Heart Failure, CongestiveNCT00439842
Self-Management and Care of Heart Failure With Group Clinics (SMAC-HF)
A study testing Heart Failure Group Clinic Appointments in people with Heart Failure, Congestive, run by Carol Smith, RN, PhD, FAAN at 1 site in United States.
Trial summary
The purpose of this study is to help people with heart failure (HF) to manage their HF and to prevent rehospitalizations. Another purpose is to test the usefulness of clinical appointments and educational videotapes in teaching patients how to manage their HF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- Heart Failure Group Clinic Appointments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Nov 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- speak English/Spanish
- receiving treatment for congestive heart failure
- receiving IV diuretics
- 2 or more HF symptoms
- be able to participate in follow up visits
Who cannot join
- primary right-sided heart failure
- HF transient \& related to acute MI
- HF due to correctable cause
- being scheduled for coronary revascularization or any readmission
- receiving infusion for HF therapy within 2 weeks
- having co-morbidities, life expectancy < 12 months
Show all 11Show fewer
- severe cognitive impairment
- D/C to nursing facilities or rehab unit
- Currently enrolled in an intervention study or HF management program
- being or planning to become pregnant within 12 months
- severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: HF Group Clinic Appointments: Rehospitalization Prevention
The purpose of this study is to help people with heart failure (HF) to manage their HF and to prevent rehospitalizations. Another purpose is to test the usefulness of clinical appointments and educational videotapes in teaching patients how to manage their HF.
It is proposed that the group clinic intervention (HFcareGroup)will reduce rehospitalization, depression, and improve problem solving related to heart failure symptoms.
Read the detailed description
Aim 1 Hypothesis:
- The time to the 1st composite endpoint (HF Rehospitalization/death) will be longer for HFcareGroup than standard care group at 12 months.
- The HFcareGroup will have higher score than standard care on patient outcomes i.e. functional health status, quality of life, satisfaction with health care at 12 months.
- Health Services Use will be lower in HFcareGroup than standard care group at 12 months.
Aim 2 Hypothesis:
- The HFcareGroup will have higher score than standard care on patients' HF self-management i.e., self-care behaviors, participation with health care professionals in HF management and problem-solving, HF knowledge and preparedness for home care at 6 and 12 months.
- A greater proportion of HFcareGroup vs standard care subjects will report clinical or symptoms of HF decompensation (e.g. specific weight gain, shortness of breath, edema, fatigue, tachycardia, and medication side effects) to their health care provider.
- Conditions
- Heart Failure, Congestive
- Being tested
- Heart Failure Group Clinic Appointments
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Failure Group Clinic AppointmentsBehavioural
Also called HFcareGroup
Self Management and Care of Heart Failure with Group Clinics (SMAC-HF)
| Study group | Role | What they receive |
|---|---|---|
| HF group clinic appointments | Experimental | HF group clinic appointments Heart failure multidisciplinary group clinic appointments (Arm 1 - HFcareGroup) includes 6 teaching sessions with patients led by nurse practitioner. Receives: Behavioral: Heart Failure Group Clinic Appointments |
| Standard HF care | No intervention | Standard HF care Standard heart failure education includes cardiologists instructions and hospital discharge information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
rehospitalization or death
Measured: 12 months
Secondary outcomes (3)
HF self-management:problem-solving, self-care behaviors
Measured: 6 and 12 months
heart failure knowledge and preparedness for home care
Measured: 6 and 12 months
functional health status, quality of life, satisfaction with health care, health services use
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionMay 2013
- Study completionNov 2014
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 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Smith, RN, PhD, FAAN
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Carol Smith, RN, PhD, FAAN, University of Kansas Medical Center
- Investigators
- Carol Smith, PhD, RN, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439842
- Sponsor's protocol ID
- 1R01HL085397-05
- Other IDs
- R01HL085397
- Status last verified
- Apr 2015
- First submitted
- 22 Feb 2007
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Piamjariyakul U, Shapiro AL, Wang K, Zulfikar R, Petitte T, Shafique S, Smith CE. Impact of Sleep Apnea, Daytime Sleepiness, Comorbidities, and Depression on Patients' Heart Failure Health Status. Clin Nurs Res. 2021 Nov;30(8):1222-1230. doi: 10.1177/10547738211015545. Epub 2021 May 12.
