scholarly journals A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial

10.2196/10360 ◽  
2018 ◽  
Vol 7 (11) ◽  
pp. e10360 ◽  
Author(s):  
Robert D Furberg ◽  
Melissa Raspa ◽  
Anne C Wheeler ◽  
Lauren A McCormack ◽  
Donald B Bailey
Keyword(s):  
Randomized Controlled Trial ◽  
Informed Consent ◽  
Digital Health ◽  
Controlled Trial ◽  
Decisional Capacity ◽  
Randomized Controlled

scholarly journals A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Robert D Furberg ◽  
Melissa Raspa ◽  
Anne C Wheeler ◽  
Lauren A McCormack ◽  
Donald B Bailey
Keyword(s):  
Decision Making ◽  
Randomized Controlled Trial ◽  
Decision Aid ◽  
Digital Health ◽  
Controlled Trial ◽  
The United States ◽  
Informed Decision ◽  
Consent Process ◽  
Decisional Capacity ◽  
Randomized Controlled

BACKGROUND Any study with human subjects must have a robust consent process to ensure that participants understand the study and can decide whether they want to be involved. Investigators must determine whether a potential study participant is able to make an informed decision and what modifications or supports are needed to maximize participation in decision making. A variety of approaches have been used to modify consent forms and the consent process to increase the research participants’ decisional capacity. This protocol describes a randomized controlled trial (RCT) of a digital health app to support decision making among individuals contemplating providing consent to participate in a clinical trial. OBJECTIVE The objective of this RCT will be to determine if the use of a tablet-based app facilitates greater participation in and satisfaction with the consent process compared with standard practice and identify which individual factors are associated with better response to the decision aid. We hypothesize that the tablet-based version of the consent process will promote more informed decision making, including decisions that are more consistent with individual preferences and values expressed during qualitative data collection. METHODS A two-arm RCT will be conducted in a sample of approximately 100 individuals with fragile X syndrome in their homes across the United States. RESULTS Data analysis will be completed by late 2018. CONCLUSIONS By developing and testing a novel consent decision aid, we will have a better understanding of whether and how technological support can optimize the fit between the decisional capacity and the decisional process. CLINICALTRIAL ClinicalTrials.gov NCT02465931; https://clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/72Q3xJQAw) INTERNATIONAL REGISTERED REPOR PRR1-10.2196/10360

scholarly journals Research and Implementation Lessons Learned From a Youth-Targeted Digital Health Randomized Controlled Trial (the ARMADILLO Study)

10.2196/13005 ◽  
2019 ◽  
Vol 7 (8) ◽  
pp. e13005
Author(s):  
Lianne Gonsalves ◽  
Winnie Wangari Njeri ◽  
Megan Schroeder ◽  
Jefferson Mwaisaka ◽  
Peter Gichangi
Keyword(s):  
Randomized Controlled Trial ◽  
Digital Health ◽  
Controlled Trial ◽  
Text Message ◽  
Health Interventions ◽  
World Health ◽  
Intervention Period ◽  
Implementation Challenges ◽  
Randomized Controlled ◽  
Client Side

