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Patients' Perspectives of Factors That Support the Management of Peripheral Arterial Disease for Improved Outcomes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by VA Eastern Colorado Health Care System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier:
NCT01419418
First received: April 11, 2011
Last updated: August 17, 2011
Last verified: April 2011

April 11, 2011
August 17, 2011
January 2011
January 2013   (final data collection date for primary outcome measure)
Patients' perspective of the factors that affects their decisions regarding management of their PAD [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Qualitative interview that will collect patients perspectives and will be analyzed for thoughts, opinions, feelings, and concepts.
Same as current
Complete list of historical versions of study NCT01419418 on ClinicalTrials.gov Archive Site
  • Quantitative Morinsky's Medication adherence survey [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Morinsky's Medication adherence survey will be administered at baseline and one year to assess self report medication adherence.
  • Quantitative PAQ health status survey [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    PAQ health status will be administered at the initial visit as well as the last one-on-one interview to assess disease specific health status.
  • Quantitative EQ-5D health status survey [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    survey will be administered at the initial visit as well as the last one-on-one interview to assess overall health status.
  • Quantitative Stage of Change Survey [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Stage of Change motivational survey will be administered at the initial visit as well as the last one-on-one interview to assess patients motivational status.
  • Quantitative SEAMS survey [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    SEAMS self efficacy survey will be administered at the initial visit as well as the last one-on-one interview to assess patient self efficacy to adhere to medication treatment.
Same as current
Not Provided
Not Provided
 
Patients' Perspectives of Factors That Support the Management of Peripheral Arterial Disease for Improved Outcomes
A Study of Patients' Perspectives of Factors That Support the Management of Cardiac Care for Improved Outcomes in a Peripheral Arterial Disease Population

Specific Aims: To delve into the complex phenomena of living with Peripheral Arterial Disease (PAD), and to investigate the patients' perspective of the factors that affects their decisions regarding management of their PAD.

a) Utilize a qualitative approach to uncover factors that patients perceive support the management of their condition utilizing a purposive sampling of Peripheral Arterial Disease patients.

  1. To determine what they believe to be effective tools to support themselves to improve their condition.
  2. To determine from the patient's perspective if adherence to prescribed medical regimes are important for them to improve their PAD outcomes.
  3. To describe the patient factors of those who are self reported adherent compared to those who are not or unable to their prescribed regimen.

Cardiovascular Diseases (CVD) affects as many lives each year as cancer, chronic lower respiratory diseases, accidents and diabetes mellitus combined. One in three American adults (about 80,000,000) has one or more types of cardiovascular disease. Prevention and management of CVD is a public health goal, yet, it remains a major challenge. Even hypertension, which is easily detected and usually controllable, has only a 50 percent control rate.

Peripheral Arterial Disease (PAD) is one type of CVD, which affects about eight million Americans and is also associated with significant morbidity and mortality. PAD increases with age and disproportionately affects African Americans. Interestingly, despite its prevalence and cardiovascular risk implications, only 20 to 30 percent of PAD patients are undergoing treatment.

Medical management of these diseases has substantially contributed to improved morbidity and mortality. However, for the medical therapies to be successful the patients need to take their medications and adjust their lifestyles, as prescribed. Overall, "typical adherence rates for the general population are about 50 percent for medications and are much lower for lifestyle prescriptions and other more behaviorally demanding regimens". Few studies have investigated the reactions and thoughts regarding the efficacy of therapies/interventions from the perspective of the participants. Meta analyses on adherence have also revealed that the patients' perspectives are often absent and that present adherence theories are more successful in explaining non-adherence than improving adherence. Therefore, it is important to understand, from the perspective of the patient; the factors they believe improve their cardiac outcomes with an emphasis on the adherence to prescribed therapies.

This qualitative study will investigate the question: What are patients' perspectives of factors that support the management of their cardiovascular condition to improve outcomes in a Peripheral Arterial Disease population? Cardiac outcomes of interest are health status defined by symptom burden, functional status, and health related quality of life, patients' perception of the quality of care that they receive, and the experience of living with PAD.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

A purposive sampling technique, meaning the sample will be selected according to the participant's diagnosis of the specific disease, will be utilized to enroll up to 24 Peripheral Arterial Disease patients from the VA Peripheral Arterial Disease clinic.

Peripheral Arterial Diseases
Not Provided
Peripheral Arterial Disease (PAD)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
January 2014
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Diagnosis of Peripheral Arterial Disease

Exclusion Criteria:

Unable to converse about the topic under investigation for up to one hour for multiple visits

Pregnancy

Both
18 Years to 89 Years
No
Contact: Anne C Lambert-Kerzner, MSPH, PhDc 303-370-7596 anne.lambert-kerzner@va.gov
United States
 
NCT01419418
10-1361
No
Anne Lambert-Kerzner, MSPH and Thomas Tsai, MD, MSc, VA ECHCS
VA Eastern Colorado Health Care System
Not Provided
Principal Investigator: Anne C Lambert-Kerzner, MSPH VAMC in Denver, Co.
Study Director: Thomas Tsai, MD VAMC Denver, Co.
VA Eastern Colorado Health Care System
April 2011

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