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

Proof-of-concept randomized controlled trial of pregnenolone in schizophrenia

2014 ◽  
Vol 231 (17) ◽  
pp. 3647-3662 ◽  
Author(s):  
Christine E. Marx ◽  
Jimmy Lee ◽  
Mythily Subramaniam ◽  
Attilio Rapisarda ◽  
Dianne C. T. Bautista ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Proof Of Concept ◽  
Randomized Controlled

Adding a smartphone app to internet-based self-help for social anxiety: A randomized controlled trial

2018 ◽  
Vol 87 ◽  
pp. 98-108 ◽  
Author(s):  
Johanna Boettcher ◽  
Kristoffer Magnusson ◽  
Arvid Marklund ◽  
Ellinor Berglund ◽  
Rikard Blomdahl ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Social Anxiety ◽  
Controlled Trial ◽  
Smartphone App ◽  
Randomized Controlled ◽  
Self Help

scholarly journals A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis: a randomized controlled trial protocol

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Pablo Rodríguez-Sánchez-Laulhé ◽  
Luis Gabriel Luque-Romero ◽  
Jesús Blanquero ◽  
Alejandro Suero-Pineda ◽  
Ángela Biscarri-Carbonero ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Self Management ◽  
Pinch Strength ◽  
Smartphone App ◽  
Therapeutic Exercise ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background Therapeutic exercise is a safe and cost-effective approach to alleviate hand rheumatoid arthritis (RA)-related symptoms. This study aims to investigate the differences in self-management between a smartphone app (CareHand), using hand exercises and educational advices, compared with a standard approach, on hand overall function, pain intensity, stiffness, and grip and pinch strength in patients with hand RA. Methods The project is a prospective, longitudinal, superiority, randomized controlled trial. Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment). Control intervention involves a paper sheet with exercises and recommendations, and the experimental group includes the use of a smartphone app, which provides individualized exercise programs, self-management, and educational strategies to promote adherence to treatment. Both intervention protocols will last for 3 months. The principal investigator will conduct an educational session at baseline for all participants. Primary outcome comprises the overall hand function, assessed with the Michigan Hand Outcome Questionnaire (MHQ). Secondary outcomes include self-reported functional ability with the Quick DASH questionnaire, self-reported pain intensity and morning stiffness using a Visual Analogue Scale (VAS), and hand grip and pinch strength (dynamometer). Outcome measures will be collected at baseline, and at 1 month and 3-month follow-up. Discussion This study will evaluate the effectiveness of a tele-rehabilitation tool, which uses exercise and self-management strategies, compared to a conventional approach, in patients with hand RA. The smartphone app will allow to monitor the patient’s status and to enhance patient-therapist communication. Some limitations may be related to the short follow-up duration and the lack of evaluation of psychosocial factors. Overall, this new way of promoting long-term effects in patients with a chronic rheumatic disease could be feasible and easy to implement in daily life clinical practice and current musculoskeletal care. Trial registration ClinicalTrials.gov NCT04263974. Registered on 7 March 2020. Date of last update 15 April 2020. Ethics committee code: PI_RH_2018.

A Proof-of-Concept, Randomized, Controlled Trial of Omalizumab in Patients With Severe, Difficult-to-Control, Nonatopic Asthma

CHEST Journal ◽  
2013 ◽  
Vol 144 (2) ◽  
pp. 411-419 ◽  
Author(s):  
Gilles Garcia ◽  
Antoine Magnan ◽  
Raphaël Chiron ◽  
Cécile Contin-Bordes ◽  
Patrick Berger ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Proof Of Concept ◽  
Randomized Controlled

scholarly journals A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis. A randomized controlled trial protocol.

2020 ◽  
Author(s):  
Pablo for the Management of Health Research of Seville F Rodríguez-Sánchez-Laulhé ◽  
Luis Gabriel Luque-Romero ◽  
Jesús Blanquero ◽  
Alejandro Suero-Pineda ◽  
Ángela Biscarri-Carbonero ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Self Management ◽  
Pinch Strength ◽  
Smartphone App ◽  
Therapeutic Exercise ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Therapeutic exercise is a safe and cost-effective approach to alleviate hand rheumatoid arthritis (RA) related symptoms. This study aims to investigate the differences in self-management between a smartphone app (CareHand), using hand exercises and educational advices, compared with a standard approach, on hand overall function, pain intensity, stiffness, and grip and pinch strength in patients with hand RA. Methods: The project is a prospective, longitudinal, superiority, randomized controlled trial. Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment). Control intervention involves a paper sheet with exercises and recommendations, and the experimental group includes the use of a smartphone app, which provides individualized exercise programmes, self-management and educational strategies to promote adherence to treatment. Both intervention protocols will last for 3 months. The principal investigator will conduct an educational session at baseline for all participants. Primary outcome comprises the overall hand function, assessed with the Michigan Hand Outcome Questionnaire (MHQ). Secondary outcomes include self-reported functional ability with the Quick DASH questionnaire, self-reported pain intensity and morning stiffness using a Visual Analogue Scale (VAS), and hand grip and pinch strength (dynamometer). Outcome measures will be collected at baseline, and at 1 month and 3-month follow-up. Discussion: This study will evaluate the effectiveness of a telerehabilitation tool, which uses exercise and self-management strategies, compared to a conventional approach, in patients with hand RA. The smartphone app will allow to monitor the patient´s status, and to enhance patient-therapist communication. Some limitations may be related to the short follow-up duration and the lack of evaluation of psychosocial factors. Overall, this new way of promoting long-term effects in patients with a chronic rheumatic disease could be feasible and easy to implement in daily life clinical practice and current musculoskeletal care.

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