Background Evidence is lacking on the efficacy of sexual and reproductive health (SRH) communication interventions for youth (aged 15-24 years), especially from low- and middle-income countries. Therefore, the World Health Organization initiated the Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes (ARMADILLO) program, a free, menu-based, on-demand text message (SMS, short message service) platform providing validated SRH content developed in collaboration with young people. A randomized controlled trial (RCT) assessing the effect of the ARMADILLO intervention on SRH-related outcomes was implemented in Kwale County, Kenya. Objective This paper describes the implementation challenges related to the RCT, observed during enrollment and the intervention period, and their implications for digital health researchers and program implementers. Methods This was an open, three-armed RCT. Following completion of a baseline survey, participants were randomized into the ARMADILLO intervention (arm 1), a once-a-week contact SMS text message (arm 2), or usual care (arm 3, no intervention). The intervention period lasted seven weeks, after which participants completed an endline survey. Results Two study team decisions had significant implications for the success of the trial’s enrollment and intervention implementation: a hands-off participant recruitment process and a design flaw in an initial language selection menu. As a result, three weeks after recruitment began, 660 participants had been randomized; however, 107 (53%) participants in arm 1 and 136 (62%) in arm 2 were “stuck” at the language menu. The research team called 231 of these nonengaging participants and successfully reached 136 to learn reasons for nonengagement. Thirty-two phone numbers were found to be either not linked to our participants (a wrong number) or not in their primary possession (a shared phone). Among eligible participants, 30 participants indicated that they had assumed the introductory message was a scam or spam. Twenty-seven participants were confused by some aspect of the system. Eleven were apathetic about engaging. Twenty-four nonengagers experienced some sort of technical issue. All participants eventually started their seven-week study period. Conclusions The ARMADILLO study’s implementation challenges provide several lessons related to both researching and implementing client-side digital health interventions, including (1) have meticulous phone data collection protocols to reduce wrong numbers, (2) train participants on the digital intervention in efficacy assessments, and (3) recognize that client-side digital health interventions have analog discontinuation challenges. Implementation lessons were (1) determine whether an intervention requires phone ownership or phone access, (2) digital health campaigns need to establish a credible presence in a busy digital space, and (3) interest in a service can be sporadic or fleeting. Clinical Trial International Standard Randomized Controlled Trial Number (ISRCTN): 85156148; http://www.isrctn. com/ISRCTN85156148

scholarly journals A randomized controlled trial comparing video-assisted informed consent with standard consent for Mohs micrographic surgery

2020 ◽  
Vol 1 (1) ◽  
pp. 13-20
Author(s):  
Yueyue Miao ◽  
Victoria L. Venning ◽  
Kylie-Ann Mallitt ◽  
Julia E.J. Rhodes ◽  
Noah J. Isserman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Informed Consent ◽  
Controlled Trial ◽  
Mohs Micrographic Surgery ◽  
Micrographic Surgery ◽  
Randomized Controlled ◽  
Video Assisted

Randomized, Controlled Trial of an Easy-to-Read Informed Consent Statement for Clinical Trial Participation: A Study of the Eastern Cooperative Oncology Group

2003 ◽  
Vol 21 (5) ◽  
pp. 836-842 ◽  
Author(s):  
Cathy A. Coyne ◽  
Ronghui Xu ◽  
Peter Raich ◽  
Kathy Plomer ◽  
Mark Dignan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Informed Consent ◽  
Controlled Trial ◽  
Eastern Cooperative Oncology Group ◽  
Trial Participation ◽  
Patient Anxiety ◽  
Randomized Controlled ◽  
Patient Comprehension ◽  
Study Results

Purpose: Studies have documented that the majority of consent documents for medical diagnosis and treatment are written at a reading level above that of the majority of the U.S. population. This study hypothesized that use of an easy-to-read consent statement, when compared with a standard consent statement, will result in higher patient comprehension of the clinical treatment protocol, lower patient anxiety, higher patient satisfaction, and higher patient accrual. Methods: A randomized controlled trial was conducted in 44 institutions that were members or affiliates of three cooperative oncology groups. Institutions were randomly assigned to administer either an easy-to-read consent statement or the standard consent statement to patients being recruited to participate in selected cancer treatment trials. Telephone interviews were conducted with a total of 207 patients to assess study outcomes. Results: Patients in the intervention arm demonstrated significantly lower consent anxiety and higher satisfaction compared with patients in the control arm. Patient comprehension and state anxiety were not affected by the intervention. Accrual rates into the parent studies also did not differ significantly between the two study groups. Conclusion: Clinical trial informed consent statements can be modified to be easier to read without omitting critical information. Patient anxiety and satisfaction can be affected by the consent document. The generalizability of these study results is limited by the characteristics of the patient sample. Ninety percent of the sample were white women, and the mean Rapid Estimate of Adult Literacy in Medicine score was approximately 64, indicating a literacy level at or above the ninth grade.

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