Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
780 participants
INTERVENTIONAL
2016-05-31
2017-07-31
Brief Summary
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Detailed Description
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Patients with an upcoming appointment and who meet study inclusion criteria will be invited to participate in the study, which will begin with an online baseline survey. In addition, patients in the intervention group will complete an online health risk intervention (HRI) that assesses and intervenes on the four cancer risk behaviors targeted in the intervention-cigarette smoking, risky drinking, noncompliance with national guidelines for physical activity, and overweight and obesity-as well depression. It will also assess whether participants have received cancer screenings recommended by age and gender.
After the HRI session, intervention participants will have access to the TTM CTIs targeting their risk factors during the next six months. Patients assigned to the usual care condition will receive care as usual.
Providers at the six clinics assigned to intervention will receive training on the TTM and the clinical dashboard. They will have access to the dashboard via the patient electronic medical record (EMR) during the intervention period, and will be expected to use the dashboard to deliver the one-on-one component of the TTM intervention. The clinical dashboard will:
1. Report whether the participant has received recommended cancer screenings;
2. Summarize data on targeted behavioral risks for cancer;
3. Summarize data on level of depression;
4. For each cancer risk behavior, show stage of change for meeting recommended guidelines; if at least mild depression show stage of change for using healthy strategies to manage depression; and
5. For each cancer risk behavior and depression management, provide stage-matched scripts providers can use to help participants progress to the next stage of change or to prevent relapse to an earlier stage.
Intervention group providers will deliver the dashboard-guided session at the patient's next clinic visit. The dashboard will be updated as the participant completes CTI sessions post-visit. Study participants who return to the clinic for any reason during the intervention period will be flagged, and the provider will use the dashboard to review progress and deliver updated stage-matched guidance.
All study participants will receive an online survey to assess outcomes at 6 and 12 months follow-up. Participants who don't complete the online survey within two weeks will be contacted by a survey research company to complete the survey by phone.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PCPHC intervention
PCPHC intervention during 6-month intervention period plus study assessments at baseline, 6, and 12 months
PCPHC
Mobile-delivered health risk intervention (HRI), computer-tailored interventions (CTIs), text messages; provider-delivered one-on-one session guided by clinical dashboard
Usual care
Primary care as usual
Usual care
Usual primary care plus study assessments at baseline, 6, and 12 months
Usual care
Primary care as usual
Interventions
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PCPHC
Mobile-delivered health risk intervention (HRI), computer-tailored interventions (CTIs), text messages; provider-delivered one-on-one session guided by clinical dashboard
Usual care
Primary care as usual
Eligibility Criteria
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Inclusion Criteria
1. Cigarette smoker
2. Exceeds recommended limits for alcohol intake
3. Does not meet national guidelines for physical activity
4. Overweight or obese
Exclusion Criteria
2. Currently undergoing cancer treatment
3. Serious medical condition that could prevent participation in the study for a full year
4. History of mania, schizophrenia, or other psychoses
5. Admitted to an inpatient mental health facility within the previous 2 years
6. Currently enrolled in the In It to Quit Study at the Community Health Center, Inc.
7. Unable to read English or Spanish
8. Unable to receive text messages
Note: Risky drinkers who screen positive for alcohol dependence will not be eligible for the intervention's risky drinking program, which focuses on limiting drinking to national guidelines. Treatment and control participants who screen positive for alcohol dependence and who are not engaging in any of the other targeted cancer risk behaviors will screen out of the study.
21 Years
75 Years
ALL
Yes
Sponsors
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Community Health Center, Inc.
INDUSTRY
Pro-Change Behavior Systems
OTHER
Responsible Party
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Deborah Levesque
Chief Science Officer
Principal Investigators
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Deborah A Levesque, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Pro-Change Behavior Systems
Locations
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Connecticut Health Center, Inc.
Middletown, Connecticut, United States
Pro-Change Behavior Systems, Inc.
South Kingstown, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Agency for Healthcare Policy and Research. CAHPS 2.0 survey and reporting kit. Rockville, MD: Agency for Healthcare Policy and Research; 1999.
Cantril H. The pattern of human concerns. New Brunswick, NJ: Rutgers University Press; 1965.
Centers for Disease Control and Prevention. Measuring Healthy Days: Population Assessment of Health-Related Quality of Life. Atlanta, GA; 2000.
Duke CC, Lynch WD, Smith B, Winstanley J. Validity of a New Patient Engagement Measure: The Altarum Consumer Engagement (ACE) Measure. Patient. 2015 Dec;8(6):559-68. doi: 10.1007/s40271-015-0131-2.
Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
Graham JW, Flay BR, Johnson CA, Hansen WB, Collins LM. Group comparability: A multiattribute utility measurement approach to the use of random assignment with small numbers of aggregated units. Evaluation Review 1984;8(2):247-60.
Hargraves JL, Hays RD, Cleary PD. Psychometric properties of the Consumer Assessment of Health Plans Study (CAHPS) 2.0 adult core survey. Health Serv Res. 2003 Dec;38(6 Pt 1):1509-27. doi: 10.1111/j.1475-6773.2003.00190.x.
Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
Prochaska JO, Redding C, Evers K. The Transtheoretical model and stages of change. In: Glanz K, Rimer BK, Viswanath K, editors. Health Behavior and Health Education: Theory, Research and Practice. 4 ed. San Francisco, CA: Jossey-Bass; 2008. p. 97-122.
Prochaska J, Prochaska J, Prochaska J. Building a science for multiple-risk behavior change. In: Riekert KA, Ockene JK, Pbert L, editors. The handbook of health behavior change. 4 ed. New York: Springer; 2014. p. 245-67.
Other Identifiers
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HHSN261201500015C
Identifier Type: -
Identifier Source: org_study_id
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