Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06730737

Lifewise Preventive Video Education in Primary Care

It is widely accepted that prevention is far more impactful than curative medicine and must be included in primary care. In a previous pilot study, we evaluated passive video preventive lifestyle education in the emergency department. The current study is a randomized prospective trial assessing the practicality and impact of a brief interactive educational video intervention to patients during primary care clinic visits.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trinity Health-Livonia Hospital and Affiliated Clinics

Livonia, Michigan, 48154, United States

Location contact

Ali Jafri, DO

CONTACT

Daniel Keyes, MD, MPH

CONTACT

David Steinberger, MD

CONTACT

Dylan L Arroyo, BSE

CONTACT

Laurie McHugh, BS

CONTACT

[email protected]

734-655-2763

About this study

Background and Summary of Objectives: It is widely accepted that prevention is far more impactful than curative medicine concerning overall health efficacy. The primary care setting faces the challenges of increasingly important time constraints and conflicting priorities. However, prevention is a priority regarding the improvement in health outcomes. In a previous pilot study, we investigated the impact of a simple instructional video on patients' willingness to change in the emergency department setting. The initial intervention was passive, requiring subjects to watch a video without interaction. The current study evaluates the practicality and impact of bringing a brief interactive educational video intervention to patients at the primary care clinic visit.

Summary of Study Design This randomized, non-blinded prospective study of "just in time" education for adult patients presenting to the primary care clinic immediately following their primary care appointment.

Patients will be randomized to receive the interactive intervention video during this encounter with the practitioner in the clinic. The intervention is an interactive video with a duration of approximately 10-15 minutes. The video is interactive because it asks the patients to answer simple questions about the content in the video to keep them engaged with the content. For instance, if the participant indicates that they do not smoke, the video will "skip" the smoking cessation education and move directly to the other prevention domains. Before leaving the clinic, all patients will be presented with a questionnaire about their readiness and confidence to initiate lifestyle changes (transtheoretical stage of change measured on a "readiness ruler") and additional survey instruments. Most of these questions will come from existing validated scales, including the Gillespie & Lenz behavior modification tool, the Pittsburgh Sleep Quality Index, and select questions from the US HCAHPS Patient Satisfaction Survey. They will be asked for access to their medical record and their willingness to be contacted for a follow-up survey.

Outcome measures:

The study's primary outcome will be the results of the Lifestyle Readiness to Change and Confidence to Change questionnaires. Secondary outcomes will include satisfaction with the primary care clinic visit using select questions from HCAHPS, and whether they intend to change any specific lifestyle behavior (dichotomous, yes/no) and, if yes, to specific which one(s), seeking medical care outside of the clinic visit as determined by a review of the patient's medical record at intervals of 30 days and six months. HIV will not be evaluated outside of its inclusion in the Charlson Comorbidity Index (CCI). A follow-up survey at approximately 3-12 months will evaluate new diagnoses related to chest pain and ask about the individual's lifestyle changes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults between the ages of 18 and 80, inclusive.

Exclusion criteria

  • Non-English-speaking patient
  • Unable or unwilling to consent to the study
  • Unable or unwilling to hear a video on a smartphone or computer tablet
  • The patient is in hospice care
  • Patients with advanced dementia, in the opinion of the person administering the survey

Treatment and study plan

Video preventive education

Other

Interactive video that teaches the subject about the overall importance of prevention, smoking cessation, proper diet, exercise, and sleep.

Primary outcomes

  1. Lifestyle Readiness to Change and Confidence to Change questionnaires

    Time frame: Immediately following exposure to the intervention or not (both arms receive the questionnaires)

    The study's primary outcome will be the results of the Lifestyle Readiness to Change and Confidence to Change questionnaires.

Secondary outcomes

  1. Satisfaction, intent to changve lifestyle behavior, follow up clinic visit

    Time frame: 18 months

    satisfaction with the primary care clinic visit using select questions from HCAHPS, and whether they intend to change any specific lifestyle behavior (dichotomous, yes/no) and, if yes, to specific which one(s), seeking medical care outside of the clinic visit as determined by a review of the patient's medical record within approximately six months. A follow-up survey at approximately 3-12 months will evaluate new diagnoses related to chest pain and ask about the individual's lifestyle changes.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Keyes, MD, MPH

CONTACT

[email protected]

734-931-0734

Sponsors and collaborators

Lead sponsor

Trinity Health-Livonia

Other

Registry information

Official study title

Brief Lifestyle Medicine Preventive Randomized Prospective Interactive Educational Intervention in the Primary Care Clinic

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 12, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.