scholarly journals SUpporting wellbeing through PEeR-Befriending (SUPERB) feasibility trial: fidelity of peer-befriending for people with aphasia

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e047994
Author(s):  
Nicholas Behn ◽  
Becky Moss ◽  
Sally McVicker ◽  
Abi Roper ◽  
Sarah Northcott ◽  
...  
Keyword(s):  
Usual Care ◽  
Controlled Trial ◽  
Median Number ◽  
Feasibility Trial ◽  
Intrarater Reliability ◽  
Training And Supervision ◽  
Registration Number ◽  
Agreement Coefficient ◽  
Low Levels ◽  
Randomised Controlled

ObjectiveTo evaluate systematically the fidelity of a peer-befriending intervention for people with aphasia.DesignSUpporting wellbeing through Peer-befriending (SUPERB) was a feasibility randomised controlled trial comparing usual care to usual care +peer-befriending. This paper reports on the fidelity of all intervention aspects (training and supervision of providers/befrienders; intervention visits) which was evaluated across all areas of the Behaviour Change Consortium framework.SettingCommunity.ParticipantsPeople with aphasia early poststroke and low levels of distress, randomised to the intervention arm of the trial (n=28); 10 peer-befrienders at least 1-year poststroke.InterventionPeer-befrienders were trained (4–6 hours); and received regular supervision (monthly group while actively befriending, and one-to-one as and when needed) in order to provide six 1-hour peer-befriending visits over 3 months.Main measuresMetrics included number and length of training, supervision sessions and visits. All training and supervision sessions and one (of six) visits per pair were rated against fidelity checklists and evaluated for inter-rater and intrarater reliability (Gwets AC1 agreement coefficient). Per-cent adherence to protocol was evaluated.ResultsAll peer-befrienders received 4–6 hours training over 2–3 days as intended. There were 25 group supervision sessions with a median number attended of 14 (IQR=8–18). Twenty-six participants agreed (92.8%) to the intervention and 21 (80.8%) received all six visits (median visit length 60 min). Adherence was high for training (91.7%–100%) and supervision (83%–100%) and moderate-to-high for befriending visits (66.7%–100%). Where calculable, inter-rater and intrarater reliability was high for training and supervision (Gwets AC1 >0.90) and moderate-to-high for intervention visits (Gwets AC1 0.44–1.0).ConclusionPlanning of fidelity processes at the outset of the trial and monitoring throughout was feasible and ensured good-to-high fidelity for this peer-befriending intervention. The results permit confidence in other findings from the SUPERB trial.Trial registration numberNCT02947776.

scholarly journals A feasibility, randomised controlled trial of a complex breathlessness intervention in idiopathic pulmonary fibrosis (BREEZE-IPF): study protocol

2019 ◽  
Vol 5 (4) ◽  
pp. 00186-2019 ◽  
Author(s):  
Caroline Wright ◽  
Simon P. Hart ◽  
Victoria Allgar ◽  
Anne English ◽  
Flavia Swan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Usual Care ◽  
Study Protocol ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Randomised Controlled

IntroductionIdiopathic pulmonary fibrosis (IPF) is a chronic and progressive lung disease that causes breathlessness and cough that worsen over time, limiting daily activities and negatively impacting quality of life. Although treatments are now available that slow the rate of lung function decline, trials of these treatments have failed to show improvement in symptoms or quality of life. There is an immediate unmet need for evidenced-based interventions that improve patients' symptom burden and make a difference to everyday living. This study aims to assess the feasibility of conducting a definitive randomised controlled trial of a holistic, complex breathlessness intervention in people with IPF.Methods and analysisThe trial is a two-centre, randomised controlled feasibility trial of a complex breathlessness intervention compared with usual care in patients with IPF. 50 participants will be recruited from secondary care IPF clinics and randomised 1:1 to either start the intervention within 1 week of randomisation (fast-track group) or to receive usual care for 8 weeks before receiving the intervention (wait-list group). Participants will remain in the study for a total of 16 weeks. Outcome measures will be feasibility outcomes, including recruitment, retention, acceptability and fidelity of the intervention. Clinical outcomes will be measured to inform outcome selection and sample size calculation for a definitive trial.Ethics and disseminationYorkshire and The Humber – Bradford Leeds Research Ethics Committee approved the study protocol (REC 18/YH/0147). Results of the main trial and all secondary end-points will be submitted for publication in a peer-reviewed journal.

scholarly journals FACT: a randomised controlled trial to assess the feasibility of QbTest in the assessment process of attention deficit hyperactivity disorder (ADHD) for young people in prison—a feasibility trial protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e035519
Author(s):  
Charlotte Lennox ◽  
Charlotte Lucy Hall ◽  
Lesley-Anne Carter ◽  
Bryony Beresford ◽  
Susan Young ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Randomised Controlled Trial ◽  
Young People ◽  
Usual Care ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Assessment Process ◽  
Feasibility Trial ◽  
Hyperactivity Disorder ◽  
Randomised Controlled

