Testing the Impact of the MOHR Follow-up Support
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Providing reminder and resources via messages
BehavioralPatients will be provided reminders and resources using messages sent to patients.
Reminder and resources sent via navigation
BehavioralPatients will be provided reminders and resources using health navigators calling the patients.
Regular care
BehavioralRegular (standard) care provided by healthcare provider team
Treatment groups
1,000 Participants
are divided into 4 treatment groupsGroup A: Control ArmActive comparator 1 intervention
Group B: R2 Message OnlyExperimental treatment 2 interventions
Group C: R2 Navigation onlyExperimental treatment 2 interventions
Group D: R2 Message + R2 NavigationExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
From enrollment to the follow-up survey timepoint at 2 months.2
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.
Time frame
From enrollment to the follow-up survey timepoint at 6 months.3
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).
Time frame
From enrollment to the follow up survey time point at 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov