NCT01419418

Brief 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. 1.To determine what they believe to be effective tools to support themselves to improve their condition.
  2. 2.To determine from the patient's perspective if adherence to prescribed medical regimes are important for them to improve their PAD outcomes.
  3. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 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

Study Start

First participant enrolled

January 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 18, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

5.9 years

First QC Date

April 11, 2011

Last Update Submit

May 22, 2017

Conditions

Keywords

Peripheral Arterial Disease (PAD)Qualitative analysisPatients' perspective

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Quantitative Morinsky's Medication adherence survey

    1 year

  • Quantitative PAQ health status survey

    1 year

  • Quantitative EQ-5D health status survey

    1 year

  • Quantitative Stage of Change Survey

    1 year

  • Quantitative SEAMS survey

    1 year

Study Arms (1)

Peripheral Arterial Disease (PAD)

This is a longitudinal observational study. There were no interventions administered.

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Diagnosis of Peripheral Arterial Disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA ECHCS

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Anne C Lambert-Kerzner, PhD, MSPH

    VAMC in Denver, Co.

    PRINCIPAL INVESTIGATOR
  • Thomas Tsai, MD

    VAMC Denver, Co.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Health Services Researcher

Study Record Dates

First Submitted

April 11, 2011

First Posted

August 18, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 23, 2017

Record last verified: 2017-05

Locations