Using Stories to Address Disparities in Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01276197
First received: January 11, 2011
Last updated: October 21, 2016
Last verified: October 2016
Results First Received: June 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Health Services Research
Condition: Hypertension
Interventions: Other: Story-Telling DVD
Other: Non-Storytelling DVD

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1: Story-Telling DVD

Participant will receive a DVD with informational and story-telling components

Story-Telling DVD: DVD will contain both informational and story-telling components.

Arm 2: Non-Storytelling DVD

Participant will receive an informational DVD

Non-Storytelling DVD: DVD will contain only informational component.


Participant Flow:   Overall Study
    Arm 1: Story-Telling DVD   Arm 2: Non-Storytelling DVD
STARTED   308   310 
COMPLETED   200   200 
NOT COMPLETED   108   110 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1: Story-Telling DVD

Participant will receive a DVD with informational and story-telling components

Story-Telling DVD: DVD will contain both informational and story-telling components.

Arm 2: Non-Storytelling DVD

Participant will receive an informational DVD

Non-Storytelling DVD: DVD will contain only informational component.

Total Total of all reporting groups

Baseline Measures
   Arm 1: Story-Telling DVD   Arm 2: Non-Storytelling DVD   Total 
Overall Participants Analyzed 
[Units: Participants]
 308   310   618 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   190   186   376 
>=65 years   118   124   242 
Gender 
[Units: Participants]
     
Female   26   25   51 
Male   282   285   567 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   308   310   618 
White   0   0   0 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 


  Outcome Measures
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1.  Primary:   Systolic BP at Follow-up   [ Time Frame: 6 months after intervention ]

2.  Primary:   Diastolic BP Measurement at Follow-up   [ Time Frame: 6-month following intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our multi-site trial was limited by challenges in recruitment (lower enrollment at one site) that resulted in overall recruitment lower than planned. Further, we did have some loss to follow-up.