Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01134887
First received: May 28, 2010
Last updated: November 14, 2014
Last verified: November 2014

May 28, 2010
November 14, 2014
August 2010
September 2011   (final data collection date for primary outcome measure)
self-management of hypertension [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01134887 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Controlling Hypertension Outcomes by Improved Communication & Engagement
Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)

This randomized control study tested the feasibility of two communication enhancement interventions: one with veterans who had a stroke and demonstrated poorly controlled hypertension; the other with VA primary care providers who provided routine outpatient medical care to these veterans. This study intervened with both members of the provider-patient dyad in an attempt to improve the self-management of hypertension by improving communication during visits to the VA outpatient clinic, specifically by enabling veterans to communicate their questions and concerns about chronic disease self-management to their providers more effectively, and to help providers improve their ability to communicate more effectively with this population of veterans.

The communication intervention had two goals; (a) coaching to enhance veteran's abilities to communicate their questions and concerns about self-management for hypertension to their physician; and (b) improving provider's communication skills for enhancing and encouraging self-management of hypertension.

A health educator met with each participating veteran in the intervention arm prior to the 2nd visit to develop a plan for enhancing communication about self-management of hypertension.

The PI provided the Four Habits communication training to the 5 primary care providers in the intervention arm. Two clinic visits between each participating provider-patient pair were videotaped and coded.

This proposed project enrolled 10 VA primary care providers to participate in the randomized control trial and 30 veterans (3 veterans from the panel of each of the 10 participating providers) who had a stroke and now demonstrated poorly controlled hypertension. The study evaluated the difference between the two groups, and compared the content of the provider-patient conversations around hypertension management.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Hypertension
  • Stroke
Behavioral: Four Habits Model
The providers randomized to the intervention arm received training in Habit 1 of the Four Habits Model.
  • Experimental: Arm 1

    A health educator met with each participating veteran in the intervention arm prior to the 2nd visit to develop a plan for enhancing communication about self-management of hypertension.

    The PI provided the Four Habits communication training to the 5 primary care providers in the intervention arm. Two clinic visits between each participating provider-patient pair were videotaped and coded.

    Intervention: Behavioral: Four Habits Model
  • No Intervention: Arm 2
    Two clinic visits between each participating provider-patient pair were videotaped and coded.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Veteran:

  • Veteran is a patient of the enrolled provider
  • History of prior stroke
  • Poorly controlled hypertension with at least one measurement >140/90 mm Hg in the past 12 months
  • Complete a 6-item screen for cognitive and language impairment with a score of 3 or higher
  • Sign the VA Media consent for use of picture and/or voice

Provider:

  • Primary care provider, Medicine Service
  • Sign VA media consent for use of picture and/or voice

Exclusion Criteria:

  • Life expectancy is less than 6 months
  • Non-English language patients
  • Inability to provide informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01134887
RRP 09-190
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Richard M. Frankel, PhD Richard Roudebush VA Medical Center
Department of Veterans Affairs
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP