scholarly journals Acceptability and Feasibility of a Trial Testing Allocation to Sunscreen and a Smartphone App for Sun Protection: Discontinued Randomized Controlled Trial

2018 ◽  
Vol 1 (1) ◽  
pp. e1 ◽  
Author(s):  
Angela M Rodrigues ◽  
Falko F Sniehotta ◽  
Mark A Birch-Machin ◽  
Patrick Olivier ◽  
Vera Araújo-Soares
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Sun Protection ◽  
Smartphone App ◽  
Randomized Controlled ◽  
Trial Testing

scholarly journals Acceptability and Feasibility of a Trial Testing Allocation to Sunscreen and a Smartphone App for Sun Protection: Discontinued Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Angela M Rodrigues ◽  
Falko F Sniehotta ◽  
Mark A Birch-Machin ◽  
Patrick Olivier ◽  
Vera Ara�jo-Soares
Keyword(s):  
Randomized Controlled Trial ◽  
Pilot Study ◽  
Controlled Trial ◽  
Sun Protection ◽  
Smartphone App ◽  
Random Allocation ◽  
Definitive Trial ◽  
Internal Pilot ◽  
Randomized Controlled ◽  
Internal Pilot Study

BACKGROUND Recreational sun exposure has been associated with melanoma prevalence, and tourism settings are of particular interest for skin cancer prevention. Effective, affordable, and geographically flexible interventions to promote sun protection are needed. OBJECTIVE The aim of this study was to describe the protocol for a definitive randomized controlled trial (RCT) evaluating a smartphone mobile intervention (mISkin app) promoting sun protection in holidaymakers and to assess the acceptability and feasibility of the mISkin app and associated trial procedures in an internal pilot study. METHODS Participants were recruited from the general community. Holidaymakers traveling abroad and owning a smartphone were enrolled in the internal pilot of a 2 (mISkin vs control) x 2 (sun protection factor [SPF] 15 vs SPF 30) RCT with a postholiday follow-up. The smartphone app is fully automated and entails a behavioral intervention to promote sun protection. It consisted of five components: skin assessment, educational videos, ultraviolet (UV) photos, gamification, and prompts for sun protection. Participants were also randomly allocated to receive sunscreen SPF 15 or SPF 30. Primary outcomes for the internal pilot study were acceptability and feasibility of trial procedures and intervention features. Secondary outcomes were collected at baseline and after holidays through face-to-face-assessments and included skin sun damage, sunscreen use (residual weight and application events), and sun protection practices (Web-based questionnaire). RESULTS From 142 registers of interest, 42 participants were randomized (76% [32/42] female; mean age 35.5 years). Outcome assessments were completed by all participants. Random allocation to SPF 15 versus SPF 30 was found not to be feasible in a definitive trial protocol. Of the 21 people allocated to the mISkin intervention, 19 (91%) installed the mISkin on their phones, and 18 (86%) used it at least once. Participants were satisfied with the mISkin app and made suggestions for further improvements. Due to difficulties with the random allocation to SPF and slow uptake, the trial was discontinued. CONCLUSIONS The internal pilot study concluded that randomization to SPF was not feasible and that recruitment rate was slower than expected because of difficulties with gatekeeper engagement. Possible solutions to the problems identified are discussed. Further refinements to the mISkin app are needed before a definitive trial. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN63943558; http://www.isrctn.com/ISRCTN63943558 (Archived by WebCite at http://www.webcitation.org/6xOLvbab8)

scholarly journals A randomized controlled trial testing a virtual perspective-taking intervention to reduce race and socioeconomic status disparities in pain care

Pain ◽  
2019 ◽  
Vol 160 (10) ◽  
pp. 2229-2240 ◽  
Author(s):  
Adam T. Hirsh ◽  
Megan M. Miller ◽  
Nicole A. Hollingshead ◽  
Tracy Anastas ◽  
Stephanie T. Carnell ◽  
...  
Keyword(s):  
Socioeconomic Status ◽  
Randomized Controlled Trial ◽  
Perspective Taking ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Trial Testing ◽  
Pain Care

scholarly journals Developing a Theory-Informed Smartphone App for Early Psychosis: Learning Points From a Multidisciplinary Collaboration

2020 ◽  
Vol 11 ◽  
Author(s):  
Natalie Berry ◽  
Matthew Machin ◽  
John Ainsworth ◽  
Katherine Berry ◽  
Dawn Edge ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Reference Group ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Smartphone App ◽  
Proof Of Concept ◽  
Randomized Controlled ◽  
Multidisciplinary Working ◽  
Software Engineers ◽  
Learning Points

Background: Actissist is a smartphone app designed to deliver an intervention grounded in cognitive behavior therapy for early psychosis. Actissist was developed by a multidisciplinary team of academics, clinicians, experts by experience and software engineers. Actissist has been tested in two trials, the first a proof-of-concept trial where Actissist was safe, acceptable and feasible, the second, a powered randomized controlled trial.Objective: This article describes how our multidisciplinary team designed and developed Actissist. This article describes: (i) how Actissist was informed by initial qualitative interviews and focus groups and an expert reference group; (ii) refinements made to the app based on ongoing user feedback; (iii) successes and challenges encountered; and (iv) learning points and recommendations for involving stakeholders in digital health interventions.Methods: Expert reference group meetings informed the development of Actissist and design of subsequent trials, which included individuals with lived experience of psychosis, clinicians, academics, computer scientists and software engineers. Person-centered stakeholder involvement was promoted using focus groups and qualitative interviews prior to the development of the app, which informed version one of Actissist. Interviews were carried out with participants who had used Actissist. Two further versions of Actissist were developed following additional rounds of testing.Results: Multidisciplinary working throughout the Actissist project led to the development, inclusion and improvement of the app design and content. These changes and features included non-directive and compassionate content, co-designed recovery videos, relaxation exercises, psychoeducation material, ability to “favorite” areas of the app that users found helpful, and goal-setting. Challenges to collaborative working included discrepancies between what stakeholders want and what is technically possible to deliver, resource pressures, trying to deliver desired features within the boundaries of fundamental trial design considerations, and power imbalances associated with multidisciplinary working.Conclusions: The involvement of stakeholders in the design and development and delivery of Actissist has been fundamental to our development approach. Through this collaborative process, we have identified different perspectives and ideas that would have not been generated by the research team alone.Clinical Trial Registrations: Proof-of-concept trial: http://www.isrctn.com/ISRCTN34966555Fully-powered randomized controlled trial: https://www.isrctn.com/ISRCTN76986679

Sign in / Sign up

Export Citation Format

Share Document