Heart FailurePATCHNCT01964053
Self-management Adherence in Heart Failure Patients
A study testing PATCH intervention in people with Heart Failure, run by University of Nebraska at 2 sites in United States.
Trial summary
Non-adherence to self-management behaviors is prevalent and accounts for hospital readmissions in heart failure (HF) patients 65 years of age and older. The mechanism to activate and engage HF patients in managing their own care is uncertain. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- PATCH intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2013to 1 Mar 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have HF as one of their discharge diagnoses;
- have New York Heart Association (NYHA) class II to IV symptoms or have NYHA class I symptoms
- have had at least one other HF-related hospitalization or emergency department visit in the previous year;
- are discharged to home;
- pass a mini-cog screen
- understand English;
- have access to a phone.
Who cannot join
- Have scheduled procedures and/or surgeries during hospitalization;
- Have depressive symptoms (receive a score of 3 or above on the Patient Health Questionnaire-2 (PHQ-2) have documented medical diagnosis or diagnostic evidence of liver cirrhosis;
- Have renal failure (serum creatinine greater than 2.0mg/dl)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beatrice Community Hospital & Health Center
Beatrice, Nebraska, 68310
Jefferson Community Health Center
Fairbury, Nebraska, 68352
About this study
Official title: Promoting Self-management Through Adherence Among Heart Failure Patients
Non-adherence to self-management behaviors is prevalent and accounts for hospital readmissions in heart failure (HF) patients 65 years of age and older. The mechanism to activate and engage HF patients in managing their own care is uncertain. Yet post-acute care service that is vital to improve HF patients' self-management adherence and HF outcomes is suboptimal in rural hospitals (primarily critical access hospitals). The investigators central hypothesis is that patients with higher activation level will have significantly better self-management adherence. This study will test whether Patient AcTivated Care at Home (PATCH) will improve self-management adherence and health outcome (reduced hospital readmissions), as well as the feasibility to translate the research findings to a home based post-acute care service in rural communities.
Read the detailed description
Heart failure (HF) is among the most prevalent chronic conditions and leading cause of hospital readmission in adults 65 years of age and older. HF patients discharged from rural critical access hospitals (CAHs) had higher 30-day readmission rates compared to patients discharged from urban hospitals. Adhering to recommended self-management behaviors improves HF patients' health outcomes and reduces readmissions; however, the prevalence of adherence is low in HF patients. In rural communities, low adherence can be attributed to the fact that rural HF patients received less information about managing their chronic condition based on the investigators preliminary study. Previous studies reported inconsistent findings regarding the effectiveness of interventions designed to improve self-management adherence. The feasibility of these interventions in rural settings is unknown. Therefore, innovative programs are needed to identify the intervention to enhance self-management adherence in HF patients living in rural communities. The purpose of this prospective, two-group, repeated measures, randomized control trial is to test the efficacy and feasibility of a 12-week activation-enhancing intervention (Patient AcTivated Care at Home [PATCH]) on self-management adherence and health outcome (readmission rates) in HF patients discharged from rural hospitals (critical access hospitals). A sample size of 96 subjects with heart failure will be recruited over 14 month period. Both intervention and control groups will receive usual care. The intervention group will additionally receive 2-phase PATCH intervention: the in-hospital discharge education session (Phase I) and 12-week post-discharge education sessions delivered by telephone (Phase II). The tailored strategies are developed to activate patients engaging in self-management behaviors based on their baseline activation level. The investigators central hypothesis, based upon their preliminary data, is that patients with higher activation level will have significantly better self-management adherence. The investigators will test their hypothesis with the following Specific Aims: To evaluate the effects of the patient activation intervention on self-management adherence (Aim 1) and hospital readmissions (Aim 2) over time. To evaluate the mechanism of the patient activation intervention (Aim 3). To evaluate the feasibility of the PATCH intervention (Aim 4). The PATCH intervention is innovative because: 1) it translates patient activation theory into intervention strategies to improve self-management in a vulnerable population (rural heart failure patients living in rural community), 2) it tests the mechanism of patient activation on self-management adherence; 3) it uses the rural nursing theory to guide developing a sustainable intervention program in rural communities; and 4) it evaluates a biomarker collected by a single urine test as the indicator of self-management adherence in HF patients. This study will impact the management of heart failure by adding knowledge about the mechanism to improve self-management adherence in heart failure patient living in rural communities. Long term adherence to the recommended self-management behaviors is the foundation to realize health benefit and reduce burden on patients, their family and the healthcare system.
- Conditions
- Heart Failure
- Being tested
- PATCH intervention, Usual care
- Keywords
- Self-management adherence, post acute care, critical access hospitals, patient activation, hospital readmission
- Medical subject headings
- Heart Failure, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATCH interventionBehavioural
The intervention group will receive usual care and the PATCH intervention. The intervention is comprised of two phases in which the in-hospital discharge education session is followed by 12 weeks of post-discharge education sessions delivered by telephone. The focus of this study is to test the mechanism of the proposed patient activation intervention on HF self-management adherence and associated health outcomes.
