NCT07569224

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Dec 2029

Study Start

First participant enrolled

April 20, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

3.2 years

First QC Date

April 29, 2026

Last Update Submit

April 29, 2026

Conditions

Keywords

Implementation strategypatient follow-up

Outcome Measures

Primary Outcomes (3)

  • Number of MOHR risk factors

    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).

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

  • REACH - specifically representative engagement

    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.

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

  • Patient experience

    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).

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

Study Arms (4)

Control Arm

ACTIVE COMPARATOR

Standardized version of usual care

Behavioral: Regular care

R2 Message Only

EXPERIMENTAL

Reminder and Resources Messages sent to patient

Behavioral: Providing reminder and resources via messagesBehavioral: Regular care

R2 Navigation only

EXPERIMENTAL

Reminder and Resources provided to patient via health navigator

Behavioral: Reminder and resources sent via navigationBehavioral: Regular care

R2 Message + R2 Navigation

EXPERIMENTAL

Both reminder and resources messages and navigation provided to the patient

Behavioral: Providing reminder and resources via messagesBehavioral: Reminder and resources sent via navigationBehavioral: Regular care

Interventions

Patients will be provided reminders and resources using messages sent to patients.

R2 Message + R2 NavigationR2 Message Only
Regular careBEHAVIORAL

Regular (standard) care provided by healthcare provider team

Control ArmR2 Message + R2 NavigationR2 Message OnlyR2 Navigation only

Patients will be provided reminders and resources using health navigators calling the patients.

R2 Message + R2 NavigationR2 Navigation only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

UCHealth Women's Integrated Services in Health (WISH)

Denver, Colorado, 80045, United States

RECRUITING

UCHealth Cherry Creek Medical Center

Denver, Colorado, 80206, United States

RECRUITING

UCHealth Internal Medical Clinic - Lowry

Denver, Colorado, 80230, United States

RECRUITING

UCHealth Lone Tree Medical Center

Lone Tree, Colorado, 80124, United States

RECRUITING

UCHealth Family Medicine - Westminster

Westminster, Colorado, 80021, United States

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: type 2 hybrid comparative effectiveness implementation trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 6, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Due to HIPAA we cannot share IPD from EHR.

Locations