Heart Failure, CongestiveEarly Phase 1NCT00645489
A Family Intervention for Improving Self-Care of Patients With Heart Failure
A Early Phase 1 study testing psychoeducational and wait list in people with Heart Failure, Congestive, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This is a pilot study of a family-based educational program for patients with heart failure, and their family members. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- psychoeducational and wait list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2009
- Phase
- Early Phase 1
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage C Heart Failure,[34] which refers to past or current symptoms of heart failure with underlying structural heart disease. Indicated by chronic systolic dysfunction (left ventricle [LV] ejection fraction < 45%), diastolic dysfunction (with echo evidence of diminished compliance of the LV), or both.
- The patient's cardiologist has recommended or initiated one of the following to prevent decompensation: continuing diuretic treatment, fluid restrictions, and/or restriction/reduction of dietary sodium intake.
- A family member or members available for study participation with whom patient lives for at least 5 days a week. Emphasis will be given to the closest family members available (i.e., spouse).
- Subjects are able to give informed consent (see below for exclusion due to well-documented dementia or evidence of cognitive impairment).
- Patients will be age 50 or above. Younger patients may have a different family environment than the most common type of patient who is the target of the FPI intervention.
Who cannot join
- Patient has a well-documented diagnosis of dementia
- Moderate or greater cognitive impairment, based on the Blessed Test of Orientation, Memory, and Concentration (BOMC)[26] score of 16.
- Patient's family member has BOMC score of 10 (i.e., mild or greater cognitive impairment).
- Inability to communicate verbally, major visual impairment, uncorrected hearing loss.
- Patient and/or family member reports "frequent use" illicit substance abuse within the past year. Scores on the AUDIT-C 4 indicating alcohol abuse/dependence.[30]
- Patient or family member has a current diagnosis of schizophrenia spectrum psychiatric disorder (e.g., schizophrenia, schizoaffective disorder).
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- Patient indicates active suicidal ideation and evaluated as a clinical risk.
- Patient is in the Philadelphia VAMC home-telehealth program or some other incompatible intervention.
- Patient has an unstable medical condition that would likely prevent the subject from completing the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
This is a pilot study of a family-based educational program for patients with heart failure, and their family members.
Read the detailed description
- Objectives(s): We plan to conduct a feasibility pilot trial of the Family Partnership Intervention (FPI) compared to patients in the HF Wait-list (WL) condition. We plan to demonstrate feasibility, estimate variances of major outcome variables, and to obtain preliminary estimates of effect sizes in preparation for subsequent grant applications. We will be able to develop a cost-effectiveness model for the relative benefit of FPI vs. no family-based for use in longer-term studies.
- Research Design: This is a short-term, randomized clinical trial which will involve assessments for participants in the FPI condition at a pre-intervention Baseline point, immediately post-intervention, and 6 months post-intervention. Participants in the WL condition will be assessed at Baseline, undergo an approximately 8 week waiting period, and then the FPI. A longer follow-up is not planned based on the purpose of this study as a feasibility trial.
- Methodology: We plan to randomize 40 Veterans and their family members to either the FPI condition or WL condition, in equal proportions. We will recruit patients with at least Stage C Heart Failure (NYHA class I - IV) from the Cardiology clinic of the Philadelphia VAMC. FPI will involve 4-6 hours of intervention delivered over a period of 6-8 weeks. Assessments at a pre-treatment baseline point, 8 weeks (immediately post-treatment), and 6 months will cover the following domains: a) patients' demographic characteristics and clinical functioning, b) self-care, including self-management of symptoms, knowledge of HF, and adherence to medication and dietary intake of sodium, c) measures of family functioning relevant to the medical care of the patient, and d) health care utilization costs. Primary outcome measures will be patients' self-reported HF self-care and health care utilization costs. We anticipate that patients in the FPI condition will exhibit better self-care over time compared to patients in the WL condition. We also anticipate that patients and family members will exhibit an improved family environment and better HF knowledge.
- Conditions
- Heart Failure, Congestive
- Being tested
- psychoeducational, wait list
- Keywords
- heart failure intervention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducationalBehavioural
Psychoeducation intervention includes information about self-care of heart failure, and a communication training intervention for patients and family members
wait listOther
Wait list
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Control condition is wait-list control. Receives: Other: wait list |
| 2 | Experimental | Active treatment condition: psychoeducational intervention for patients with HF Receives: Behavioral: psychoeducational |
What is being measured
The primary outcome is the main question the study is designed to answer.
dietary sodium intake
Measured: 6 months
Secondary outcomes (1)
medication adherence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Steven L. Sayers, PhD, Principal investigator, VA Medical Center, Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645489
- Sponsor's protocol ID
- MIRECC002
- Other IDs
- 01008, 0008
- Status last verified
- Dec 2008
- First submitted
- 24 Mar 2008
- Last updated
- 6 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Family Intervention for Improving Self-Care of Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT00645489
- Acronym / sponsor ID
- MIRECC002
- Conditions
- Heart Failure, Congestive
- Keywords
- heart failure intervention
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 Mar 2008 (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.
