Smoking CessationNCT05209451
Increasing Digital Equity and Access Among Rural Patients (IDEA) Study
A study testing Digital, evidence-based behavioral health program for smoking cessation, Bluetooth enabled iPad and Coaching Support in people with Smoking Cessation, run by Mayo Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Digital, evidence-based behavioral health program for smoking cessation, Bluetooth enabled iPad and Coaching Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2022to 17 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A Mayo Clinic Midwest patient (Mayo Clinic Rochester or Mayo Clinic Health System [MCHS]) with a Mayo Clinic number.
- Aged 18 years or older.
- Can read and speak in the English language. Based on 2019 data, 97% of our Rochester and MCHS patients speak English. The study will provide all participants with a smoking cessation program delivered through the Mayo Clinic patient portal. Currently, Mayo Clinic's portal services are not offered in languages other than English.
- Has a Minnesota, Iowa, or Wisconsin address currently or at date of most recent visit to Mayo Clinic.
- Rural resident based on RUCA codes derived from ZIP code of current or last known address.
- Has access to a telephone of any type (e.g., landline, smartphone). Access to a telephone is needed to complete the coaching support intervention and to follow-up with participants if there are issues with accessing the patient portal for the smoking cessation intervention.
Show all 13Show fewer
- Current smoker defined as one or more cigarettes (even a puff) smoked in the past 30 days (original criteria). This definition allows for enrollment of non-daily and/or light smoking enhancing the generalizability. In addition to cigarettes, cigarillos and cigars are combustible tobacco products and thus relevant as a focus for our study. Thus, the protocol was modified with IRB approval to change this criterion to include other combustible tobacco use. The final criterion was "Current smoker defined as one or more cigarettes, cigarillos, or cigars (even a puff) smoked in the past 30 days." To enhance the generalizability of our findings, we will enroll participants using other tobacco/nicotine products if cigarette, cigarillo or cigar smoking is the primary product used
- For past 3 months not enrolled in a program or use of cessation pharmacotherapy (original criterion). The protocol was modified with IRB approval to allow for ad hoc use to enhance generalizability. The final criterion was "For past 3 months not enrolled in a program or use of cessation pharmacotherapy other than ad hoc use, for example used nicotine gum or lozenge once or twice."
- Willing to make a quit smoking attempt.
- Has a patient portal account, or is willing to create a patient portal account.
- Has an email address to provide to study staff, or is willing to create an email address.
- Has digital access barriers defined by one or more of the following:
- based on participant ZIP code from current or last known address geocoded census block group indicates area of poor BB internet coverage; (b) no existing Mayo Clinic patient portal account or (c) has a Mayo Clinic patient portal account but has not used it in the past 5 years; (d) self-reports having no access to broadband (high speed) internet connection for personal use; and/or (e) self-reports low digital literacy defined with the screening question "How comfortable are you using technology to manage your health care remotely? For example, using patient online services (i.e., patient portal) to schedule appointments, check for test results, or send a message to your provider?" (included: not at all or a little comfortable).
Who cannot join
- Anyone not meeting all inclusion criteria will be excluded.
- Has participated in a behavioral smoking cessation program in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- Control Condition- no additional study intervention (n=30),
- Loaner Digital Device - participants will be loaned a Bluetooth enabled iPad with data plan coverage for the study duration (n=30),
- 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.
- Conditions
- Smoking Cessation
- Being tested
- Digital, evidence-based behavioral health program for smoking cessation, Bluetooth enabled iPad, Coaching Support
- Keywords
- Rural, Smoking, Smoking cessation, Treatment, Intervention, Digital, Literacy, Equity, Inclusion, Community Engagement
- Medical subject headings
- Smoking Cessation, Smoking, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital, evidence-based behavioral health program for smoking cessationBehavioural
Remotely delivered, 12-week smoking cessation program delivered through the patient portal. The program will deliver a smoking cessation intervention that links study participants to tailored, interactive and effective evidence-based smoking cessation resources.
Bluetooth enabled iPadOther
Bluetooth enabled iPad with data plan coverage that provides a personal Wi-Fi (Internet) hot spot for all home devices and allows for up to 64 GB of cellular data.
