NCT00404027

Brief Summary

The purpose of this research study is to assess patient and provider attitudes towards the role that patients should play in medical decision making and self-management. We will examine the degree to which similarity of attitudes held by VA patients being treated for co-morbid diabetes mellitus and hypertension and by their primary care providers is a determinant of patient satisfaction, patient adherence, and adequacy of blood pressure and diabetic control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

June 4, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

3.3 years

First QC Date

November 22, 2006

Last Update Submit

June 2, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • PPOS scores

    Patient-Practitioner Orientation Scale: degree of symmetry between patient and provider regarding patient-centeredness

    same day as appointment with provider

Secondary Outcomes (2)

  • Blood pressure

    Same day as appointment with provider

  • Hemoglobin A1c

    Same day as appointment with provider

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Veteran primary care patients

You may qualify if:

  • Patients enrolled in primary care clinics at the study sites (Iowa City VAMC, Jesse Brown VAMC - Chicago) who are scheduled to be seen by a participating provider in the next three (3) months and have been seen on at least three (3) additional occasions by that same
  • provider in the prior 24 months. Participating patients must also:
  • i) have prior diagnoses of both HTN and DM, as documented in VA administrative files;
  • ii) have an active prescription for an anti-hypertensive medication in the following medication classes: thiazide diuretic, beta blocker, angiotensin converting enzyme (ACE) inhibitor, angiotensin receptor blocker (ARB), calcium channel blocker, or alpha blocker;
  • iii) have an active prescription for an oral hypoglycemic agent or for an insulin preparation;
  • iv) be able to provide informed consent;
  • v) have a home telephone; and
  • vi) reside in an independent living environment and not in a skilled care facility.

You may not qualify if:

  • i) cognitive impairment;
  • ii) severe underlying illness, including: metastatic cancer, active treatment for any malignancy (excluding basal and squamous cell skin cancers), end-stage renal disease, cirrhosis, severe chronic obstructive lung disease requiring home oxygen therapy, and congestive
  • heart failure with a documented left ventricular ejection fraction of less than 35% or a prior echocardiogram denoting "severe" left ventricular dysfunction; and
  • iii) visits in the prior 18 months to a VA endocrinology, cardiology, or nephrology clinic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

Related Publications (6)

  • Baldwin AS, Vander Weg MW, Christensen AJ, Rothman AJ. Examining the Causal Mechanisms Underlying Self-generated Arguments for Health Behavior Change. [Abstract]. Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2009 Apr 1; 37(S):229.

    RESULT
  • Cvengros JA, Christensen AJ, Hillis SL, Rosenthal GE. Patient and physician attitudes in the health care context: attitudinal symmetry predicts patient satisfaction and adherence. Ann Behav Med. 2007 Jun;33(3):262-8. doi: 10.1007/BF02879908.

  • Baldwin AS, Cvengros JA, Christensen AJ, Ishani A, Kaboli PJ. Preferences for a patient-centered role orientation: association with patient-information-seeking behavior and clinical markers of health. Ann Behav Med. 2008 Feb;35(1):80-6. doi: 10.1007/s12160-007-9011-x.

  • Cvengros JA, Christensen AJ, Cunningham C, Hillis SL, Kaboli PJ. Patient preference for and reports of provider behavior: impact of symmetry on patient outcomes. Health Psychol. 2009 Nov;28(6):660-7. doi: 10.1037/a0016087.

  • Howren MB, Christensen AJ, Karnell LH, Funk GF. Health-related quality of life in head and neck cancer survivors: impact of pretreatment depressive symptoms. Health Psychol. 2010 Jan;29(1):65-71. doi: 10.1037/a0017788.

  • Christensen AJ, Howren MB, Hillis SL, Kaboli P, Carter BL, Cvengros JA, Wallston KA, Rosenthal GE. Patient and physician beliefs about control over health: association of symmetrical beliefs with medication regimen adherence. J Gen Intern Med. 2010 May;25(5):397-402. doi: 10.1007/s11606-010-1249-5. Epub 2010 Feb 20.

MeSH Terms

Conditions

Diabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Alan J. Christensen, PhD

    Iowa City VA Health Care System, Iowa City, IA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2006

First Posted

November 27, 2006

Study Start

June 4, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations