Primary Care PatientsNCT07569224
Testing the Impact of the MOHR Follow-up Support
A study testing Providing reminder and resources via messages, Reminder and resources sent via navigation and Regular care in people with Primary Care Patients and Primary Care Center, run by University of Colorado, Denver at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Care Patients, Primary Care Center
- What is being tested?
- Providing reminder and resources via messages, Reminder and resources sent via navigation and Regular care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 6 sitesUnited States
- Study dates
- 2 Jun 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults, aged 18 years and older.
- Completion of the MOHR health risk assessment and goal-setting tool
- Score as medium risk or high risk in any of the following risk areas from MOHR tool: 1) fruit and vegetable intake; 2) sugar-sweetened beverages; 3) fast food; 4) physical activity; 5) stress; and 6) sleep
- Patient at one of the participating clinics
Who cannot join
- 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)).
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Rebekah Gomes, 303-724-3115, rebekah.gomes@cuanschutz.edu
Amy Huebschmann
- Recruiting
UCHealth Women's Integrated Services in Health (WISH)
Denver, Colorado, 80045
Rebekah Gomes, 303-724-3115, rebekah.gomes@cuanschutz.edu
- Recruiting
UCHealth Cherry Creek Medical Center
Denver, Colorado, 80206
Rebekah Gomes, 303-724-3115, rebekah.gomes@cuanschutz.edu
Amy Huebschmann
- Recruiting
UCHealth Internal Medical Clinic - Lowry
Denver, Colorado, 80230
Rebekah Gomes, 303-724-3115, rebekah.gomes@cuanschutz.edu
Amy Huebschmann
- Recruiting
UCHealth Lone Tree Medical Center
Lone Tree, Colorado, 80124
Rebekah Gomes, 303-724-3115, rebekah.gomes@cuanschutz.edu
Amy Huebschmann
- Recruiting
UCHealth Family Medicine - Westminster
Westminster, Colorado, 80021
Rebekah Gomes, 303-724-3115, rebekah.gomes@cuanschutz.edu
Amy Huebschmann
About this study
Official title: Testing the Impact of the My Own Health Report Intervention With 3 Distinct Options for Structured Follow-up as Compared to a Control Condition
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.
Read the detailed description
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.
- Conditions
- Primary Care Patients, Primary Care Center
- Being tested
- Providing reminder and resources via messages, Reminder and resources sent via navigation, Regular care
- Keywords
- Implementation strategy, patient follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Providing reminder and resources via messagesBehavioural
Patients will be provided reminders and resources using messages sent to patients.
Reminder and resources sent via navigationBehavioural
Patients will be provided reminders and resources using health navigators calling the patients.
Regular careBehavioural
Regular (standard) care provided by healthcare provider team
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Standardized version of usual care Receives: Behavioral: Regular care |
| R2 Message Only | Experimental | Reminder and Resources Messages sent to patient Receives: Behavioral: Providing reminder and resources via messages; Behavioral: Regular care |
| R2 Navigation only | Experimental | Reminder and Resources provided to patient via health navigator Receives: Behavioral: Reminder and resources sent via navigation; Behavioral: Regular care |
| R2 Message + R2 Navigation | Experimental | Both reminder and resources messages and navigation provided to the patient Receives: Behavioral: Providing reminder and resources via messages; Behavioral: Reminder and resources sent via navigation; Behavioral: Regular care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: From enrollment to the follow-up survey timepoint at 2 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).
Measured: From enrollment to the follow up survey time point at 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start2 Jun 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Care PatientsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- type 2 hybrid comparative effectiveness implementation trial
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569224
- Sponsor's protocol ID
- 25-0224.cc
- Other IDs
- 1R01CA282292-01A1
- Status last verified
- Oct 2026
- First submitted
- 29 Apr 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to HIPAA we cannot share IPD from EHR.
Publications
Dunston ER, Huebschmann AG, Birru E, Brtnikova M, Ford BS, Gomes R, White KA, Nederveld A, Bolden DM, Perez Jolles M, Broaddus-Shea ET, Trinkley KE, Ritzwoller DP, Creel LM, Ying J, L'Hotta AJ, Glasgow RE. Comparing different forms of structured follow-up support in the treatment of multiple health risks for chronic disease: a randomized controlled trial protocol. Implement Sci. 2026 Jul 25;21(1):60. doi: 10.1186/s13012-026-01527-x.
PubMed 42920163
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Impact of the My Own Health Report Intervention With 3 Distinct Options for Structured Follow-up as Compared to a Control Condition
- ClinicalTrials.gov ID
- NCT07569224
- Acronym / sponsor ID
- 25-0224.cc
- Conditions
- Primary Care Patients, Primary Care Center
- Keywords
- Implementation strategy, patient follow-up
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- type 2 hybrid comparative effectiveness implementation trial
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Behavioral: Regular careStandardized version of usual care |
| R2 Message Only | Experimental | Behavioral: Providing reminder and resources via messages, Behavioral: Regular careReminder and Resources Messages sent to patient |
| R2 Navigation only | Experimental | Behavioral: Reminder and resources sent via navigation, Behavioral: Regular careReminder and Resources provided to patient via health navigator |
| R2 Message + R2 Navigation | Experimental | Behavioral: Providing reminder and resources via messages, Behavioral: Reminder and resources sent via navigation, Behavioral: Regular careBoth reminder and resources messages and navigation provided to the patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults, aged 18 years and older.
- Completion of the MOHR health risk assessment and goal-setting tool
- Score as medium risk or high risk in any of the following risk areas from MOHR tool: 1) fruit and vegetable intake; 2) sugar-sweetened beverages; 3) fast food; 4) physical activity; 5) stress; and 6) sleep
- Patient at one of the participating clinics
Key exclusion criteria (3 listed)
- 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)).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Providing reminder and resources via messagesPatients will be provided reminders and resources using messages sent to patients. | Behavioural | R2 Message + R2 Navigation, R2 Message Only |
| Reminder and resources sent via navigationPatients will be provided reminders and resources using health navigators calling the patients. | Behavioural | R2 Message + R2 Navigation, R2 Navigation only |
| Regular careRegular (standard) care provided by healthcare provider team | Behavioural | Control Arm, R2 Message + R2 Navigation, R2 Message Only, R2 Navigation only |
Primary outcome
Number of MOHR risk factors
Time frame: 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
Time frame: From enrollment to the follow-up survey timepoint at 2 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
Time frame: From enrollment to the follow up survey time point at 2 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Derived from this study: PubMed 42920163Dunston ER, Huebschmann AG, Birru E, Brtnikova M, Ford BS, Gomes R, White KA, Nederveld A, Bolden DM, Perez Jolles M, Broaddus-Shea ET, Trinkley KE, Ritzwoller DP, Creel LM, Ying J, L'Hotta AJ, Glasgow RE. Comparing different forms of structured follow-up support in the treatment of multiple health risks for chronic disease: a randomized controlled trial protocol. Implement Sci. 2026 Jul 25;21(1):60. doi: 10.1186/s13012-026-01527-x.
- Individual participant dataSharing planned: No. Due to HIPAA we cannot share IPD from EHR.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Providing reminder and resources via messages, Reminder and resources sent via navigation and Regular care in people with Primary Care Patients and Primary Care Center, run by University of Colorado, Denver at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator ((303) 724-2268, amy.huebschmann@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of MOHR risk factors (time frame: From enrollment to the follow-up survey timepoint at 2 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07569224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.