative, 6 qualitative and 1 mixed methods). Fourteen of the studies focused exclusively on abortion stigma, and two studies focused on contraception stigma only; while two studies considered both. A majority of the studies aimed to address intrapersonal stigma. We found no interventions designed to address stigma at the structural level. In terms of intervention approaches, seven were categorised as education/training/skills building, five as counselling/peer support, three as contact and three as media.

Conclusion
There is a dearth of evaluations of interventions to reduce contraception and abortion stigma. Investment in implementation science is necessary to develop the evidence base and inform the development of effective interventions, and use existing stigma scales to evaluate effectiveness. This scoping review can serve as a precursor to systematic reviews assessing the effectiveness of approaches.

Leggi
Novembre 2022

Study protocol of the PROUD48 study comparing the effects of pemafibrate and omega-3 fatty acid ethyl esters on ApoB-48 in statin-treated patients with dyslipidaemia: a prospective, multicentre, open-label, randomised, parallel group trial in Japan

Introduction
This study will compare the lowering effects of pemafibrate and omega-3 fatty acid ethyl esters on fasting apolipoprotein B-48 (apoB-48), a surrogate marker reflecting postprandial hypertriglyceridaemia, which is a residual risk for atherosclerotic cardiovascular disease with statin treatment.

Methods and analysis
This is a prospective, multicentre, open-label, randomised, parallel group, comparative trial. Adult Japanese patients with dyslipidaemia receiving statin treatment for more than 4 weeks with a fasting triglyceride level ≥177 mg/dL will be randomly assigned in a 1:1 ratio to receive pemafibrate (0.4 mg orally per day) or omega-3 fatty acid ethyl esters (4 g orally per day) for 16 weeks. The primary endpoint is the percentage change in fasting apoB-48 from baseline to 16 weeks. The key secondary endpoints include the change in fasting apoB-48 from baseline to 16 weeks, the percentage changes in clinical variables from baseline to 16 weeks and the incidence of adverse events. A total sample size of 128 was set by considering the increased drop-out rate due to the COVID-19 pandemic, in addition to estimation based on a two-sided alpha of 0.05 and a power of 0.8 for apoB-48.

Ethics and dissemination
The study protocol has been approved by the Certified Review Board of the University of the Ryukyus for Clinical Research Ethics (No. CRB7200001) and will be performed in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all participants. The results of the study will be disseminated through publications and conference presentations to participants, healthcare professionals and the public.

Trial registration number
jRCTs071200011.

Leggi
Novembre 2022