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临床试验/NCT06730737
NCT06730737尚未招募不适用

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

Trinity Health-Livonia2 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
350
试验地点
2
主要终点
Lifestyle Readiness to Change and Confidence to Change questionnaires

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Lifestyle Readiness to Change and Confidence to Change questionnaires

时间窗: 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.

次要结局

  • Satisfaction, intent to changve lifestyle behavior, follow up clinic visit(18 months)

研究者

发起方
Trinity Health-Livonia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Keyes, MD, MPH

Associate Chair, Academic Affairs, Principal Investigator

Trinity Health-Livonia

研究点 (2)

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