Recruiting people with HIV to an online self-management support randomised controlled trial: barriers and facilitators

Sexual Health ◽  
2019 ◽  
Vol 16 (4) ◽  
pp. 340
Author(s):  
Karen M. Klassen ◽  
Tanya Millard ◽  
Julia Stout ◽  
Karalyn McDonald ◽  
Sarity Dodson ◽  
...  

Background Recruitment of people to randomised trials of online interventions presents particular challenges and opportunities. The aim of this study was to evaluate factors associated with the recruitment of people with HIV (PWHIV) and their doctors to the HealthMap trial, a cluster randomised trial of an online self-management program. Methods: Recruitment involved a three-step process. Study sites were recruited, followed by doctors caring for PWHIV at study sites and finally PWHIV. Data were collected from study sites, doctors and patient participants. Factors associated with site enrolment and patient participant recruitment were investigated using regression models. Results: Thirteen study sites, 63 doctor participants and 728 patient participants were recruited to the study. Doctors having a prior relationship with the study investigators (odds ratio (OR) 13.3; 95% confidence interval (CI) 3.0, 58.7; P = 0.001) was positively associated with becoming a HealthMap site. Most patient participants successfully recruited to HealthMap (80%) had heard about the study from their HIV doctor. Patient enrolment was associated with the number of people with HIV receiving care at the site (β coefficient 0.10; 95% CI 0.04, 0.16; P = 0.004), but not with employing a clinic or research nurse to help recruit patients (β coefficient 55.9; 95% CI –2.55, 114.25; P = 0.06). Conclusion: Despite substantial investment in online promotion, a previous relationship with doctors was important for doctor recruitment, and doctors themselves were the most important source of patient recruitment to the HealthMap trial. Clinic-based recruitment strategies remain a critical component of trial recruitment, despite expanding opportunities to engage with online communities.

2018 ◽  
Vol 208 (2) ◽  
pp. 69-74 ◽  
Author(s):  
Richard L Reed ◽  
Leigh Roeger ◽  
Sara Howard ◽  
Jodie M Oliver‐Baxter ◽  
Malcolm W Battersby ◽  
...  

BMJ ◽  
2018 ◽  
pp. k1959 ◽  
Author(s):  
Rosie Dobson ◽  
Robyn Whittaker ◽  
Yannan Jiang ◽  
Ralph Maddison ◽  
Matthew Shepherd ◽  
...  

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e037251
Author(s):  
Lindsay Jibb ◽  
Paul C Nathan ◽  
Vicky Breakey ◽  
Conrad Fernandez ◽  
Donna Johnston ◽  
...  

IntroductionPain negatively affects the health-related quality of life (HRQL) of adolescents with cancer. The Pain Squad+ smartphone-based application (app), has been developed to provide adolescents with real-time pain self-management support. The app uses a validated pain assessment and personalised pain treatment advice with centralised decision support via a registered nurse to enable real-time pain treatment in all settings. The algorithm informing pain treatment advice is evidence-based and expert-vetted. This trial will longitudinally evaluate the impact of Pain Squad+, with or without the addition of nurse support, on adolescent health and cost outcomes.Methods and analysisThis will be a pragmatic, multicentre, waitlist controlled, 3-arm parallel-group superiority randomised trial with 1:1:1 allocation enrolling 74 adolescents with cancer per arm from nine cancer centres. Participants will be 12 to 18 years, English-speaking and with ≥3/10 pain. Exclusion criteria are significant comorbidities, end-of-life status or enrolment in a concurrent pain study. The primary aim is to determine the effect of Pain Squad+, with and without nurse support, on pain intensity in adolescents with cancer, when compared with a waitlist control group. The secondary aims are to determine the immediate and sustained effect over time of using Pain Squad+, with and without nurse support, as per prospective outcome measurements of pain interference, HRQL, pain self-efficacy and cost. Linear mixed models with baseline scores as a covariate will be used. Qualitative interviews with adolescents from all trial arms will be conducted and analysed.Ethics and disseminationThis trial is approved by the Hospital for Sick Children Research Ethics Board. Results will provide data to guide adolescents with cancer and healthcare teams in treating pain. Dissemination will occur through partnerships with stakeholder groups, scientific meetings, publications, mass media releases and consumer detailing.Trial registration numberNCT03632343(ClinicalTrials.gov).


BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e033520 ◽  
Author(s):  
Shilpa Patel ◽  
Felix Achana ◽  
Dawn Carnes ◽  
Sandra Eldridge ◽  
David R Ellard ◽  
...  

IntroductionChronic headaches are poorly diagnosed and managed and can be exacerbated by medication overuse. There is insufficient evidence on the non-pharmacological approaches to helping people living with chronic headaches.Methods and analysisChronic Headache Education and Self-management Study is a pragmatic randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management education support programme on top of usual care for patients with chronic headaches against a control of usual care and relaxation. The intervention is a 2-day group course based on education, personal reflection and a cognitive behavioural approach, plus a nurse-led one-to-one consultation and follow-up over 8 weeks. We aim to recruit 689 participants (356 to the intervention arm and 333 to the control) from primary care and self-referral in London and the Midlands. The trial is powered to show a difference of 2.0 points on the Headache Impact Test, a patient-reported outcome measure at 12 months post randomisation. Secondary outcomes include health related quality of life, self-efficacy, social activation and engagement, anxiety and depression and healthcare utilisation. Outcomes are being measured at 4, 8 and 12 months. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained.Ethics and disseminationThis trial will provide data on effectiveness and cost-effectiveness of a self-management support programme for chronic headaches. The results will inform commissioning of services and clinical practice. North West – Greater Manchester East Research Ethics Committee have approved the trial. The current protocol version is 3.6 date 7 March 2019.Trial registration numberISRCTN79708100.


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