IntroductionThe prevalence of attention deficit hyperactivity disorder (ADHD) within the Children and Young People Secure Estate (CYPSE) is much higher than seen in the general population. To make a diagnosis of ADHD, clinicians draw on information from multiple sources, including parents and teachers. However, obtaining these is particularly difficult for young people in the secure estate. There is increasing evidence in the community that QbTest is able to assist in the accurate and earlier diagnosis of ADHD. The objective of this study is to assess the feasibility and acceptability of QbTest in the assessment of ADHD within the CYPSE.Methods and analysisA single-centre parallel group feasibility randomised controlled trial will be conducted. Sixty young people within the CYPSE identified as displaying possible symptoms of ADHD will be randomised to the intervention arm (n=30; QbTest plus usual care) or control arm (n=30; usual care). Primary analyses will be descriptive and a process evaluation will be conducted to assess the contexts involved in implementing the intervention. Interviews will be conducted to explore acceptability and thematic analysis will be used to analyse the data.Ethics and disseminationThis study was approved by National Health Service Wales research ethics committee 3 (18/WA/0347) on 15 February 2019. The findings will be published in peer-reviewed journals, presented at relevant conferences and disseminated to the public via summaries cocreated with our patient and public involvement group.Trial registration numberISRCTN17402196

scholarly journals A feasibility randomised controlled trial of extended brief intervention for alcohol misuse in adults with mild to moderate intellectual disabilities living in the community

2017 ◽  
Vol 41 (S1) ◽  
pp. S475-S475
Author(s):  
C. Kouimtsidis ◽  
A. Hassiotis ◽  
K. Scior ◽  
G. Baio ◽  
R. Hunter
Keyword(s):  
Usual Care ◽  
Alcohol Misuse ◽  
Controlled Trial ◽  
Unit Cost ◽  
Alcohol Problems ◽  
Feasibility Trial ◽  
Control Group ◽  
Harmful Drinking ◽  
Competing Interest ◽  
Randomised Controlled

IntroductionExtended brief interventions (EBIs) are effective in targeting alcohol misuse in the general population. However, little is known on the effects of EBI in adults with intellectual (also known as learning disabilities).ObjectivesIn this feasibility trial we compared EBI with usual care for alcohol misuse in adults with mild to moderate intellectual disability (ID).MethodsThe study took place in three community ID services in England. Participants aged 18–65 years with reported alcohol problems, a score > 8 on the alcohol use disorder identification test (AUDIT), and IQ < 70 (+/5% CI) were recruited and were randomly allocated to either EBI (5 weekly sessions and 1 follow-up at 8 weeks) and usual care or usual care alone. Research assessments took place at baseline, two and three months.ResultsThirty individuals were randomised (15 in each arm). In regard to harmful drinking, at baseline, all the participants exceeded the relevant threshold. At 8 weeks, the proportion of participants with harmful drinking decreased to 60% for both groups, at 12 weeks it was decreased by 66.7% and 46.7% for the intervention and the control group respectively. The unit cost for the delivery of EBI is £ 430.ConclusionsRecruitment to this trial has been proven challenging as prevalence of alcohol misuse in the targeted population was lower than anticipated. EBI may provide an effective low intensity treatment for this population. Participants’ and carers’ feedback on their experience was overall positive.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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 Using an internet intervention to support self-management of low back pain in primary care: findings from a randomised controlled feasibility trial (SupportBack)

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e016768 ◽  
Author(s):  
Adam W A Geraghty ◽  
Rosie Stanford ◽  
Beth Stuart ◽  
Paul Little ◽  
Lisa C Roberts ◽  
...  
Keyword(s):  
Primary Care ◽  
Usual Care ◽  
Controlled Trial ◽  
Internet Intervention ◽  
Feasibility Trial ◽  
Low Back ◽  
Telephone Support ◽  
Primary Care Patients ◽  
Randomised Controlled

ObjectiveTo determine the feasibility of a randomised controlled trial of an internet intervention for low back pain (LBP) using three arms: (1) usual care, (2) usual care plus an internet intervention or (3) usual care plus an internet intervention with additional physiotherapist telephone support.Design and settingA three-armed randomised controlled feasibility trial conducted in 12 general practices in England.ParticipantsPrimary care patients aged over 18 years, with current LBP, access to the internet and without indicators of serious spinal pathology or systemic illness.InterventionsThe ‘SupportBack’ internet intervention delivers a 6-week, tailored programme, focused on graded goal setting, self-monitoring and provision of tailored feedback to encourage physical activity. Additional physiotherapist telephone support consisted of three brief telephone calls over a 4-week period, to address any concerns and provide reassurance.OutcomesThe primary outcomes were the feasibility of the trial design including recruitment, adherence and retention at follow-up. Secondary descriptive and exploratory analyses were conducted on clinical outcomes including LBP-related disability at 3 months follow-up.ResultsPrimary outcomes: 87 patients with LBP were recruited (target 60–90) over 6 months, and there were 3 withdrawals. Adherence to the intervention was higher in the physiotherapist-supported arm, compared with the stand-alone internet intervention. Trial physiotherapists adhered to the support protocol. Overall follow-up rate on key clinical outcomes at 3 months follow-up was 84%.ConclusionsThis study demonstrated the feasibility of a future definitive randomised controlled trial to determine the clinical and cost-effectiveness of the SupportBack intervention in primary care patients with LBP.Trial registration numberISRCTN31034004; Results.

