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

Peripheral Arterial Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419418
• Other study ID #: 10-1361
• Status: Completed
• Phase: N/A
• First received: April 11, 2011
• Last updated: May 22, 2017
• Start date: January 2011
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: VA Eastern Colorado Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Arterial Diseases
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
United States	VA ECHCS	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VA Eastern Colorado Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' perspective of the factors that affects their decisions regarding management of their PAD	Qualitative interview that will collect patients perspectives and will be analyzed for thoughts, opinions, feelings, and concepts.	1 year
Secondary	Quantitative Morinsky's Medication adherence survey	Morinsky's Medication adherence survey will be administered at baseline and one year to assess self report medication adherence.	1 year
Secondary	Quantitative PAQ health status survey	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.	1 year
Secondary	Quantitative EQ-5D health status survey	survey will be administered at the initial visit as well as the last one-on-one interview to assess overall health status.	1 year
Secondary	Quantitative Stage of Change Survey	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.	1 year
Secondary	Quantitative SEAMS survey	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.	1 year