scholarly journals Design and Rationale for the Deep South Interactive Voice Response (IVR) System-Supported Active Lifestyle (DIAL) Study: Protocol for a Randomized Controlled Trial (Preprint)

10.2196/29245 ◽  
2021 ◽  
Author(s):  
Nashira I Brown ◽  
Mary Anne Powell ◽  
Monica Baskin ◽  
Wendy Demark-Wahnefried ◽  
Claudia Hardy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Interactive Voice Response ◽  
Controlled Trial ◽  
Deep South ◽  
Active Lifestyle ◽  
Randomized Controlled ◽  
Voice Response

scholarly journals Design and Rationale for the Deep South Interactive Voice Response (IVR) System-Supported Active Lifestyle (DIAL) Study: Proposal for a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Nashira I Neal ◽  
Mary Anne Powell ◽  
Monica Baskin ◽  
Wendy Demark-Wahnefried ◽  
Claudia Hardy ◽  
...  
Keyword(s):  
Physical Activity ◽  
Physical Activity Intervention ◽  
Interactive Voice Response ◽  
Controlled Trial ◽  
Deep South ◽  
Rural County ◽  
Active Lifestyle ◽  
Randomized Controlled ◽  
Phone Counseling ◽  
Voice Response

BACKGROUND Physical inactivity and related cancer incidence and mortality rates are disproportionately high in the U.S. Deep South, a rural, medically underserved region with a large African American population compared to the rest of the nation. Given this region’s lower rates of literacy and Internet access, Interactive Voice Response (IVR)-automated telephone-based interventions have the potential to help overcome physical activity intervention barriers (literacy, internet access, costs transportation) but have yet to be extended to rural, underserved populations, such as the Deep South. Thus, extensive formative research was conducted to develop, and beta test the Deep South Interactive Voice Response System Supported Active Lifestyle (DIAL) intervention in preparation for dissemination in rural Alabama counties OBJECTIVE To describe the design and rationale of the ongoing efficacy trial of the DIAL intervention. METHODS The 2-arm randomized controlled trial will compare a 12-month physical activity intervention versus a wait-list control condition in 240 underactive adults from 6 rural Alabama counties. The DIAL intervention is based on the Social Cognitive Theory and includes IVR-automated physical activity phone counseling (daily in months 0-3, twice weekly in months 4-6 and weekly in months 7-12) and support from local rural county coordinators with the UAB O’Neal Comprehensive Cancer Center Community Outreach and Engagement Office. The primary outcome is weekly minutes of moderate-to-vigorous intensity physical activity (7-Day PAR, accelerometry) at baseline, 6 months, 12 months, and 18 months. Rural Active Living Assessments will be conducted in each rural county to assess walkability, recreational amenities, and inform future environment/policy efforts. RESULTS Start up activities (hiring/training staff, purchasing supplies) were completed in 2019. Study recruitment and assessments began in September 2020 and are ongoing. CONCLUSIONS IVR-supported phone counseling has great potential for addressing physical activity barriers (e.g., culture, literacy, cost, transportation) and reducing related rural health disparities in this region. CLINICALTRIAL ClinicalTrials.gov NCT03903874

scholarly journals Impact of a mobile phone-based interactive voice response software on tuberculosis treatment outcomes in Uganda (CFL-TB): a protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Dathan Mirembe Byonanebye ◽  
Hope Mackline ◽  
Christine Sekaggya-Wiltshire ◽  
Agnes N. Kiragga ◽  
Mohammed Lamorde ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Outcomes ◽  
Interactive Voice Response ◽  
Controlled Trial ◽  
Treatment Success ◽  
Treatment Completion ◽  
Randomized Controlled ◽  
Tb Treatment ◽  
The Impact ◽  
Voice Response

Abstract Background Throughout the last decade, tuberculosis (TB) treatment success has not surpassed 90%, the global target. The impact of mobile health interventions (MHIs) on TB treatment outcomes is unknown, especially in low- and middle-income countries (LMICs). MHIs, including interactive voice response technology (IVRT), may enhance adherence and retention in the care of patients with tuberculosis and improve TB treatment outcomes. This study seeks to determine the impact of IVRT-based MHI on TB treatment success (treatment completion and cure rates) in patients with TB receiving care at five public health facilities in Uganda. Methods We used a theory-based and human-centered design (HCD) to adapt an already piloted software to design “Call for life-TB” (CFL-TB), an MHI that utilizes IVRT to deliver adherence and appointment reminders and allows remote symptom reporting. This open-label, multicenter, randomized controlled trial (RCT), with nested qualitative and economic evaluation studies, will determine the impact of CFL-TB on TB treatment success in patients with drug-susceptible TB in Uganda. Participants (n = 274) at the five study sites will be randomized (1:1 ratio) to either control (standard of care) or intervention (adherence and appointment reminders, and health tips) arms. Multivariable regression models will be used to compare treatment success, adherence to treatment and clinic appointments, and treatment completion at 6 months post-enrolment. Additionally, we will determine the cost-effectiveness, acceptability, and perceptions of stakeholders. The study received national ethical approval and was conducted in accordance with the international ethical guidelines. Discussion This randomized controlled trial aims to evaluate interactive voice response technology in the context of resource-limited settings with a high burden of TB and high illiteracy rates. The software to be evaluated was developed using HCD and the intervention was based on the IMB model. The software is tailored to the local context and is interoperable with the MHI ecosystem. The HCD approach ensures higher usability of the MHI by integrating human factors in the prototype development. This research will contribute towards the understanding of the implementation and impact of the MHI on TB treatment outcomes and the health system, especially in LMICs. Trial registration ClinicalTrials.govNCT04709159. Registered on January 14, 2021.

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