Congestive Heart FailureNCT00178009
Developing and Assessing Competencies for Caregivers and Patients With Ventricular Assist Devices
An observational study of Congestive Heart Failure, run by University of Pittsburgh at 1 site in United States.
Trial summary
Discharge to the community is increasingly becoming a priority for patients implanted with a Ventricular Assist Device (VAD). Because VADs are complex, patients and caregivers often fear leaving the hospital, although their status does not require hospitalization. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- self-paced instruction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jun 2008
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Four males; 4 females. Mean age of 39.6 (age range = 26-67) Caucasian = 100%
Who may be able to join
- Patient and Caregiver Phase: The inclusion criteria are: (1) patients implanted with a VAD and identified by a member of the AHP team to undergo training prior to discharge (2) informal caregiver of a patient implanted with a VAD and identified by a member of the AHP team to undergo training (3) are between 18 to 95 years of age. No exclusion criteria shall be based on race, ethnicity, gender, or HIV status.
- Health Professional Phase: The inclusion criteria are: (1) A licensed health-care professional (2) currently employed at UPMC No exclusion criteria shall be based on race, ethnicity, gender, or HIV status.
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Developing and Assessing Competencies for Patients, Caregivers and Health Professionals for the Care of Patients Implanted With Ventricular Assist Devices
Discharge to the community is increasingly becoming a priority for patients implanted with a Ventricular Assist Device (VAD). Because VADs are complex, patients and caregivers often fear leaving the hospital, although their status does not require hospitalization. This project includes development of CD/video and web-based instructional programs on management of the VAD controller for patients and their caregivers (formal and informal). A clinical trial will be used to examine discharge rates and placements following patients educated under usual care vs. self-pace CD/video conditions.
Read the detailed description
Discharge to the community is increasingly becoming a priority for patients implanted with a Ventricular Assist Device (VAD). The current study is designed to develop an Artificial Heart Continuity of Care Competency Program (AHC3P) to ensure the safety and feasibility of their return to the community. This program will identify and delineate the step-by-step procedures required to care for a patient's ventricular assist device (VAD) on a daily basis, or during an emergency. These step-by-step procedures will be will be used to develop a self-paced learning CD/video program for patients and caregivers and competencies. The same competencies will also be used by the Artificial Heart Program team to assess caregiver skills, and provide direct feedback on steps that need revision or more in-depth instruction. Subjects will be recruited in four phases. Training for all four phases will be conducted by members of the AHP team. During Phase I, VAD recipients will be videotaped while undergoing the current Artificial Heart Program (AHP) training. During Phase II, VAD recipients and their caregivers will be recruited as the control group and will also undergo the current AHP training. Phase III will involve patients and their informal caregivers undergoing the AHC3P and will serve as the experimental group. Data regarding the self-efficacy of the trainees and the length of time and the number of trials required to achieve competency with the AHC3P will be compared to the training program currently in place. During the fourth phase, health care professionals from UPMC will be recruited to undergo the AHC3P training. Data regarding their self-efficacy prior to and after the training program will be compared.
- Conditions
- Congestive Heart Failure
- Being tested
- self-paced instruction
- Keywords
- computer-assisted instruction, instruction (video)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-paced instructionBehavioural
Patients and caregivers review a DVD as often as they wish on how to care for routine and emergency procedures associated with their artificial heart
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and caregiver competency scores
Measured: Upon discharge
Secondary outcomes (1)
Time and number of trials to competency for patients and caregivers.
Measured: Upon discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- The Greg Beckwith Foundation
- Investigators
- Margo B. Holm, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178009
- Sponsor's protocol ID
- 0403075
- Status last verified
- Feb 2011
- First submitted
- 13 Sep 2005
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Assessing Competencies for Patients, Caregivers and Health Professionals for the Care of Patients Implanted With Ventricular Assist Devices
- ClinicalTrials.gov ID
- NCT00178009
- Acronym / sponsor ID
- 0403075
- Conditions
- Congestive Heart Failure
- Keywords
- computer-assisted instruction, instruction (video)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- The Greg Beckwith Foundation
- Study start
- Jan 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 15 Sep 2005 (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.
Discharge to the community is increasingly becoming a priority for patients implanted with a Ventricular Assist Device (VAD). Because VADs are complex, patients and caregivers often fear leaving the hospital, although their status does not require hospitalization. This project includes development of CD/video and web-based instructional programs on management of the VAD controller for patients and their caregivers (formal and informal). A clinical trial will be used to examine discharge rates and placements following patients educated under usual care vs. self-pace CD/video conditions.
Detailed description
Discharge to the community is increasingly becoming a priority for patients implanted with a Ventricular Assist Device (VAD). The current study is designed to develop an Artificial Heart Continuity of Care Competency Program (AHC3P) to ensure the safety and feasibility of their return to the community. This program will identify and delineate the step-by-step procedures required to care for a patient's ventricular assist device (VAD) on a daily basis, or during an emergency. These step-by-step procedures will be will be used to develop a self-paced learning CD/video program for patients and caregivers and competencies. The same competencies will also be used by the Artificial Heart Program team to assess caregiver skills, and provide direct feedback on steps that need revision or more in-depth instruction. Subjects will be recruited in four phases. Training for all four phases will be conducted by members of the AHP team. During Phase I, VAD recipients will be videotaped while undergoing the current Artificial Heart Program (AHP) training. During Phase II, VAD recipients and their caregivers will be recruited as the control group and will also undergo the current AHP training. Phase III will involve patients and their informal caregivers undergoing the AHC3P and will serve as the experimental group. Data regarding the self-efficacy of the trainees and the length of time and the number of trials required to achieve competency with the AHC3P will be compared to the training program currently in place. During the fourth phase, health care professionals from UPMC will be recruited to undergo the AHC3P training. Data regarding their self-efficacy prior to and after the training program will be compared.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Four males; 4 females. Mean age of 39.6 (age range = 26-67) Caucasian = 100%
Key inclusion criteria (3 listed)
- Patient and Caregiver Phase: The inclusion criteria are: (1) patients implanted with a VAD and identified by a member of the AHP team to undergo training prior to discharge (2) informal caregiver of a patient implanted with a VAD and identified by a member of the AHP team to undergo training (3) are between 18 to 95 years of age. No exclusion criteria shall be based on race, ethnicity, gender, or HIV status.
- Health Professional Phase: The inclusion criteria are: (1) A licensed health-care professional (2) currently employed at UPMC No exclusion criteria shall be based on race, ethnicity, gender, or HIV status.
- -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-paced instructionPatients and caregivers review a DVD as often as they wish on how to care for routine and emergency procedures associated with their artificial heart | Behavioural | – |
Primary outcome
Patient and caregiver competency scores
Time frame: Upon discharge
1 secondary outcome
Time and number of trials to competency for patients and caregivers.
Time frame: Upon discharge
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 21 Feb 2011.
Related trials for Congestive Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
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.
Margo B. Holm, PhD principal investigator
University of Pittsburgh
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 Congestive Heart Failure, run by University of Pittsburgh 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 3 inclusion and 1 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 21 Feb 2011. 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?
Patient and caregiver competency scores (time frame: Upon discharge). 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 21 Feb 2011.