Usual careBehavioural
Usual care refers to the standardized discharge written information and scheduled doctor appointments. Standardized discharge instruction, as recommended by CMS and the Joint Commission, includes: activity level, diet, discharge medications, follow-up doctor appointment, weight monitoring, and what to do if symptoms worsen.113 No further follow-ups are routinely done by the hospital and patients are told to see their primary care provider if problems occur.
| Study group | Role | What they receive |
|---|---|---|
| PATCH Intervention | Experimental | The intervention group will receive usual care and the PATCH intervention. The intervention is comprised of two phases in which the in-hospital discharge education session is followed by 12 weeks of post-discharge education sessions delivered by telephone. The focus of this study is to test the mechanism of the proposed patient activation intervention on HF self-management adherence and associated health outcomes. Receives: Behavioral: PATCH intervention |
| Usual Care | Active comparator | The usual care group will receive standardized discharge written information and scheduled doctor appointments. Standardized discharge instruction, as recommended by CMS and the Joint Commission, includes: activity level, diet, discharge medications, follow-up doctor appointment, weight monitoring, and what to do if symptoms worsen. No further follow-ups are routinely done by the hospital and patients are told to see their primary care provider if problems occur. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in self-management adherence at 3 and 6 months
Primary outcome of self-management adherence refers to the adherence to self-care behaviors
Measured: 3 and 6 months following intervention
Secondary outcomes (1)
Change from Baseline in re-hospitalization rate at 30-day, 3 and 6 months
Evaluate the immediate and extended effects of the patient activation intervention on the re-hospitalization rate in heart failure patients
Measured: 30 day after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study start1 Oct 2013
- Primary completion1 Mar 2016
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lufei Young, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964053
- Sponsor's protocol ID
- 0228-13-EP
- Acronym
- PATCH
- Status last verified
- Aug 2023
- First submitted
- 10 Oct 2013
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Young L, Hertzog M, Barnason S. Effects of a home-based activation intervention on self-management adherence and readmission in rural heart failure patients: the PATCH randomized controlled trial. BMC Cardiovasc Disord. 2016 Sep 8;16(1):176. doi: 10.1186/s12872-016-0339-7.
PubMed 27608624Young L, Barnason S, Do V. Promoting self-management through adherence among heart failure patients discharged from rural hospitals: a study protocol. F1000Res. 2014 Dec 30;3:317. doi: 10.12688/f1000research.5998.2. eCollection 2014.
PubMed 25844160
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Self-management Through Adherence Among Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01964053
- Acronym / sponsor ID
- PATCH / 0228-13-EP
- Conditions
- Heart Failure
- Keywords
- Self-management adherence, post acute care, critical access hospitals, patient activation, hospital readmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 17 Oct 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.
Non-adherence to self-management behaviors is prevalent and accounts for hospital readmissions in heart failure (HF) patients 65 years of age and older. The mechanism to activate and engage HF patients in managing their own care is uncertain. Yet post-acute care service that is vital to improve HF patients' self-management adherence and HF outcomes is suboptimal in rural hospitals (primarily critical access hospitals). The investigators central hypothesis is that patients with higher activation level will have significantly better self-management adherence. This study will test whether Patient AcTivated Care at Home (PATCH) will improve self-management adherence and health outcome (reduced hospital readmissions), as well as the feasibility to translate the research findings to a home based post-acute care service in rural communities.
