Heart FailureNCT03971149
EMPOWER Study, a Personalized Home Care Intervention for Older Heart Failure Patients
A study testing EMPOWER in people with Heart Failure, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to see how investigators may best improve treatment adherence and disease management for heart failure after hospital discharge. This is because the period after hospital discharge is critical to long-term recovery, overall quality of life, and prevention of future hospitalizations. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- EMPOWER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of moderate/severe heart failure at hospital admission, defined by ICD codes (ICD-9 428 or ICD-10 150), New York Heart Association class III/IV, and left ventricular ejection fraction less than or equal to 40% (i.e., echocardiography)
- discharge from heart failure-led hospitalization to home health care in approximately the previous week
- intact or mildly impaired cognitive function (Montreal Cognitive Assessment eligibility scores greater than or equal to 18)
- primary residence in four counties within 30 minutes distance to the University of Rochester
Who cannot join
- end-of-life prognosis in the following 6 months that make it difficult to examine the changes in heart failure outcomes
- currently receiving hospice care
- conditions that impact the receipt of the intervention such as active suicidal ideation that is identified at baseline using the Geriatric Depression Scale and the Geriatric Suicide Ideation Scale
- being non-English speaking
- having serious visual and or hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Feasibility of EMPOWER - A Personalized Adherence Enhancement Intervention for Older Post-discharge Heart Failure Patients
The purpose of this study is to see how investigators may best improve treatment adherence and disease management for heart failure after hospital discharge. This is because the period after hospital discharge is critical to long-term recovery, overall quality of life, and prevention of future hospitalizations. In this study, a trained nurse interventionist will work with the participants to develop a personalized adherence enhancement strategy for heart failure diagnosis. The personalized adherence enhancement strategy is called EMPOWER.
- Conditions
- Heart Failure
- Being tested
- EMPOWER
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPOWERBehavioural
EMPOWER includes 4 weekly home visit and 4 follow up booster phone calls every other week for the following 8 weeks. The trained nurse interventionist will address identified adherence barriers related to knowledge deficits about heart failure and its treatment including psycho-social barriers and logistic barriers with their primary care physician if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Behavorial intervention | Experimental | Not described Receives: Behavioral: EMPOWER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in medication adherence
Adherence will be calculated either by manual pill counting or by the Medication Event Monitoring System, a microelectronic monitoring device on the cap of medication containers.
Measured: week 1 to week 4
Mean change in medication adherence
Adherence will be calculated either by manual pill counting or by the Medication Event Monitoring System, a microelectronic monitoring device on the cap of medication containers.
Measured: week 1 to 3 months
mean change in adherence to low-sodium diet
Adherence to low sodium diet will be assessed by the Dietary Sodium Restriction Questionnaire (DSRQ). The DSRQ is composed of 3 subscales: 1) attitude toward the behavior, 2) subjective norm, and 3) perceived behavioral control.
Attitude. There are 6 items in the Attitude subscale. The scores on this subscale ranged from 6 to 30, where a higher score indicates correct attitudes (better knowledge) about following a low-sodium diet.
Subjective norm. There are 3 items in the Subjective Norm subscale. The scores on this subscale ranged from 3 to 15, where a higher score indicates heavier influence of subjective norm of social contacts on one's adherence to low-sodium diet.
Perceived behavioral control. There are 7 items in the Perceived Behavioral Control subscale. The scores on this subscale ranged from 7 to 35, a higher score indicates a higher likelihood for each item to be a barrier in adherence to low-sodium diet.
Measured: week 1 to week 4
mean change in adherence to low-sodium diet
Adherence to low sodium diet will be assessed by the Dietary Sodium Restriction Questionnaire (DSRQ). The DSRQ is composed of 3 subscales: 1) attitude toward the behavior, 2) subjective norm, and 3) perceived behavioral control.
Attitude. There are 6 items in the Attitude subscale. The scores on this subscale ranged from 6 to 30, where a higher score indicates correct attitudes (better knowledge) about following a low-sodium diet.
Subjective norm. There are 3 items in the Subjective Norm subscale. The scores on this subscale ranged from 3 to 15, where a higher score indicates heavier influence of subjective norm of social contacts on one's adherence to low-sodium diet.
Perceived behavioral control. There are 7 items in the Perceived Behavioral Control subscale. The scores on this subscale ranged from 7 to 35, a higher score indicates a higher likelihood for each item to be a barrier in adherence to low-sodium diet.
Measured: week 1 to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: We came across unexpected difficulty with recruitment.