PubMed 33978519Smith CE, Piamjariyakul U, Wick JA, Spertus JA, Russell C, Dalton KM, Elyachar A, Vacek JL, Reeder KM, Nazir N, Ellerbeck EF. Multidisciplinary group clinic appointments: the Self-Management and Care of Heart Failure (SMAC-HF) trial. Circ Heart Fail. 2014 Nov;7(6):888-94. doi: 10.1161/CIRCHEARTFAILURE.113.001246. Epub 2014 Sep 18.
PubMed 25236883
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HF Group Clinic Appointments: Rehospitalization Prevention
- ClinicalTrials.gov ID
- NCT00439842
- Acronym / sponsor ID
- 1R01HL085397-05
- Conditions
- Heart Failure, Congestive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Carol Smith, RN, PhD, FAANUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2007
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 26 Feb 2007 (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 help people with heart failure (HF) to manage their HF and to prevent rehospitalizations. Another purpose is to test the usefulness of clinical appointments and educational videotapes in teaching patients how to manage their HF.
It is proposed that the group clinic intervention (HFcareGroup)will reduce rehospitalization, depression, and improve problem solving related to heart failure symptoms.
Detailed description
Aim 1 Hypothesis:
- The time to the 1st composite endpoint (HF Rehospitalization/death) will be longer for HFcareGroup than standard care group at 12 months.
- The HFcareGroup will have higher score than standard care on patient outcomes i.e. functional health status, quality of life, satisfaction with health care at 12 months.
- Health Services Use will be lower in HFcareGroup than standard care group at 12 months.
Aim 2 Hypothesis:
- The HFcareGroup will have higher score than standard care on patients' HF self-management i.e., self-care behaviors, participation with health care professionals in HF management and problem-solving, HF knowledge and preparedness for home care at 6 and 12 months.
- A greater proportion of HFcareGroup vs standard care subjects will report clinical or symptoms of HF decompensation (e.g. specific weight gain, shortness of breath, edema, fatigue, tachycardia, and medication side effects) to their health care provider.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HF group clinic appointments | Experimental | Behavioral: Heart Failure Group Clinic AppointmentsHF group clinic appointments Heart failure multidisciplinary group clinic appointments (Arm 1 - HFcareGroup) includes 6 teaching sessions with patients led by nurse practitioner. |
| Standard HF care | No intervention | –Standard HF care Standard heart failure education includes cardiologists instructions and hospital discharge information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- speak English/Spanish
- receiving treatment for congestive heart failure
- receiving IV diuretics
- 2 or more HF symptoms
Key exclusion criteria (11 listed)
- primary right-sided heart failure
- HF transient \& related to acute MI
- HF due to correctable cause
- being scheduled for coronary revascularization or any readmission
- receiving infusion for HF therapy within 2 weeks
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 |
|---|---|---|
| Heart Failure Group Clinic AppointmentsAlso: HFcareGroupSelf Management and Care of Heart Failure with Group Clinics (SMAC-HF) | Behavioural | HF group clinic appointments |
Primary outcome
rehospitalization or death
Time frame: 12 months
3 secondary outcomes
HF self-management:problem-solving, self-care behaviors
Time frame: 6 and 12 months
heart failure knowledge and preparedness for home care
Time frame: 6 and 12 months
functional health status, quality of life, satisfaction with health care, health services use
Time frame: 12 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 17 Apr 2015.
- Derived from this study: PubMed 33978519Piamjariyakul U, Shapiro AL, Wang K, Zulfikar R, Petitte T, Shafique S, Smith CE. Impact of Sleep Apnea, Daytime Sleepiness, Comorbidities, and Depression on Patients' Heart Failure Health Status. Clin Nurs Res. 2021 Nov;30(8):1222-1230. doi: 10.1177/10547738211015545. Epub 2021 May 12.
- Derived from this study: PubMed 25236883Smith CE, Piamjariyakul U, Wick JA, Spertus JA, Russell C, Dalton KM, Elyachar A, Vacek JL, Reeder KM, Nazir N, Ellerbeck EF. Multidisciplinary group clinic appointments: the Self-Management and Care of Heart Failure (SMAC-HF) trial. Circ Heart Fail. 2014 Nov;7(6):888-94. doi: 10.1161/CIRCHEARTFAILURE.113.001246. Epub 2014 Sep 18.
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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.
Carol Smith, PhD, RN principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Failure Group Clinic Appointments in people with Heart Failure, Congestive, run by Carol Smith, RN, PhD, FAAN 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 6 inclusion and 11 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 17 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 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?
rehospitalization or death (time frame: 12 months). 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 NCT00439842, 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 17 Apr 2015.