scholarly journals Acceptability and feasibility pilot randomised controlled trial of medical skin camouflage for recovery of women prisoners with self-harm scarring (COVER): the study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e021891
Author(s):  
Heather Mitchell ◽  
Kathryn M Abel ◽  
Brendan James Dunlop ◽  
Tammi Walker ◽  
Sandeep Ranote ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Self Esteem ◽  
Health Concern ◽  
Women Prisoners ◽  
Pilot Randomised Controlled Trial ◽  
North East ◽  
Self Harm ◽  
Randomised Controlled

IntroductionSelf-harm in prison is a major public health concern. Less than 5% of UK prisoners are women, but they carry out more than a fifth of prison self-harm. Scars resulting from self-harm can be traumatising and stigmatising, yet there has been little focus on recovery of women prisoners with self-harm scarring. Medical skin camouflage (MSC) clinics treat individuals with disfiguring skin conditions, with evidence of improved well-being, self-esteem and social interactions. Only one community study has piloted the use of MSC for self-harm scarring.Methods and analysisWe describe an acceptability and feasibility pilot randomised controlled trial; the first to examine MSC for women prisoners who self-harm. We aim to randomise 20–25 women prisoners to a 6-week MSC intervention and 20–25 to a waitlist control (to receive the MSC after the study period). We aim to train at least 6–10 long-term prisoners with personal experience of self-harm to deliver the intervention. Before and after intervention, we will pilot collection of women-centred outcomes, including quality of life, well-being and self-esteem. We will pilot collection of self-harm incidents during the intervention, resources used to manage/treat self-harm and follow-up of women at 12 weeks from baseline. Data on recruitment, retention and dropout will be recorded. We aim for the acceptability of the intervention to prison staff and women prisoners to be explored in qualitative interviews and focus groups.Ethics and disseminationEthical approval for COVER has been granted by the North East–York Research Ethics Committee (REC) for phases 1 and 2 (reference: 16/NE/0030) and West of Scotland REC 3 for phases 3 and 4 (reference: 16/WS/0155). Informed consent will be the primary consideration; it will be made clear that participation will have no effect on life in prison or eligibility for parole. Due to the nature of the study, disclosures of serious self-harm may need to be reported to prison officials. We aim for findings to be disseminated via events at the study prison, presentations at national/international conferences, journal publications, prison governor meetings and university/National Health Service trust communications.Trial registration numberNCT02638974; Pre-results.

scholarly journals EXercise to Prevent frailty and Loss Of independence in insulin treated older people with DiabetEs (EXPLODE): protocol for a feasibility randomised controlled trial (RCT)

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e048932
Author(s):  
Rachel Stocker ◽  
James Shaw ◽  
Guy S Taylor ◽  
Miles D Witham ◽  
Daniel J West
Keyword(s):  
Randomised Controlled Trial ◽  
Resistance Training ◽  
Resistance Exercise ◽  
Physical Function ◽  
Controlled Trial ◽  
Well Being ◽  
Training Programme ◽  
North East ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

IntroductionThere are 3.9 million people in the UK with diabetes. Sarcopenia, increased frailty and loss of independence are often unappreciated complications of diabetes. Resistance exercise shows promise in reducing these complications in older adult diabetes patients. The aim of this feasibility randomised controlled trial is to (1) characterise the physical function, cardiovascular health and the health and well-being of older adults with mild frailty with/without diabetes treated with insulin, (2) to understand the feasibility and acceptability of a 4-week resistance exercise training programme in improving these parameters for those with diabetes and (3) to test the feasibility of recruiting and randomising the diabetic participant group to a trial of resistance training.Methods and analysisThirty adults aged ≥60 years with insulin-treated diabetes mellitus (type 1 or 2), and 30 without, all with mild frailty (3–4 on the Rockwood Frailty Scale) will be recruited. All will complete blood, cardiovascular and physical function testing. Only the diabetic group will then proceed into the trial itself. They will be randomised 1:1 to a 4-week semisupervised resistance training programme, designed to increase muscle mass and strength, or to usual care, defined as their regular physical activity, for 4 weeks. This group will then repeat testing. Primary outcomes include recruitment rate, attrition rate, intervention fidelity and acceptability, and adherence to the training programme. A subset of participants will be interviewed before and after the training programme to understand experiences of resistance training, impact on health and living with diabetes (where relevant) as they have aged. Analyses will include descriptive statistics and qualitative thematic analysis.Ethics and disseminationThe North East-Newcastle and North Tyneside 2 Research Ethics Committee (20/NE/0178) approved the study. Outputs will include feasibility data to support funding applications for a future definitive trial, conference and patient and public involvement presentations, and peer-reviewed publications.Trial registration numberISRCTN13193281.

scholarly journals Messages from Manchester: pilot randomised controlled trial following self-harm

2013 ◽  
Vol 203 (1) ◽  
pp. 73-74 ◽  
Author(s):  
Navneet Kapur ◽  
David Gunnell ◽  
Keith Hawton ◽  
Sarmad Nadeem ◽  
Samer Khalil ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Repetition Rate ◽  
Controlled Trial ◽  
Information Leaflet ◽  
Pilot Randomised Controlled Trial ◽  
Usual Treatment ◽  
Self Harm ◽  
Telephone Calls ◽  
Randomised Controlled

SummaryStudies of therapeutic contact following self-harm have had mixed results. We carried out a pilot randomised controlled trial comparing an intervention (information leaflet listing sources of help, two telephone calls soon after presentation and a series of letters over 12 months) to usual treatment alone in 66 adults presenting with self-harm to two hospitals. We found that our methodology was feasible, recruitment was challenging and repeat self-harm was more common in those who received the intervention (12-month repetition rate 34.4% v. 12.5%).

Sign in / Sign up

Export Citation Format

Share Document