Detailed description
Heart failure (HF) is among the most prevalent chronic conditions and leading cause of hospital readmission in adults 65 years of age and older. HF patients discharged from rural critical access hospitals (CAHs) had higher 30-day readmission rates compared to patients discharged from urban hospitals. Adhering to recommended self-management behaviors improves HF patients' health outcomes and reduces readmissions; however, the prevalence of adherence is low in HF patients. In rural communities, low adherence can be attributed to the fact that rural HF patients received less information about managing their chronic condition based on the investigators preliminary study. Previous studies reported inconsistent findings regarding the effectiveness of interventions designed to improve self-management adherence. The feasibility of these interventions in rural settings is unknown. Therefore, innovative programs are needed to identify the intervention to enhance self-management adherence in HF patients living in rural communities. The purpose of this prospective, two-group, repeated measures, randomized control trial is to test the efficacy and feasibility of a 12-week activation-enhancing intervention (Patient AcTivated Care at Home [PATCH]) on self-management adherence and health outcome (readmission rates) in HF patients discharged from rural hospitals (critical access hospitals). A sample size of 96 subjects with heart failure will be recruited over 14 month period. Both intervention and control groups will receive usual care. The intervention group will additionally receive 2-phase PATCH intervention: the in-hospital discharge education session (Phase I) and 12-week post-discharge education sessions delivered by telephone (Phase II). The tailored strategies are developed to activate patients engaging in self-management behaviors based on their baseline activation level. The investigators central hypothesis, based upon their preliminary data, is that patients with higher activation level will have significantly better self-management adherence. The investigators will test their hypothesis with the following Specific Aims: To evaluate the effects of the patient activation intervention on self-management adherence (Aim 1) and hospital readmissions (Aim 2) over time. To evaluate the mechanism of the patient activation intervention (Aim 3). To evaluate the feasibility of the PATCH intervention (Aim 4). The PATCH intervention is innovative because: 1) it translates patient activation theory into intervention strategies to improve self-management in a vulnerable population (rural heart failure patients living in rural community), 2) it tests the mechanism of patient activation on self-management adherence; 3) it uses the rural nursing theory to guide developing a sustainable intervention program in rural communities; and 4) it evaluates a biomarker collected by a single urine test as the indicator of self-management adherence in HF patients. This study will impact the management of heart failure by adding knowledge about the mechanism to improve self-management adherence in heart failure patient living in rural communities. Long term adherence to the recommended self-management behaviors is the foundation to realize health benefit and reduce burden on patients, their family and the healthcare system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATCH Intervention | Experimental | Behavioral: PATCH interventionThe intervention group will receive usual care and the PATCH intervention. The intervention is comprised of two phases in which the in-hospital discharge education session is followed by 12 weeks of post-discharge education sessions delivered by telephone. The focus of this study is to test the mechanism of the proposed patient activation intervention on HF self-management adherence and associated health outcomes. |
| Usual Care | Active comparator | Behavioral: Usual careThe usual care group will receive standardized discharge written information and scheduled doctor appointments. Standardized discharge instruction, as recommended by CMS and the Joint Commission, includes: activity level, diet, discharge medications, follow-up doctor appointment, weight monitoring, and what to do if symptoms worsen. No further follow-ups are routinely done by the hospital and patients are told to see their primary care provider if problems occur. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- have HF as one of their discharge diagnoses;
- have New York Heart Association (NYHA) class II to IV symptoms or have NYHA class I symptoms
- have had at least one other HF-related hospitalization or emergency department visit in the previous year;
- are discharged to home;
- pass a mini-cog screen
Key exclusion criteria (3 listed)
- Have scheduled procedures and/or surgeries during hospitalization;
- Have depressive symptoms (receive a score of 3 or above on the Patient Health Questionnaire-2 (PHQ-2) have documented medical diagnosis or diagnostic evidence of liver cirrhosis;
- Have renal failure (serum creatinine greater than 2.0mg/dl)
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 |
|---|---|---|
| PATCH interventionThe intervention group will receive usual care and the PATCH intervention. The intervention is comprised of two phases in which the in-hospital discharge education session is followed by 12 weeks of post-discharge education sessions delivered by telephone. The focus of this study is to test the mechanism of the proposed patient activation intervention on HF self-management adherence and associated health outcomes. | Behavioural | PATCH Intervention |
| Usual careUsual care refers to the standardized discharge written information and scheduled doctor appointments. Standardized discharge instruction, as recommended by CMS and the Joint Commission, includes: activity level, diet, discharge medications, follow-up doctor appointment, weight monitoring, and what to do if symptoms worsen.113 No further follow-ups are routinely done by the hospital and patients are told to see their primary care provider if problems occur. | Behavioural | Usual Care |
Primary outcome
Change from Baseline in self-management adherence at 3 and 6 months
Time frame: 3 and 6 months following intervention
Primary outcome of self-management adherence refers to the adherence to self-care behaviors
1 secondary outcome
Change from Baseline in re-hospitalization rate at 30-day, 3 and 6 months
Time frame: 30 day after intervention
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 Sep 2023.
- Derived from this study: PubMed 27608624Young L, Hertzog M, Barnason S. Effects of a home-based activation intervention on self-management adherence and readmission in rural heart failure patients: the PATCH randomized controlled trial. BMC Cardiovasc Disord. 2016 Sep 8;16(1):176. doi: 10.1186/s12872-016-0339-7.
- Derived from this study: PubMed 25844160Young L, Barnason S, Do V. Promoting self-management through adherence among heart failure patients discharged from rural hospitals: a study protocol. F1000Res. 2014 Dec 30;3:317. doi: 10.12688/f1000research.5998.2. eCollection 2014.
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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.
Lufei Young, PhD principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PATCH intervention in people with Heart Failure, run by University of Nebraska 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 7 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 6 Sep 2023. 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.
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 from Baseline in self-management adherence at 3 and 6 months (time frame: 3 and 6 months following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01964053, which also lists 2 linked publications.
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 Sep 2023.