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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anne Lambert-Kerzner, VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier:
NCT01419418
First received: April 11, 2011
Last updated: January 22, 2016
Last verified: January 2016
History of Changes
  Purpose

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.

Condition
Peripheral Arterial Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of Patients' Perspectives of Factors That Support the Management of Cardiac Care for Improved Outcomes in a Peripheral Arterial Disease Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VA Eastern Colorado Health Care System:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.
Estimated Enrollment: 24
Study Start Date: January 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Peripheral Arterial Disease (PAD)
This is a longitudinal observational study. There were no interventions administered.

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419418

Locations
United States, Colorado
VA ECHCS
Denver, Colorado, United States, 80220
Sponsors and Collaborators
VA Eastern Colorado Health Care System
Investigators
Principal Investigator: Anne C Lambert-Kerzner, PhD, MSPH VAMC in Denver, Co.
Study Director: Thomas Tsai, MD VAMC Denver, Co.
  More Information

Responsible Party: Anne Lambert-Kerzner, Health Services Researcher, VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier: NCT01419418     History of Changes
Other Study ID Numbers: 10-1361 
Study First Received: April 11, 2011
Last Updated: January 22, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Eastern Colorado Health Care System:
Peripheral Arterial Disease (PAD)
Qualitative analysis
Patients' perspective

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 26, 2016