scholarly journals Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial

2019 ◽  
Author(s):  
Aisha Shafayat ◽  
Emese Csipke ◽  
Lucy Bradshaw ◽  
Georgina Charlesworth ◽  
Florence Day ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Feasibility Trial ◽  
Self Management ◽  
Mild Dementia ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/Design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at three and six month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at three to six months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so will provide data to inform the design and conduct of a future trial. Trial Registration and protocol version ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019 Keywords Dementia, self-management, feasibility trial

scholarly journals Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial

2019 ◽  
Author(s):  
Aisha Shafayat ◽  
Emese Csipke ◽  
Lucy Bradshaw ◽  
Georgina Charlesworth ◽  
Florence Day ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Feasibility Trial ◽  
Self Management ◽  
Mild Dementia ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/Design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at three and six month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at three to six months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so will provide data to inform the design and conduct of a future trial. Trial Registration and protocol version ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019 Keywords Dementia, self-management, feasibility trial

scholarly journals INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e029185
Author(s):  
Richard Collings ◽  
Jennifer A Freeman ◽  
Jos Latour ◽  
Patricia Jane Vickery ◽  
Sam Glasser ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Diabetic Neuropathy ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Control Group ◽  
Foot Ulceration ◽  
Randomised Controlled

IntroductionFoot ulceration is a multifactorial complication of diabetes. Therapeutic insoles and footwear are frequently used to reduce elevated tissue pressures associated with risk of foot ulceration. A novel protocol using in-shoe pressure measurement technology to provide an instant optimised insole and house shoe solution has been developed, with the aim of reducing foot ulceration.AimThis study aims to assess the feasibility of conducting a multicentre randomised controlled trial to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy.Methods and analysisThis study is a participant and assessor blinded, randomised, multicentre parallel group feasibility trial with embedded qualitative study. Seventy-six participants will be recruited from three podiatry clinics and randomised to an optimised insole plus usual care (intervention group) or standard insole plus usual care (control group) using a minimisation by randomisation procedure by study centre and previous ulcer status. Assessment visits and data collection will be at baseline, 3 months, 6 months and 12 months. Feasibility and acceptability of the trial procedures will be determined in terms of recruitment and retention rates, data completion rates, intervention adherence and effectiveness of the blinding.Assessment of the appropriateness and performance of outcome measures will inform selection of the primary and secondary outcomes and sample size estimate for the anticipated definitive randomised controlled trial. Clinical outcomes include incidence of plantar foot ulceration and change in peak plantar pressure. Twelve participants (four from each centre) and three treating podiatrists (one from each centre) will be interviewed to explore their experiences of receiving and delivering the intervention.Ethics and disseminationThe study was approved by the South-West Exeter Research Ethics Committee. Findings will be disseminated through conference presentations, public platforms and academic publications.Trials registration numberISRCTN16011830; Pre-results.

scholarly journals Randomised controlled trial of a just-in-time adaptive intervention (JITAI) smoking cessation smartphone app: the Quit Sense feasibility trial protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e048204
Author(s):  
Felix Naughton ◽  
Chloë Brown ◽  
Juliet High ◽  
Caitlin Notley ◽  
Cecilia Mascolo ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Just In Time ◽  
Smartphone App ◽  
Potential Cost ◽  
Adaptive Intervention ◽  
Randomised Controlled

IntroductionA lapse (any smoking) early in a smoking cessation attempt is strongly associated with reduced success. A substantial proportion of lapses are due to urges to smoke triggered by situational cues. Currently, no available interventions proactively respond to such cues in real time. Quit Sense is a theory-guided just-in-time adaptive intervention smartphone app that uses a learning tool and smartphone sensing to provide in-the-moment tailored support to help smokers manage cue-induced urges to smoke. The primary aim of this randomised controlled trial (RCT) is to assess the feasibility of delivering a definitive online efficacy trial of Quit Sense.Methods and analysesA two-arm parallel-group RCT allocating smokers willing to make a quit attempt, recruited via online adverts, to usual care (referral to the NHS SmokeFree website) or usual care plus Quit Sense. Randomisation will be stratified by smoking rate (<16 vs ≥16 cigarettes/day) and socioeconomic status (low vs high). Recruitment, enrolment, baseline data collection, allocation and intervention delivery will be automated through the study website. Outcomes will be collected at 6 weeks and 6 months follow-up via the study website or telephone, and during app usage. The study aims to recruit 200 smokers to estimate key feasibility outcomes, the preliminary impact of Quit Sense and potential cost-effectiveness, in addition to gaining insights on user views of the app through qualitative interviews.Ethics and disseminationEthics approval has been granted by the Wales NHS Research Ethics Committee 7 (19/WA/0361). The findings will be disseminated to the public, the funders, relevant practice and policy representatives and other researchers.Trial registration numberISRCTN12326962.

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