跳至主要内容
临床试验/NCT07569224
NCT07569224招募中不适用

Testing the Impact of the My Own Health Report Intervention With 3 Distinct Options for Structured Follow-up as Compared to a Control Condition

University of Colorado, Denver6 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年6月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
6
主要终点
Number of MOHR risk factors

研究概览

简要总结

This study will evaluate the impact of 3 different strategies to increase engagement of participants in My Own Health Report (MOHR) and health behavior change activities over time. This study will evaluate the level of engagement, outcomes, cost and cost-effectiveness of these strategies.

详细描述

In previous pilot studies was found that patients in clinics randomized to the MOHR intervention vs. control significantly improved physical activity (p < 0.001) and diet risk behaviors (p < 0.001), as well as other risk factors. However, two gaps were identified. First, clinic partners voiced a need for a more flexible menu of delivery options to feasibly adopt and sustain the intervention. Second, to achieve sustained behavior change, particularly for those with unmet social needs, clinics need to provide structured follow-up. Structured follow-up bundles are part of the ERIC strategy of "enhance uptake and adherence (among patients)" and "technical assistance." In other work, additional reminders and resources improved outcomes of goal-setting interventions in general and among those with unmet social needs, so the study team operationalized these to be delivered either electronically (Reminder and Resources (R2) Message) or by a person (R2 Navigation). To fill these two gaps, we engaged with a subset of both UCHealth and rural primary care clinics and patient advisors to co-develop a menu of delivery options for the MOHR intervention and also a menu of options for the R2 Message and R2 Navigation strategy bundles.

In a randomized comparative effectiveness-implementation trial the study team will enroll 1,000 adult patients with two or more cancer risks (including both insufficient physical activity and fruit/vegetable intake). The study team will evaluate the outcomes of R2 Message and R2 Navigation alone or in combination. Key outcomes include: 1) improvement in behavioral risk factors, 2) representative engagement with R2 Message and R2 Navigation, and 3) improvement in practice value outcomes, including patient experience ratings.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults, aged 18 years and older.
  • Completion of the MOHR health risk assessment and goal-setting tool
  • Score in the "at-risk" range on both of the following cancer risk assessments: 1) Physical activity risk: less than 150 minutes per week of moderate to vigorous physical activity; Diet risk: Less than 5 servings daily of combined fruit/vegetables
  • Patient at one of the participating clinics

排除标准

  • Incomplete or no MOHR assessment
  • Language preference/proficiency other than English or Spanish
  • Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation. Examples include - Indices of advanced illness and frailty, such as dementia (ICD-10 codes F01.50, F01.51, F02.80, F02.81, F03.90, F03.91, F10.27, F10.97, G31.09, G31.83 or dementia medication of Donepezil • Galantamine • Rivastigmine, Memantine, or Donepezil-memantine)).

研究组 & 干预措施

R2 Message Only

Experimental

Reminder and Resources Messages sent to patient

干预措施: Regular care (Behavioral)

R2 Message + R2 Navigation

Experimental

Both reminder and resources messages and navigation provided to the patient

干预措施: Providing reminder and resources via messages (Behavioral)

R2 Message + R2 Navigation

Experimental

Both reminder and resources messages and navigation provided to the patient

干预措施: Reminder and resources sent via navigation (Behavioral)

R2 Message + R2 Navigation

Experimental

Both reminder and resources messages and navigation provided to the patient

干预措施: Regular care (Behavioral)

R2 Navigation only

Experimental

Reminder and Resources provided to patient via health navigator

干预措施: Reminder and resources sent via navigation (Behavioral)

R2 Navigation only

Experimental

Reminder and Resources provided to patient via health navigator

干预措施: Regular care (Behavioral)

Control Arm

Active Comparator

Standardized version of usual care

干预措施: Regular care (Behavioral)

R2 Message Only

Experimental

Reminder and Resources Messages sent to patient

干预措施: Providing reminder and resources via messages (Behavioral)

结局指标

主要结局

Number of MOHR risk factors

时间窗: From enrollment to the follow-up survey timepoint at 2 months.

Primary effectiveness outcome measured on scale from -6 to +6 as change of the number of risk factors improved. MOHR questions are organized into 6 risk areas: 1) intake of fruits and vegetables; 2) high sugar beverages; 3) fast food; 4) physical activity; 5) stress; and 6) sleep. Each risk factor is evaluated as low risk, medium risk, or high risk. Level of improvement in risk factors outcome will be a count score from -6 to 6 (any improvement or decrement in level of risk in each factor will count as 1 or -1).

REACH - specifically representative engagement

时间窗: From enrollment to the follow-up survey timepoint at 6 months.

Primary implementation outcome. Representative engagement: Engagement during the follow-up period involves interactions over time of the participant with either or both a navigator or text messages . Engagement will be assessed percent of navigator calls completed (maximum of 12 over 6 months) and percent of text messages successfully sent (maximum of 60 over 6 months). To assess whether engagement is representative our primary assessments will be if there is differential engagement across conditions (e.g., an interaction effect) based on 1) number of baseline social needs, 2) Latine vs. non Latine ethnicity or 3) digital literacy.

Patient experience

时间窗: From enrollment to the follow up survey time point at 6 months.

Primary practice value outcome measured by change in mean score on Patient Assessment of Quality-of-Care subscales of goal setting/tailoring and follow-up/coordination (PACIC). Scale ranges from almost never (indicating the worst patient experience) to almost always (indicating the best patient experience).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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