Heart FailureEACPAHFANCT04424680
Efficacy of an Advanced Care Planning Program in Advanced Heart FAilure
A study testing Advanced Care Planning program of health decisions in people with Heart Failure, run by Hospital Universitario Fundación Alcorcón at 1 site in Spain.
Trial summary
An "Advanced Planning Program of Health Decisions" (APPHD) is a process of reflection and relationship between the patient, their relatives and health professionals. It is based on respect for patient's autonomy, to engage patients in making decisions about their disease so that the process is shared between the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Advanced Care Planning program of health decisions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 1 Jan 2023
- 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
- Patients with HF defined by Framingham diagnostic criteria.
- Stage C or D of the ACCF / AHA classification.
- Full capacity to decide.
- Signing of informed consent.
Who cannot join
- Cognitive impairment, measured by Mini-Mental Status Examination (< 27).
- Presence of another disease other than HF that may severely affect the quality of life: stroke with significant residual deficit, end-stage renal failure, Child C cirrhosis, extreme obesity, haemoglobin <8 g / dl, advanced peripheral artery disease (stage III-IV), severe thyroid or adrenal disease, neoplastic with estimated survival of less than 2 years.
- Patients who do not sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Maria Velasco, Head of investigation unit, 916219597, unidadinvestigacion@fhalcorcon.es
Benjamin Herreros, Principal investigator, 630906473, bherreros@fhalcorcon.es
About this study
Official title: Evaluating the Efficacy of an Advanced Care Planning Program for Health Decisions in Patients With Advanced Heart Failure
An "Advanced Planning Program of Health Decisions" (APPHD) is a process of reflection and relationship between the patient, their relatives and health professionals. It is based on respect for patient's autonomy, to engage patients in making decisions about their disease so that the process is shared between the medical team, the patient and their relatives. Until now, it has not been measured whether the APPHD is effective and, therefore, really fulfills its purpose
Read the detailed description
BACKGROUND: An Advanced Care Planning (ACP) program of health decisions is the result of a process of reflection and relationship-building between the patient, their relatives and health professionals. It is based on respect for patients' autonomy, involving them in making decisions about their disease in a way that is shared between the medical team, the patient and their relatives. Up until now, the efficacy of an ACP has not been measured in the existing literature, and therefore it is unknown if these programs reach their goal. OBJETIVES: The main objective of our study is to evaluate the efficacy of an ACP program for decision-making in patients with advanced heart failure (HF) in comparison to usual follow up and care. This objective will be evaluated by the Patient Activation Measure test, which measures the participation and self-management of the patient in decision-making. Secondary objectives: to evaluate the effect of the program on quality of life, to know if the patients wishes expressed through the ACP program are fulfilled, to measure the impact of the program on patients' caregivers, to determine the satisfaction of patients included in the program and to evaluate the effect on quality of death. METHODS: randomized multicentre clinical trial at four hospitals in Madrid. Once they are included in the study, patients' allocation to groups (control vs intervention) will be made by alternative sampling. ACP will be applied to the intervention group, whereas in the Control Group usual follow-up will be carried out in HF units. All patients will fulfil questionnaires and tests related to the objectives of the study again after a 12-month follow-up period in order to gauge the effect of ACP in patients with advanced HF.
- Conditions
- Heart Failure
- Being tested
- Advanced Care Planning program of health decisions
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Care Planning program of health decisionsBehavioural
Application of an Advanced Care Planning program program for decision-making in patients with advanced Heart Failure, in comparison to usual follow up and care.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients will be followed in heart failure outpatients units according to the usual established protocol. In the first visit, patients from both control and intervention groups will complete the questionnaires with the help of researchers. After one year of follow-up, the questionnaires will be submitted again to all patients and three new questionnaires will be proposed. Treatment for heart failure will be the same in both groups. |
| Intervention | Experimental | Patients will participate in the Advanced Care Planning Program. In the first visit, patients from both control and intervention groups will complete the questionnaires with the help of researchers. After one year of follow-up, the questionnaires will be submitted again to all patients and three new questionnaires will be proposed.
Treatment for heart failure will be the same in both groups. Receives: Behavioral: Advanced Care Planning program of health decisions |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of an Advanced Care Planning program for decision-making in patients with advanced Heart Failure in comparison to usual follow up and care: questionnaire
This objective will be evaluated by the PAM (Patient Activation Measure) test, which measures the participation and self-management of the patient in decision making. PAM measures the activation (participation and self-management) of the patient in decision-making. It evaluates the knowledge, skills and confidence of patients' self-management classifying patients in levels of self-management activation. Level 1: They do not feel responsible for their own health and care. (Score 47.0 or lower); Level 2: They may lack basic understanding about their condition, treatment options, and / or self-care. (47.1 to 55.1); Level 3: They know the basic facts of their illness and treatments. (55.2 to 67); Level 4: They have made most of the decisions, but they may have difficulties in maintaining behaviours over time or in stressful situations (67.1 or higher).
