Peripheral Arterial DiseasesNCT01419418
Patients' Perspectives of Factors That Support the Management of Peripheral Arterial Disease for Improved Outcomes
An observational study of Peripheral Arterial Diseases, run by VA Eastern Colorado Health Care System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Peripheral Arterial Diseases
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of Peripheral Arterial Disease
Who cannot join
- Unable to converse about the topic under investigation for up to one hour for multiple visits
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- 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.
- To determine what they believe to be effective tools to support themselves to improve their condition.
- To determine from the patient's perspective if adherence to prescribed medical regimes are important for them to improve their PAD outcomes.
- To describe the patient factors of those who are self reported adherent compared to those who are not or unable to their prescribed regimen.
Read the 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.
- Conditions
- Peripheral Arterial Diseases
- Keywords
- Peripheral Arterial Disease (PAD), Qualitative analysis, Patients' perspective
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Arterial Disease (PAD) | This is a longitudinal observational study. There were no interventions administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Anne Lambert-Kerzner, VA Eastern Colorado Health Care System
- Investigators
- Anne C Lambert-Kerzner, PhD, MSPH, Principal investigator, VAMC in Denver, Co.Thomas Tsai, MD, Study director, VAMC Denver, Co.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419418
- Sponsor's protocol ID
- 10-1361
- Status last verified
- May 2017
- First submitted
- 11 Apr 2011
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01419418
- Acronym / sponsor ID
- 10-1361
- Conditions
- Peripheral Arterial Diseases
- Keywords
- Peripheral Arterial Disease (PAD), Qualitative analysis, Patients' perspective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Study start
- Jan 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- To determine what they believe to be effective tools to support themselves to improve their condition.
- To determine from the patient's perspective if adherence to prescribed medical regimes are important for them to improve their PAD outcomes.
- To describe the patient factors of those who are self reported adherent compared to those who are not or unable to their prescribed regimen.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral Arterial Disease (PAD) | – | –This is a longitudinal observational study. There were no interventions administered. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Diagnosis of Peripheral Arterial Disease
Key exclusion criteria (2 listed)
- Unable to converse about the topic under investigation for up to one hour for multiple visits
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients' perspective of the factors that affects their decisions regarding management of their PAD
Time frame: 1 year
Qualitative interview that will collect patients perspectives and will be analyzed for thoughts, opinions, feelings, and concepts.
5 secondary outcomes
Quantitative Morinsky's Medication adherence survey
Time frame: 1 year
Quantitative PAQ health status survey
Time frame: 1 year
Quantitative EQ-5D health status survey
Time frame: 1 year
Quantitative Stage of Change Survey
Time frame: 1 year
Quantitative SEAMS survey
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne C Lambert-Kerzner, PhD, MSPH principal investigator
VAMC in Denver, Co.
Thomas Tsai, MD study director
VAMC Denver, Co.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Diseases, run by VA Eastern Colorado Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' perspective of the factors that affects their decisions regarding management of their PAD (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.