NCT01411956

Brief Summary

Researchers have linked media messages such as television programs to multiple problematic health behaviors. The narrative style of many television programs-involving a plot, recurrent characters, entertaining situations, and familiar settings-makes them compelling and likely contributes to the powerful influence these programs can have on behavior. However, narrative messages are not frequently utilized for prosocial purposes. In particular, health education embedded in a narrative context has been neither commonly utilized nor carefully evaluated. Using constructs from two complementary theories of health behavior, family physicians in a large metropolitan region have developed a situation comedy entitled "White Coats" that aims to provide quality patient education. The program currently airs on a local public access channel. The objective of this project is to evaluate the effect of one particular episode of "White Coats" on patient beliefs regarding hypertension.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
Last Updated

August 8, 2011

Status Verified

August 1, 2011

Enrollment Period

3 months

First QC Date

July 27, 2011

Last Update Submit

August 5, 2011

Conditions

Keywords

Health Behavior TheoryPatient EducationHypertensionHealth beliefs related to hypertension and hypertension treatment

Outcome Measures

Primary Outcomes (5)

  • Change in Likert scale agreement with Perceived severity questionnaire statement from immediately pre-intervention to immediately post-intervention and also 2 months post-intervention

    Participants ranked their agreement with the following statement on an 8-point Likert scale: "If you have high blood pressure, controlling your blood pressure is important."

    immediately pre-intervention, immediately post-intervention, and 2 months post-intervention

  • Change in Likert scale agreement with Perceived susceptibility questionnaire statement from immediately pre-intervention to immediately post-intervention and also 2 months post-intervention

    Participants ranked their agreement with the following statement on an 8-point Likert scale: "People don't need to worry about having high blood pressure if they don't have any symptoms (like headaches, chest pain, or blurry vision)."

    immediately pre-intervention, immediately post-intervention, and 2 months post-intervention

  • Change in Likert scale agreement with Perceived barriers to change questionnaire statement from immediately pre-intervention to immediately post-intervention and also 2 months post-intervention

    Participants ranked their agreement with the following statement on an 8-point Likert scale: "I can find time to exercise."

    immediately pre-intervention, immediately post-intervention, and 2 months post-intervention

  • Change in Likert scale agreement with self-efficacy questionnaire statement from immediately pre-intervention to immediately post-intervention and also 2 months post-intervention

    Participants ranked their agreement with the following statement on an 8-point Likert scale: "I can read food labels to look for high salt foods when I buy groceries."

    immediately pre-intervention, immediately post-intervention, and 2 months post-intervention

  • Change in Likert scale agreement with Outcome efficacy questionnaire statement from immediately pre-intervention to immediately post-intervention and also 2 months post-intervention

    Participants ranked their agreement with the following statement on an 8-point Likert scale: "If you have high blood pressure and take your medicines, you can lower your chance of having a heart attack."

    immediately pre-intervention, immediately post-intervention, and 2 months post-intervention

Study Arms (2)

Treatment Group

EXPERIMENTAL

This group viewed the intervention video, a 24-minute episode of the sitcom "White Coats," deliberately scripted with the five health behavior theory constructs we are testing.

Other: 24-minute video episode of patient education TV sitcom "White Coats"

Control Group

PLACEBO COMPARATOR

The control group viewed a 25-minute video on an unrelated subject (depression).

Other: Placebo video

Interventions

The series features a fictional married couple of Family Medicine physicians who work in the same practice, located in our community. In both their professional and private lives and, in moments both humorous and serious, these doctors teach patients about a wide variety of health topics. The intervention episode addressing hypertension will focus on three different patient-physician plot lines, which were developed to specifically address each of the beliefs about hypertension highlighted in the theoretical model (susceptibility, seriousness, barriers, self-efficacy and outcome efficacy.).

Treatment Group

The control group watched a 25-minute patient education video on depression.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ever told by a physician that you have hypertension
  • family history of hypertension
  • current stress
  • BMI over 30
  • current smoker
  • inactive/sedentary lifestyle (defined as less than 150 minutes of exercise a week)

You may not qualify if:

  • age under 18 or over 65

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Jennifer L Middleton, MD MPH FAAFP

    University of Pittsburgh Department of Family Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2011

First Posted

August 8, 2011

Study Start

October 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 8, 2011

Record last verified: 2011-08