Mobile Health-based Motivational Interviewing to Promote COVID-19 Vaccination

• Sponsor: Oklahoma State University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05977192
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 5
• Patients Per Site: 30
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the preliminary efficacy and acceptability of an mobile Health-based motivational interviewing (MI) intervention to promote SARS-CoV-2 vaccination (MOTIVACC) compared to traditional phone-based MI.

Condition or Disease	Intervention/Treatment	Phase
Vaccination Hesitancy	Behavioral: Standard MI; Behavioral: Intensive MI; Behavioral: MOTIVACC; Behavioral: Ecological momentary assessment (EMA) messages	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Mobile Health-based Motivational Interviewing to Promote Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccination in Oklahomans
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard MI	Behavioral: Standard MI; One phone-based MI session; Behavioral: Ecological momentary assessment (EMA) messages; EMA messages focused on vaccinations and health
Experimental: Intensive MI	Behavioral: Intensive MI; Four phone-based MI sessions; Behavioral: Ecological momentary assessment (EMA) messages; EMA messages focused on vaccinations and health
Experimental: MOTIVACC	Behavioral: MOTIVACC; mHealth-based MI; Behavioral: Ecological momentary assessment (EMA) messages; EMA messages focused on vaccinations and health

Outcome Measures

Primary Outcome Measures

1. Changes in vaccine hesitancy and confidence [Baseline and follow-up (8 weeks)]

2. Changes in intention to receive the vaccine [Baseline and follow-up (8 weeks)]

Secondary Outcome Measures

1. Changes in expectations related to vaccines [Baseline and follow-up (8 weeks)]

2. Changes in self-efficacy [Baseline and follow-up (8 weeks)]

3. Changes in ambivalence [Baseline and follow-up (8 weeks)]

4. Changes in value-behavior discrepancy [Baseline and follow-up (8 weeks)]

5. Number of participants who receive the COVID-19 vaccine [Follow-up (8 weeks)]

Other Outcome Measures

1. Percentage of total of ecological momentary assessment messages opened/viewed [8 weeks (from baseline to follow up)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 18 years

• Reside in a rural area

• No previous dose of a SARS-CoV-2 vaccine

• Speak English

• Able to provide informed consent

Exclusion Criteria:

• A cognitive or other disability that inhibits smart phone use

• Inability to participate because of medical or psychiatric conditions diagnosed by a physician/clinician

• Enrollment in other COVID-19 research; pregnant or lactating

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
2	Oklahoma State University	Stillwater	Oklahoma	United States	74078

Sponsors and Collaborators

• Oklahoma State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ABraun, Assistant Professor, Oklahoma State University
• ClinicalTrials.gov Identifier: NCT05977192
• Other Study ID Numbers: IRB-22-282-STW
• First Posted: Aug 4, 2023
• Last Update Posted: Aug 4, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 4, 2023