Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05209451 |
| Other study ID # |
21-011617 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 11, 2022 |
| Est. completion date |
February 17, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Mayo Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this research is to learn more about how access to digital resources impacts
healthcare and smoking cessation in rural areas of Minnesota, Iowa, and Wisconsin.
Aim 1: Conduct a pragmatic randomized clinical trial and use mixed methods to assess the
impact of providing access to technology and/or coaching support on participation in and
response to a digital, evidence-based behavioral health program for smoking cessation.
Aim 2: Assess the feasibility and patient experience of providing electronic remuneration and
a loaner device with data plan coverage to access the Internet for remote clinical trials
participation.
Description:
Rural Community Advisory Committee (CAC) The investigators partnered with the Mayo Clinic
Community Engagement Program and Center for Health Equity and Community Engaged Research
(CHCR) to form a study-specific Community Advisory Committee (CAC) consisting of 13 members.
The CAC is comprised of rural patient advocates, community members and other stakeholders
(e.g., MCHS clinicians, Minnesota Rural Broadband Coalition representative). The charge of
the CAC is to provide advice and co-design all study materials, digital health access
interventions, recruitment messaging, and study dissemination materials and strategies. The
CAC met three times with the study team virtually by zoom in September, October, and November
of 2021, with each meeting about 90 minutes duration. Members provided feedback on the study
protocol including the recruitment messaging and materials, as well as the electronic
remuneration process, smoking cessation program, and digital access interventions. The
protocol and study materials that are included incorporated this feedback. The CAC will meet
four times in 2022. Members will receive a $150 honorarium for each meeting attended.
Study Design
This pragmatic trial is a three-arm, randomized, parallel group design with 90 participants.
All participants will receive a 12-week, digital, evidence-based behavioral health program
for smoking cessation delivered through the patient portal. All participants will also
receive a written guide on existing digital access resources and any other necessary
materials. Participants will be stratified based on geographic location (MN, IA, WI) and
randomized with 1:1:1 allocation to one of three digital health access intervention groups:
1. Control Condition- no additional study intervention (n=30),
2. Loaner Digital Device - participants will be loaned a Bluetooth enabled iPad with data
plan coverage for the study duration (n=30),
3. Loaner Digital Device + Coaching Support - participants will receive the same loaner
device described for Group 2 plus up to six coaching calls, 15-20 minutes each in
duration. The research coach will use motivational interviewing and goal setting to
enhance the participant's technology access and use and digital literacy (n=30).
All participants will complete study assessments at baseline, and at 4 and 12-weeks
post-randomization. Outcomes will be assessed using mixed methods. The primary outcome is a
composite measure of trial engagement derived from measures of online smoking cessation
program engagement (e.g., opening portal messages) and study assessment completion. Secondary
outcomes are smoking-related treatment response (self-reported smoking abstinence and use of
evidence-based cessation treatment). We will also assess patient experience.
Rationale for the design: The study design will allow us to evaluate the impact of providing
the iPad device, or written resource materials on accessing the Internet, without the
coaching support. The Investigators can therefore draw causal inferences about key components
of the intervention that are necessary for success. From our qualitative work assessing
patient experience, the Investigators will learn in this project if more intensive, tailored
education and support is necessary to address rural culture and contextual factors,
consistent with the Digital Health Equity Framework (Crawford et al., 2020). The study design
has utility for the Office of Clinical Trials as well as decision makers within the MCHS
about the resources needed for rural patients to access clinical trials and health care
remotely.