Coaching SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition - No additional study intervention | Active comparator | Subjects will receive a 12-week, digital, evidence-based behavioral health program for smoking cessation delivered through the patient portal and a written guide on existing digital access resources along with any other necessary material. Receives: Behavioral: Digital, evidence-based behavioral health program for smoking cessation |
| Loaner Digital Device | Experimental | Subjects will receive a 12-week, digital, evidence-based behavioral health program for smoking cessation delivered through the patient portal and a written guide on existing digital access resources along with any other necessary material. Participants in this group will also receive a loaned Bluetooth enabled iPad with data plan coverage for the study duration. Receives: Behavioral: Digital, evidence-based behavioral health program for smoking cessation; Other: Bluetooth enabled iPad |
| Loaner Digital Device + Coaching Support | Experimental | Subjects will receive a 12-week, digital, evidence-based behavioral health program for smoking cessation delivered through the patient portal and a written guide on existing digital access resources along with any other necessary material. Participants in this group will also receive a loaned Bluetooth enabled iPad with data plan coverage for the study duration plus up to six coaching call, 15-20 minutes in duration. Receives: Behavioral: Digital, evidence-based behavioral health program for smoking cessation; Behavioral: Coaching Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial engagement
Composite measure of assessment completion and use of online cessation program
Measured: 12 weeks
Secondary outcomes (3)
Smoking abstinence
Self-reported smoking abstinence
Measured: 4 and 12 weeks
Use of evidence-based smoking cessation treatment
Self-reported use of any cessation treatment
Measured: 4 and 12 weeks
Patient experience
Qualitative interviews of participants' experience with the interventions
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start11 Feb 2022
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christi Patten, Mayo Clinic
- Investigators
- Christi Patten, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209451
- Sponsor's protocol ID
- 21-011617
- Status last verified
- Sep 2024
- First submitted
- 10 Jan 2022
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kelpin S, Brockman TA, Decker PA, Young A, Boehmer K, Nguyen A, Kamath C, St Sauver J, Sinicrope PS, Sharma P, McCoy R, Allen S, Huang M, Pritchett J, Esterov D, Lampman M, Petersen C, Cheville A, Patten CA. Increasing digital equity to promote online smoking cessation program engagement among rural adults: a randomized controlled pilot trial. Commun Med (Lond). 2024 Oct 8;4(1):194. doi: 10.1038/s43856-024-00624-6.
PubMed 39375517Patten CA, Koller KR, King DK, Prochaska JJ, Sinicrope PS, McDonell MG, Decker PA, Lee FR, Fosi JK, Young AM, Sabaque CV, Brown AR, Borah BJ, Thomas TK. Aniqsaaq (To Breathe): Study protocol to develop and evaluate an Alaska Native family-based financial incentive intervention for smoking cessation. Contemp Clin Trials Commun. 2023 Apr 3;33:101129. doi: 10.1016/j.conctc.2023.101129. eCollection 2023 Jun.
PubMed 37091507Patten C, Brockman T, Kelpin S, Sinicrope P, Boehmer K, St Sauver J, Lampman M, Sharma P, Reinicke N, Huang M, McCoy R, Allen S, Pritchett J, Esterov D, Kamath C, Decker P, Petersen C, Cheville A. Interventions for Increasing Digital Equity and Access (IDEA) among rural patients who smoke: Study protocol for a pragmatic randomized pilot trial. Contemp Clin Trials. 2022 Aug;119:106838. doi: 10.1016/j.cct.2022.106838. Epub 2022 Jun 25.
PubMed 35760340
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Digital Equity and Access Among Rural Patients (IDEA) Study
- ClinicalTrials.gov ID
- NCT05209451
- Acronym / sponsor ID
- 21-011617
- Conditions
- Smoking Cessation
- Keywords
- Rural, Smoking, Smoking cessation, Treatment, Intervention, Digital, Literacy, Equity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Control Condition- no additional study intervention (n=30),
- Loaner Digital Device - participants will be loaned a Bluetooth enabled iPad with data plan coverage for the study duration (n=30),
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Condition - No additional study intervention | Active comparator | Behavioral: Digital, evidence-based behavioral health program for smoking cessationSubjects will receive a 12-week, digital, evidence-based behavioral health program for smoking cessation delivered through the patient portal and a written guide on existing digital access resources along with any other necessary material. |
| Loaner Digital Device | Experimental | Behavioral: Digital, evidence-based behavioral health program for smoking cessation, Other: Bluetooth enabled iPadSubjects will receive a 12-week, digital, evidence-based behavioral health program for smoking cessation delivered through the patient portal and a written guide on existing digital access resources along with any other necessary material. Participants in this group will also receive a loaned Bluetooth enabled iPad with data plan coverage for the study duration. |
| Loaner Digital Device + Coaching Support | Experimental | Behavioral: Digital, evidence-based behavioral health program for smoking cessation, Behavioral: Coaching SupportSubjects will receive a 12-week, digital, evidence-based behavioral health program for smoking cessation delivered through the patient portal and a written guide on existing digital access resources along with any other necessary material. Participants in this group will also receive a loaned Bluetooth enabled iPad with data plan coverage for the study duration plus up to six coaching call, 15-20 minutes in duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- A Mayo Clinic Midwest patient (Mayo Clinic Rochester or Mayo Clinic Health System [MCHS]) with a Mayo Clinic number.
