Pro-Change Population Health Solution

NCT02755636 | Unknown Phase 2 DMC

• 1 other identifier: HHSN261201500015C
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with co-occurring health risk behaviors suffer greater morbidity, disability, and premature death. The Pro-Change Population Health Solution (PCPHS) is a suite of mobile tools designed to assist patients and primary care providers (PCPs) in applying evidence-based principles of health behavior change to reduce four cancer risk behaviors-cigarette smoking, risky drinking, noncompliance with national guidelines for physical activity, and overweight and obesity-and depression among at-risk patients. The intervention is based on the Transtheoretical Model of Behavior Change (TTM, the "stage model") and includes computer-tailored interventions and text messages for patients and a clinical dashboard for providers. The efficacy of the intervention will be assessed in a cluster-randomized trial involving 780 patients recruited from 12 federally qualified health centers randomly assigned to intervention or usual care.

Conditions

Risk Behavior

Keywords

Health Behavior Change; Primary Health Care; Patient Participation; Provider-Patient Communication; Cluster-Randomized Trial; Mobile Health

Outcome Measures

Primary Outcomes (1)

• Change in number of cancer risk behaviors

  Change in number of cancer risk behaviors will be computed by taking the difference in the count of the four cancer risk behaviors (cigarette smoking, risky drinking, noncompliance with national guidelines for physical activity, and overweight and obesity) from baseline to 12 months follow-up. At each time point, the index will range from 0 to 4, with each risk behavior scored a "1" if present, and "0" if not present (Prochaska, Prochaska, \& Prochaska, 2014).

  Baseline, 12 months

Secondary Outcomes (5)

• Change in consumer engagement

  Baseline, 12 months

• Adherence with cancer screenings

  12 months

• Change in satisfaction with medical care

  Baseline, 12 months

• Change in well-being

  Baseline, 12 months

• Change in health-related quality of life

  Baseline, 12 months

Other Outcomes (10)

• Change in number of cigarettes smoked per day

  Baseline, 12 months

• Progress to the Action stage for smoking cessation

  12 months

• Change in number of alcoholic drinks per week

  Baseline, 12 months

Study Arms (2)

PCPHC intervention

EXPERIMENTAL

PCPHC intervention during 6-month intervention period plus study assessments at baseline, 6, and 12 months

Behavioral: PCPHC; Other: Usual care

Usual care

ACTIVE COMPARATOR

Usual primary care plus study assessments at baseline, 6, and 12 months

Other: Usual care

Interventions

PCPHC BEHAVIORAL

Mobile-delivered health risk intervention (HRI), computer-tailored interventions (CTIs), text messages; provider-delivered one-on-one session guided by clinical dashboard

PCPHC intervention

Usual care OTHER

Primary care as usual

PCPHC intervention; Usual care

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has at least one of the following behavioral risk factors for cancer:
• Cigarette smoker
• Exceeds recommended limits for alcohol intake
• Does not meet national guidelines for physical activity
• Overweight or obese

You may not qualify if:

• Currently pregnant
• Currently undergoing cancer treatment
• Serious medical condition that could prevent participation in the study for a full year
• History of mania, schizophrenia, or other psychoses
• Admitted to an inpatient mental health facility within the previous 2 years
• Currently enrolled in the In It to Quit Study at the Community Health Center, Inc.
• Unable to read English or Spanish
• 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.

Sponsors & Collaborators

• Pro-Change Behavior Systems: lead
• Community Health Center, Inc.: collaborator

Study Sites (2)

Connecticut Health Center, Inc.

Middletown, Connecticut, 06457, United States

RECRUITING

Pro-Change Behavior Systems, Inc.

South Kingstown, Rhode Island, 02879, United States

RECRUITING

Related Publications (10)

• Agency for Healthcare Policy and Research. CAHPS 2.0 survey and reporting kit. Rockville, MD: Agency for Healthcare Policy and Research; 1999.

  BACKGROUND

• Cantril H. The pattern of human concerns. New Brunswick, NJ: Rutgers University Press; 1965.

  BACKGROUND

• Centers for Disease Control and Prevention. Measuring Healthy Days: Population Assessment of Health-Related Quality of Life. Atlanta, GA; 2000.

  BACKGROUND

• 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.

  PMID: 26097010 BACKGROUND

• 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.

  PMID: 4053261 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 14727785 BACKGROUND

• 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.

  PMID: 18752852 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Risk-Taking; Patient Participation

Condition Hierarchy (Ancestors)

Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Deborah A Levesque, Ph.D.

  Pro-Change Behavior Systems

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah A Levesque, Ph.D

CONTACT

401-360-2975; dlevesque@prochange.com

Deborah Van Marter, M.P.H.

CONTACT

401-360-2981; dvanmarter@prochange.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Science Officer

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 29, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: June 2, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)