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 RochesterThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinjiao Wang, University of Rochester
- Investigators
- Jinjiao Wang, PhD, RN, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971149
- Sponsor's protocol ID
- RSRB00003400
- Status last verified
- Apr 2021
- First submitted
- 29 May 2019
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Feasibility of EMPOWER - A Personalized Adherence Enhancement Intervention for Older Post-discharge Heart Failure Patients
- ClinicalTrials.gov ID
- NCT03971149
- Acronym / sponsor ID
- RSRB00003400
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We came across unexpected difficulty with recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Jun 2019 (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.
The purpose of this study is to see how investigators may best improve treatment adherence and disease management for heart failure after hospital discharge. This is because the period after hospital discharge is critical to long-term recovery, overall quality of life, and prevention of future hospitalizations. In this study, a trained nurse interventionist will work with the participants to develop a personalized adherence enhancement strategy for heart failure diagnosis. The personalized adherence enhancement strategy is called EMPOWER.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavorial intervention | Experimental | Behavioral: EMPOWER |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of moderate/severe heart failure at hospital admission, defined by ICD codes (ICD-9 428 or ICD-10 150), New York Heart Association class III/IV, and left ventricular ejection fraction less than or equal to 40% (i.e., echocardiography)
- discharge from heart failure-led hospitalization to home health care in approximately the previous week
- intact or mildly impaired cognitive function (Montreal Cognitive Assessment eligibility scores greater than or equal to 18)
- primary residence in four counties within 30 minutes distance to the University of Rochester
Key exclusion criteria (5 listed)
- end-of-life prognosis in the following 6 months that make it difficult to examine the changes in heart failure outcomes
- currently receiving hospice care
- conditions that impact the receipt of the intervention such as active suicidal ideation that is identified at baseline using the Geriatric Depression Scale and the Geriatric Suicide Ideation Scale
- being non-English speaking
- having serious visual and or hearing impairment
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 |
|---|---|---|
| EMPOWEREMPOWER includes 4 weekly home visit and 4 follow up booster phone calls every other week for the following 8 weeks. The trained nurse interventionist will address identified adherence barriers related to knowledge deficits about heart failure and its treatment including psycho-social barriers and logistic barriers with their primary care physician if necessary. | Behavioural | Behavorial intervention |
Primary outcome
Mean change in medication adherence
Time frame: week 1 to week 4
Adherence will be calculated either by manual pill counting or by the Medication Event Monitoring System, a microelectronic monitoring device on the cap of medication containers.
Mean change in medication adherence
Time frame: week 1 to 3 months
Adherence will be calculated either by manual pill counting or by the Medication Event Monitoring System, a microelectronic monitoring device on the cap of medication containers.
mean change in adherence to low-sodium diet
Time frame: week 1 to week 4
Adherence to low sodium diet will be assessed by the Dietary Sodium Restriction Questionnaire (DSRQ). The DSRQ is composed of 3 subscales: 1) attitude toward the behavior, 2) subjective norm, and 3) perceived behavioral control. Attitude. There are 6 items in the Attitude subscale. The scores on this subscale ranged from 6 to 30, where a higher score indicates correct attitudes (better knowledge) about following a low-sodium diet. Subjective norm. There are 3 items in the Subjective Norm subscale. The scores on this subscale ranged from 3 to 15, where a higher score indicates heavier influence of subjective norm of social contacts on one's adherence to low-sodium diet. Perceived behavioral control. There are 7 items in the Perceived Behavioral Control subscale. The scores on this subscale ranged from 7 to 35, a higher score indicates a higher likelihood for each item to be a barrier in adherence to low-sodium diet.
mean change in adherence to low-sodium diet
Time frame: week 1 to 3 months
Adherence to low sodium diet will be assessed by the Dietary Sodium Restriction Questionnaire (DSRQ). The DSRQ is composed of 3 subscales: 1) attitude toward the behavior, 2) subjective norm, and 3) perceived behavioral control. Attitude. There are 6 items in the Attitude subscale. The scores on this subscale ranged from 6 to 30, where a higher score indicates correct attitudes (better knowledge) about following a low-sodium diet. Subjective norm. There are 3 items in the Subjective Norm subscale. The scores on this subscale ranged from 3 to 15, where a higher score indicates heavier influence of subjective norm of social contacts on one's adherence to low-sodium diet. Perceived behavioral control. There are 7 items in the Perceived Behavioral Control subscale. The scores on this subscale ranged from 7 to 35, a higher score indicates a higher likelihood for each item to be a barrier in adherence to low-sodium diet.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Jinjiao Wang, PhD, RN principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMPOWER in people with Heart Failure, run by University of Rochester 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 20 Apr 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Mean change in medication adherence (time frame: week 1 to week 4). The study lists 4 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 20 Apr 2021.