- Aged 18 years or older.
- Can read and speak in the English language. Based on 2019 data, 97% of our Rochester and MCHS patients speak English. The study will provide all participants with a smoking cessation program delivered through the Mayo Clinic patient portal. Currently, Mayo Clinic's portal services are not offered in languages other than English.
- Has a Minnesota, Iowa, or Wisconsin address currently or at date of most recent visit to Mayo Clinic.
- Rural resident based on RUCA codes derived from ZIP code of current or last known address.
Key exclusion criteria (2 listed)
- Anyone not meeting all inclusion criteria will be excluded.
- Has participated in a behavioral smoking cessation program in the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital, evidence-based behavioral health program for smoking cessationRemotely delivered, 12-week smoking cessation program delivered through the patient portal. The program will deliver a smoking cessation intervention that links study participants to tailored, interactive and effective evidence-based smoking cessation resources. | Behavioural | Control Condition - No additional study intervention, Loaner Digital Device, Loaner Digital Device + Coaching Support |
| Bluetooth enabled iPadBluetooth enabled iPad with data plan coverage that provides a personal Wi-Fi (Internet) hot spot for all home devices and allows for up to 64 GB of cellular data. | Other | Loaner Digital Device |
| Coaching SupportSix 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. | Behavioural | Loaner Digital Device + Coaching Support |
Primary outcome
Trial engagement
Time frame: 12 weeks
Composite measure of assessment completion and use of online cessation program
3 secondary outcomes
Smoking abstinence
Time frame: 4 and 12 weeks
Use of evidence-based smoking cessation treatment
Time frame: 4 and 12 weeks
Patient experience
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Derived from this study: PubMed 39375517Kelpin S, Brockman TA, Decker PA, Young A, Boehmer K, Nguyen A, Kamath C, St Sauver J, Sinicrope PS, Sharma P, McCoy R, Allen S, Huang M, Pritchett J, Esterov D, Lampman M, Petersen C, Cheville A, Patten CA. Increasing digital equity to promote online smoking cessation program engagement among rural adults: a randomized controlled pilot trial. Commun Med (Lond). 2024 Oct 8;4(1):194. doi: 10.1038/s43856-024-00624-6.
- Derived from this study: PubMed 37091507Patten CA, Koller KR, King DK, Prochaska JJ, Sinicrope PS, McDonell MG, Decker PA, Lee FR, Fosi JK, Young AM, Sabaque CV, Brown AR, Borah BJ, Thomas TK. Aniqsaaq (To Breathe): Study protocol to develop and evaluate an Alaska Native family-based financial incentive intervention for smoking cessation. Contemp Clin Trials Commun. 2023 Apr 3;33:101129. doi: 10.1016/j.conctc.2023.101129. eCollection 2023 Jun.
- Derived from this study: PubMed 35760340Patten C, Brockman T, Kelpin S, Sinicrope P, Boehmer K, St Sauver J, Lampman M, Sharma P, Reinicke N, Huang M, McCoy R, Allen S, Pritchett J, Esterov D, Kamath C, Decker P, Petersen C, Cheville A. Interventions for Increasing Digital Equity and Access (IDEA) among rural patients who smoke: Study protocol for a pragmatic randomized pilot trial. Contemp Clin Trials. 2022 Aug;119:106838. doi: 10.1016/j.cct.2022.106838. Epub 2022 Jun 25.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christi Patten, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital, evidence-based behavioral health program for smoking cessation, Bluetooth enabled iPad and Coaching Support in people with Smoking Cessation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trial engagement (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05209451, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.