Heart FailurePhase 1/2NCT01894750
Building Skill in Heart Failure Self-care: A Community Based Intervention
A Phase 1/2 study testing group-based skill building self-care program in people with Heart Failure, run by NYU Langone Health at 2 sites in United States.
Trial summary
The purpose of this study is to pilot and feasibility test an innovative cognitive behavioral intervention to improve heart failure self-care among community dwelling older adults.The primary aim of this study is to test the effect of the intervention on improving heart failure self-care, knowledge and Health related… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- group-based skill building self-care program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to Sep 2014
- Phase
- Phase 1/2
- 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
- diagnosis of chronic HF
- able to read and speak English or Spanish
- over age 50
Who cannot join
- history of prior neurological event (e.g., stroke, head injury, encephalopathy) that could cause dementia
- unable to perform tests or participate in the intervention session (e.g., inability to communicate verbally, major visual impairment, or severe and uncorrected hearing loss).
- living in a nursing home or other long term care facility
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bellevue Hospital
New York, New York, 10010
NYU Langone Medical Center
New York, New York, 10010
About this study
Official title: Building Skill in Heart Failure Self-Care: A Community Based Intervention
The purpose of this study is to pilot and feasibility test an innovative cognitive behavioral intervention to improve heart failure self-care among community dwelling older adults.The primary aim of this study is to test the effect of the intervention on improving heart failure self-care, knowledge and Health related quality of life at 1 month and 3 months. We will test three hypotheses comparing 60 older adults with heart failure randomly assigned to either the intervention or a control group:
Hypothesis 1. Participants in the intervention group will have significantly improved heart failure self-care than control participants.
Read more
Hypothesis 2. Participants in the intervention group will have significantly improved knowledge about heart failure and heart failure self-care than control participants.
Hypothesis 3. Participants in the intervention group will have significantly better Health Related Quality of Life than control participants.
A secondary exploratory aim is to assess and describe implementation feasibility of providing a heart failure self-care intervention in a community group setting.
- Conditions
- Heart Failure
- Being tested
- group-based skill building self-care program
- Keywords
- Heart Failure, Self-Care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group-based skill building self-care programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| skill bulding Intevention | Experimental | group-based skill building self-care program Receives: Behavioral: group-based skill building self-care program |
| usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline heart failure self-care score at one month
Heart failure self-care is measured by the valid and reliable instrument the Self-Care of Heart Failure Index. Change in scores from baseline at one month will be assessed.
Measured: Change from baseline heart failure self-care at 1 month
Change in baseline heart failure self-care score at 3 months
Heart failure self-care is measured by the valid and reliable instrument the Self-Care of Heart Failure Index. Change in scores from baseline to 3 months will be assessed.
Measured: Change from baseline heart failure self-care at 3 months
Secondary outcomes (2)
Change in baseline Heart failure knowledge score at 1 month
Heart failure knowledge will be measured using the valid and reliable Dutch Heart Failure Knowledge survey. Changes in total score from baseline at 1 month will be assessed.
Measured: Change in baseline Heart failure knowledge score at 1 month
Change in baseline Heart failure knowledge score at 3 month
Heart failure knowledge will be measured using the valid and reliable Dutch Heart Failure Knowledge survey. Changes in total heart failure knowledge score from baseline to 3 months will be assessed.
Measured: Change in baseline Heart failure knowledge score at 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJun 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria Vaughan Dickson, PhD, RN, FAHA, Principal investigator, NYU College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894750
- Sponsor's protocol ID
- R10-02126
- Other IDs
- 10CRP4140049
- Status last verified
- Apr 2015
- First submitted
- 1 Jul 2013
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Skill in Heart Failure Self-Care: A Community Based Intervention
- ClinicalTrials.gov ID
- NCT01894750
- Acronym / sponsor ID
- R10-02126
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Self-Care
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Jul 2013 (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.
The purpose of this study is to pilot and feasibility test an innovative cognitive behavioral intervention to improve heart failure self-care among community dwelling older adults.The primary aim of this study is to test the effect of the intervention on improving heart failure self-care, knowledge and Health related quality of life at 1 month and 3 months. We will test three hypotheses comparing 60 older adults with heart failure randomly assigned to either the intervention or a control group:
Hypothesis 1. Participants in the intervention group will have significantly improved heart failure self-care than control participants.
Hypothesis 2. Participants in the intervention group will have significantly improved knowledge about heart failure and heart failure self-care than control participants.
Hypothesis 3. Participants in the intervention group will have significantly better Health Related Quality of Life than control participants.
A secondary exploratory aim is to assess and describe implementation feasibility of providing a heart failure self-care intervention in a community group setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| skill bulding Intevention | Experimental | Behavioral: group-based skill building self-care programgroup-based skill building self-care program |
| usual care | No intervention | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of chronic HF
- able to read and speak English or Spanish
- over age 50
Key exclusion criteria (3 listed)
- history of prior neurological event (e.g., stroke, head injury, encephalopathy) that could cause dementia
- unable to perform tests or participate in the intervention session (e.g., inability to communicate verbally, major visual impairment, or severe and uncorrected hearing loss).
- living in a nursing home or other long term care facility
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 |
|---|---|---|
| group-based skill building self-care program | Behavioural | skill bulding Intevention |
Primary outcome
Change in baseline heart failure self-care score at one month
Time frame: Change from baseline heart failure self-care at 1 month
Heart failure self-care is measured by the valid and reliable instrument the Self-Care of Heart Failure Index. Change in scores from baseline at one month will be assessed.
Change in baseline heart failure self-care score at 3 months
Time frame: Change from baseline heart failure self-care at 3 months
Heart failure self-care is measured by the valid and reliable instrument the Self-Care of Heart Failure Index. Change in scores from baseline to 3 months will be assessed.
2 secondary outcomes
Change in baseline Heart failure knowledge score at 1 month
Time frame: Change in baseline Heart failure knowledge score at 1 month
Change in baseline Heart failure knowledge score at 3 month
Time frame: Change in baseline Heart failure knowledge score at 3 month
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 15 Apr 2015.
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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.
Victoria Vaughan Dickson, PhD, RN, FAHA principal investigator
NYU College of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing group-based skill building self-care program in people with Heart Failure, run by NYU Langone Health at 2 sites 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 3 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 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in baseline heart failure self-care score at one month (time frame: Change from baseline heart failure self-care at 1 month). The study lists 2 primary outcomes in all. 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 15 Apr 2015.