This is a pilot study of a family-based educational program for patients with heart failure, and their family members.
Detailed description
- Objectives(s): We plan to conduct a feasibility pilot trial of the Family Partnership Intervention (FPI) compared to patients in the HF Wait-list (WL) condition. We plan to demonstrate feasibility, estimate variances of major outcome variables, and to obtain preliminary estimates of effect sizes in preparation for subsequent grant applications. We will be able to develop a cost-effectiveness model for the relative benefit of FPI vs. no family-based for use in longer-term studies.
- Research Design: This is a short-term, randomized clinical trial which will involve assessments for participants in the FPI condition at a pre-intervention Baseline point, immediately post-intervention, and 6 months post-intervention. Participants in the WL condition will be assessed at Baseline, undergo an approximately 8 week waiting period, and then the FPI. A longer follow-up is not planned based on the purpose of this study as a feasibility trial.
- Methodology: We plan to randomize 40 Veterans and their family members to either the FPI condition or WL condition, in equal proportions. We will recruit patients with at least Stage C Heart Failure (NYHA class I - IV) from the Cardiology clinic of the Philadelphia VAMC. FPI will involve 4-6 hours of intervention delivered over a period of 6-8 weeks. Assessments at a pre-treatment baseline point, 8 weeks (immediately post-treatment), and 6 months will cover the following domains: a) patients' demographic characteristics and clinical functioning, b) self-care, including self-management of symptoms, knowledge of HF, and adherence to medication and dietary intake of sodium, c) measures of family functioning relevant to the medical care of the patient, and d) health care utilization costs. Primary outcome measures will be patients' self-reported HF self-care and health care utilization costs. We anticipate that patients in the FPI condition will exhibit better self-care over time compared to patients in the WL condition. We also anticipate that patients and family members will exhibit an improved family environment and better HF knowledge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: wait listControl condition is wait-list control. |
| 2 | Experimental | Behavioral: psychoeducationalActive treatment condition: psychoeducational intervention for patients with HF |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stage C Heart Failure,[34] which refers to past or current symptoms of heart failure with underlying structural heart disease. Indicated by chronic systolic dysfunction (left ventricle [LV] ejection fraction < 45%), diastolic dysfunction (with echo evidence of diminished compliance of the LV), or both.
- The patient's cardiologist has recommended or initiated one of the following to prevent decompensation: continuing diuretic treatment, fluid restrictions, and/or restriction/reduction of dietary sodium intake.
- A family member or members available for study participation with whom patient lives for at least 5 days a week. Emphasis will be given to the closest family members available (i.e., spouse).
- Subjects are able to give informed consent (see below for exclusion due to well-documented dementia or evidence of cognitive impairment).
- Patients will be age 50 or above. Younger patients may have a different family environment than the most common type of patient who is the target of the FPI intervention.
Key exclusion criteria (9 listed)
- Patient has a well-documented diagnosis of dementia
- Moderate or greater cognitive impairment, based on the Blessed Test of Orientation, Memory, and Concentration (BOMC)[26] score of 16.
- Patient's family member has BOMC score of 10 (i.e., mild or greater cognitive impairment).
- Inability to communicate verbally, major visual impairment, uncorrected hearing loss.
- Patient and/or family member reports "frequent use" illicit substance abuse within the past year. Scores on the AUDIT-C 4 indicating alcohol abuse/dependence.[30]
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 |
|---|---|---|
| psychoeducationalPsychoeducation intervention includes information about self-care of heart failure, and a communication training intervention for patients and family members | Behavioural | 2 |
| wait listWait list | Other | 1 |
Primary outcome
dietary sodium intake
Time frame: 6 months
1 secondary outcome
medication adherence
Time frame: 6 months
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 6 Jan 2010.
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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.
Steven L. Sayers, PhD principal investigator
VA Medical Center, Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing psychoeducational and wait list in people with Heart Failure, Congestive, run by US Department of Veterans Affairs 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 5 inclusion and 9 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 6 Jan 2010. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
dietary sodium intake (time frame: 6 months). 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 6 Jan 2010.