跳至主要内容
临床试验/NCT05436041
NCT05436041
已完成
不适用

Pilot Trial of Nutri, a Clinical Decision Support Software to Improve Diet Goal-Setting in Primary Care

University of Texas at Austin1 个研究点 分布在 1 个国家目标入组 82 人2022年6月14日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Type 2 Diabetes
发起方
University of Texas at Austin
入组人数
82
试验地点
1
主要终点
Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavioral Intention
状态
已完成
最后更新
2年前

概览

简要总结

The investigators will conduct a pilot cluster randomized trial of Nutri, a clinical decision support software to support collaborative diet goal setting in primary care. Nutri is designed within the Chronic Care Model framework, specifically with the intention of leveraging clinical information systems to connect clinical care with patients' lives in the community setting. Nutri is based on the Theory of Planned Behavior and uses collaborative goal setting between the patient and provider to identify a behavioral intention (i.e., diet goal) and improve goal self-efficacy by improving attitudes/outcome expectations, subjective norms/social support, and perceived behavioral control.

In this pilot trial, the intervention group (N=10 primary care providers [PCPs], N=40 patients) receives collaborative diet goal setting via Nutri, and the control group receives usual care(N=10 PCP, N=40 patients). Before and after the appointment, patients will report food they consumed over the last 24 hours via the dietary recall tool, ASA24 and respond to surveys about behavioral intention and self-efficacy. Intervention PCPs will be alerted when the Nutri workflow is available for a patient and asked to complete it during their visit with that patient.

注册库
clinicaltrials.gov
开始日期
2022年6月14日
结束日期
2022年12月20日
最后更新
2年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Marissa Burgermaster

Assistant Professor

University of Texas at Austin

入排标准

入选标准

  • Provision of signed and dated informed consent form
  • Diagnosed with pre-diabetes or type 2 diabetes, or at risk for type 2 diabetes
  • Have a scheduled medical appointment with a study enrolled PCP within the study enrollment period
  • Fluent in either English or Spanish
  • Access to a computer, tablet, or smartphone and reliable internet
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • HIPAA authorization for Health Information Exchange

排除标准

  • Currently pregnant
  • Diagnosed with an eating disorder

结局指标

主要结局

Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavioral Intention

时间窗: 1-day post medical encounter

Patient self-report of a diet goal set during medical appointment, coded y/n

Variance and Within-Provider Covariance of Patient Change in Diet Quality (measured via Healthy Eating Index)

时间窗: Patient pre-assessment and 7-day post medical encounter

Change in diet quality measured via the Healthy Eating Index (HEI) score calculated from 24-hour recall, 0-100 score range, higher score means better outcome.

Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior)

时间窗: 1-day post medical encounter

Patient self-report of self-efficacy (ie, confidence) in changing their diet after appointment, 7-point Likert scale, a higher score means a better outcome

次要结局

  • Completion of patient ASA24 survey(patient pre-assessment & 7 days post-appointment)
  • Impact of Nutri on Patient Diet Quality (measured via Healthy Eating Index)(Patient pre-assessment and 7 days post-medical encounter)
  • Nutri (Intervention) Usability(PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment)
  • Impact of Nutri on Patient Self-Reported Dietary Behavioral Intention(1 day post-medical encounter)
  • Impact of Nutri on Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior), measured via questionnaire(1 day post-medical encounter)
  • Number and timeline of PCPs and patients recruited into the study(through study completion, expected to be at 8 weeks after enrollment)
  • Number and timeline of PCPs and patients who drop out of the study(through study completion,expected to be at 8 weeks after enrollment)

研究点 (1)

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