Heart FailureNCT03288194
Improving Quality of Life in Heart Failure
A study testing Problem-Solving Treatment and Time Management in people with Heart Failure and Quality of Life, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This research study has been designed to test the efficacy of telephone-delivered Problem-Solving Treatment (PST) for improving the quality of life (QoL) in outpatients with stable heart failure (HF). Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Heart Failure, Quality of Life
- What is being tested?
- Problem-Solving Treatment and Time Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 24 Apr 2017
- Phase
- Interventional
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient
- Age > 21
- Exhibits symptoms of hear failure (NYHA Class II or III)
- Left ventricular ejection fraction (LVEF) >= 40%
- Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score < 60
Who cannot join
- Cannot speak English
- Lack telephone access
- Unwilling to be randomized, or
- Unavailable for the study period
- Awaiting a heart transplant (United Network for Organ Sharing Status 1A or 1B), or
- Planned (within 6 months) cardiac surgery
Show all 20Show fewer
- Cognitive impairment indicative of dementia
- Recent (3 months)
- acute myocardial infarction,
- cardiac decompensation, or
- HF-related hospitalization.
- Use intravenous inotropic medication
- Use an assistive circulatory device
- Significantly reduced life expectancy due to co-morbidity (e.g., malignancy)
- Currently receiving mental health counseling;
- A history of:
- bipolar disorder,
- psychosis, or
- substance abuse/dependency
- Severe depressive symptoms or suicidality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Quality of Life in Outpatients With Heart Failure: A Two-arm Randomized Controlled Trial
This research study has been designed to test the efficacy of telephone-delivered Problem-Solving Treatment (PST) for improving the quality of life (QoL) in outpatients with stable heart failure (HF).
Read the detailed description
Heart failure (HF) is the end stage of all cardiovascular diseases, and it imposes a huge burden in the United States in terms of morbidity, mortality, and economic cost. Although disease management programs have been developed to curb these costs and address the complexities of HF management, evaluations of these programs have yielded equivocal results.
With this study the Investigators plan to: (1) to determine the feasibility of telephone delivered PST for outpatients with HF and reduced QoL by obtaining estimates of yield, retention, patient acceptance, and patient satisfaction; (2) to determine whether telephone-delivered PST is associated with greater improvements in QoL than telephone-delivered Time Management over 8 weeks; and (3) to determine whether telephone-delivered PST is associated with greater reductions in depressive symptoms and/or greater improvements in self-efficacy or objectively assessed daily physical activity than telephone-delivered Time Management over 8 weeks.
- Conditions
- Heart Failure, Quality of Life
- Being tested
- Problem-Solving Treatment, Time Management
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-Solving TreatmentBehavioural
Time ManagementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Problem-Solving Treatment | Experimental | Problem-Solving Treatment is a structured, yet flexible, form of cognitive-behavioral psychotherapy intended to increase problem-solving skills. Receives: Behavioral: Problem-Solving Treatment |
| Time Management | Active comparator | Time Management is a structured, yet flexible, intervention intended to increase creativity. Receives: Behavioral: Time Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Kansas City Cardiomyopathy Questionnaire
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
Measured: 1 month, 2 months, 3 months, 4 months, 5 months
Secondary outcomes (1)
Change in Beck Depression Inventory
The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression.
Measured: 1 month, 2 months, 3 months, 4 months, 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study startOct 2015
- Primary completion24 Apr 2017
- Study completion24 Apr 2017
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 University of Colorado, DenverThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jonathan A Shaffer, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288194
- Sponsor's protocol ID
- 15-1619
- Status last verified
- May 2022
- First submitted
- 15 Sep 2017
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Life in Outpatients With Heart Failure: A Two-arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03288194
- Acronym / sponsor ID
- 15-1619
- Conditions
- Heart Failure, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2015 (actual)
- Primary completion
- 24 Apr 2017 (actual)
- Study completion
- 24 Apr 2017 (actual)
- First posted
- 19 Sep 2017 (actual)
- 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 research study has been designed to test the efficacy of telephone-delivered Problem-Solving Treatment (PST) for improving the quality of life (QoL) in outpatients with stable heart failure (HF).
Detailed description
Heart failure (HF) is the end stage of all cardiovascular diseases, and it imposes a huge burden in the United States in terms of morbidity, mortality, and economic cost. Although disease management programs have been developed to curb these costs and address the complexities of HF management, evaluations of these programs have yielded equivocal results.
With this study the Investigators plan to: (1) to determine the feasibility of telephone delivered PST for outpatients with HF and reduced QoL by obtaining estimates of yield, retention, patient acceptance, and patient satisfaction; (2) to determine whether telephone-delivered PST is associated with greater improvements in QoL than telephone-delivered Time Management over 8 weeks; and (3) to determine whether telephone-delivered PST is associated with greater reductions in depressive symptoms and/or greater improvements in self-efficacy or objectively assessed daily physical activity than telephone-delivered Time Management over 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem-Solving Treatment | Experimental | Behavioral: Problem-Solving TreatmentProblem-Solving Treatment is a structured, yet flexible, form of cognitive-behavioral psychotherapy intended to increase problem-solving skills. |
| Time Management | Active comparator | Behavioral: Time ManagementTime Management is a structured, yet flexible, intervention intended to increase creativity. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatient
- Age > 21
- Exhibits symptoms of hear failure (NYHA Class II or III)
- Left ventricular ejection fraction (LVEF) >= 40%
- Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score < 60
Key exclusion criteria (20 listed)
- Cannot speak English
- Lack telephone access
- Unwilling to be randomized, or
- Unavailable for the study period
- Awaiting a heart transplant (United Network for Organ Sharing Status 1A or 1B), or
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 |
|---|---|---|
| Problem-Solving Treatment | Behavioural | Problem-Solving Treatment |
| Time Management | Behavioural | Time Management |
Primary outcome
Change in Kansas City Cardiomyopathy Questionnaire
Time frame: 1 month, 2 months, 3 months, 4 months, 5 months
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
1 secondary outcome
Change in Beck Depression Inventory
Time frame: 1 month, 2 months, 3 months, 4 months, 5 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 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jonathan A Shaffer, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem-Solving Treatment and Time Management in people with Heart Failure and Quality of Life, run by University of Colorado, Denver 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 20 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 May 2022. 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?
Change in Kansas City Cardiomyopathy Questionnaire (time frame: 1 month, 2 months, 3 months, 4 months, 5 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 May 2022.