Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-31 @ 4:05 AM
Study NCT ID:
NCT05209451
Status:
COMPLETED
Last Update Posted:
2024-09-20
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing Digital Equity and Access Among Rural Patients (IDEA) Study
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Increasing Digital Equity and Access Among Rural Patients (IDEA) Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: