1000 Participants NeededMy employer runs this trial

Follow-up Support for Care Plan Engagement

Recruiting at 5 trial locations
PI
Overseen ByPrincipal Investigator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate strategies that help people adhere to their health plans. It tests three approaches to boost engagement with the My Own Health Report (MOHR) program: sending reminder messages, using a health navigator to guide participants, or a combination of both. The trial seeks adults who have completed a health assessment and are at risk due to low physical activity or poor diet. As an unphased trial, it offers a unique opportunity to explore personalized strategies for improving health habits.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on health behavior changes rather than medication changes.

What prior data suggests that these strategies are safe for participant engagement?

A previous study showed that sending text message reminders helped patients attend medical appointments more regularly and follow their doctor's advice better. This demonstrates that text messaging can be a safe and effective way to manage health. Another study found that using digital guides to assist patients in navigating healthcare resources improved patient involvement without safety concerns. These findings suggest that both the "R2 Message Only" and "R2 Navigation Only" strategies are well-received.

Combining these methods in the "R2 Message + R2 Navigation" strategy is also expected to be safe. Research on similar approaches has shown positive results without major side effects. Overall, the different strategies in MOHR Follow-up Support aim to boost engagement, and existing studies indicate they are safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance patient engagement with their care plans. Unlike traditional methods that rely solely on standard care, this trial investigates the impact of reminders and resources through messaging and navigation support. The unique approach of using both digital messages and health navigators aims to boost patient adherence and make healthcare more accessible and personalized. By potentially improving the effectiveness of care plan engagement, this trial could lead to better health outcomes and more efficient healthcare delivery.

What evidence suggests that this trial's strategies could be effective for increasing engagement in health behavior change activities?

This trial will evaluate different approaches to MOHR Follow-up Support to boost patient involvement and improve health outcomes. Participants in the "R2 Message Only" arm will receive reminders and helpful information, which studies have linked to better management of health habits and more frequent patient follow-ups. The "R2 Navigation Only" arm will provide guidance from a health navigator, helping patients adhere to their care plans and achieve better results. The "R2 Message + R2 Navigation" arm combines both strategies, with earlier trials showing promising results in enhancing patient participation and effectively tracking health progress. These methods aim to fill gaps in care and support patients in making healthier choices.16789

Are You a Good Fit for This Trial?

This trial is for adults 18 and older who are at risk for cancer due to low physical activity (less than 150 minutes/week) and poor diet (less than 5 servings of fruits/vegetables daily), attend a participating clinic, and have completed the MOHR health assessment. People with advanced illness or dementia, or who don't speak English or Spanish, can't join.

Inclusion Criteria

I am 18 years old or older.
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
See 1 more

Exclusion Criteria

I do not have any serious illnesses or dementia that would prevent me from joining the study.
My preferred language is not English or Spanish.
Incomplete or no MOHR assessment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the MOHR intervention with R2 Message and/or R2 Navigation strategies

6 months
Maximum of 12 navigator calls and 60 text messages

Follow-up

Participants are monitored for engagement and improvement in behavioral risk factors

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • MOHR Follow-up Support

Trial Overview

The study compares three ways to help people engage in healthy behaviors: reminders and resources sent by messages, reminders/resources provided through navigation support, and usual care. The goal is to see which method best encourages lasting health changes.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: R2 Navigation onlyExperimental Treatment2 Interventions
Group II: R2 Message OnlyExperimental Treatment2 Interventions
Group III: R2 Message + R2 NavigationExperimental Treatment3 Interventions
Group IV: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Testing the Impact of the MOHR Follow-up Support

Key outcomes include: 1) improvement in behavioral risk factors, 2) representative engagement with R2 Message and R2 Navigation, and 3) ...

Feasibility of Patient Navigation for Care Planning in Primary ...

Data: We used 3 data sources: (1) research recruitment field notes, (2) patient and navigator field notes about navigation sessions documented in MOHR, and (3) ...

Digital mental health treatment implementation playbook

A care pathway is a structured multidisciplinary plan that outlines that defines what happens, when it happens, and who does what from diagnosis through ...

Building Mutually Beneficial Collaborations Between Digital ...

In this paper, we report observational findings from the implementation of a digital navigator in a multidisciplinary mental health clinic in Sydney, Australia.

Improving Rural Health Through Telehealth-Guided Provider ...

The reports and assessments provide organizations with comprehensive, evidence-based information on common medical conditions and new healthcare technologies ...

Current and future use of RE-AIM and PRISM and its ...

strategies (Table 3) of R2 message and R2 Navigation will be further opportunities for Assist/Arrange to occur. Page 40. My Own Health Report ...

7.

nocklab.fas.harvard.edu

nocklab.fas.harvard.edu/file_url/989

Intervening on High-Risk Responses During Ecological ...

Thus, it is with good reason that some combination of follow-up contact, safety planning, and suicide risk assessment are often included in ...

A group resilience training program for people with multiple ...

READY is an Acceptance and Commitment Therapy-based group resilience-training program that has preliminary empirical support in promoting quality of life.

A Review of Alternatives in mHealth Clinical Trial Methods

A review of the ClinicalTrials.gov registry was conducted in. November 2015 to identify and examine current clinical trials involving mHealth ...