Measured: 24 months
Secondary outcomes (5)
To evaluate the effect of the ACP program on quality of life: questionnaire
This objective will be evaluated by the LWHFQ Questionnaire (Minnesota Living with Heart Failure Questionnaire), which measures the quality of life in patients with HF. Scoring range: 0 to 105 points: The higher the score obtained, the poorer the quality of life of patients. Questions refer to signs and symptoms of the disease, social relationships, physical, sexual activity, work and emotions. It is self-administered, with Likert response options, ranging from 0 (quality of life not affected) to 5 (maximum impact on quality of life). The global score is obtained by adding the 21 items scores (range: 0-105); the highest value corresponds to the worst quality of life. It assesses the impact of chronic heart failure in two dimensions: the physical dimension based on eight items (range: 0-40) and the emotional dimension consisting of five items (range: 0-25).
Measured: 24 months
To know if the patients wishes expressed through the ACP program are fulfilled
This objective will be evaluated by a Checklist to test the fulfilment of planned patient's wishes.
Measured: 24 months
To determine the level of satisfaction with the ACP program of patients included in the program.
This objective will be evaluated by a Satisfaction test Created "ad hoc". It aims to assess the level of satisfaction with the program. Its outcome will help improve the future implementation of the program.
Satisfaction test. Answer YES or NO
- Did you understand what the Program was about?
- Do you feel you received enough information, orally or in writing, for your understanding?
- Did you feel that you could easily access the doctors responsible for the program to answer your questions?
- Do you think that the doctors responsible for the program have the necessary skills and knowledge?
- Did you understand without difficulty what these professionals communicated in each interview?
- Has the program met your expectations and needs?
- Did you find it easy to get to the office and / or day hospital?
Measured: 24 months
To evaluate the effect on quality of death: questionnaire
This objective will be evaluated by the Dying and Death quality questionnaire (QODD). This questionnaire measures the quality of the dying process.
Quality of Dying and Death - 17-Item Version: Each item includes a filter question reporting what actually occurred during the final period of the decedent's life, followed by a rating of what occurred. The first 10 filter questions ask the frequency of occurrence and use the following response options: 0: none of the time; 1: a little bit of the time ; 2: some of the time; 3: a good bit of the time; 4: most of the time; 5: all of the time. The last 7 filter questions ask whether the event occurred and are answered with a yes/no response. After each filter question, the respondent rates the decedent's experience, using the following scale: 0 = terrible experience…10 = almost perfect experience.
Measured: 24 months
To measure the impact of the ACP program on patients' caregivers
This objective will be evaluated by the Zarit questionnaire about caregiver's burden.
Zarit questionnaire about caregiver's burden. This interview measures caregivers' degree of subjective overload in relation to chronic patients. It consists of 22 items that collect caregivers' feelings. Each feeling scores on a frequency gradient that ranges from 1 (never) to 5 (almost always). Interpretation:
- or <45 points: no overload
- 47 to 55 points: slight overload
- or> 55 points: intense overload
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jan 2020
- Primary completion31 Mar 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Once patients have been included in the study, the assignment process will be carried out by random sampling to the study groups. In the First Group (control group), patients will be followed in HF outpatients units according to the usual established protocol. In the Second Group (intervention group), patients will participate in the ACP program. Treatment for HF will be the same in both groups. The research team has developed the ACP program based on the published bibliography on ACP and advanced HF. The four hospitals mentioned will start recruiting at the beginning of the study. The principal investigator will be responsible for interrupting recruitment once the sample size has been reached.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Fundación Alcorcón
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamín Herreros Ruiz Valdepeñas, Hospital Universitario Fundación Alcorcón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424680
- Sponsor's protocol ID
- HUFAlcoron
- Acronym
- EACPAHFA
- Status last verified
- Jun 2020
- First submitted
- 29 May 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The databases to be managed will be anonymous
Publications
Perez M, Herreros B, Martin MD, Molina J, Kanouzi J, Velasco M. Do Spanish Hospital Professionals Educate Their Patients About Advance Directives? : A Descriptive Study in a University Hospital in Madrid, Spain. J Bioeth Inq. 2016 Jun;13(2):295-303. doi: 10.1007/s11673-016-9703-7. Epub 2016 Jan 21.
PubMed 26797513Perez M, Herreros B, Martin MD, Molina J, Guijarro C, Velasco M. [Changes in knowledge and carrying out the advance directives of patients admitted to internal medicine]. Rev Calid Asist. 2013 Sep-Oct;28(5):307-12. doi: 10.1016/j.cali.2013.03.008. Epub 2013 Sep 7. Spanish.
PubMed 24021533Molina J, Perez M, Herreros B, Martin MD, Velasco M. [Knowledge and attitude regarding previous instructions for the patients of a public hospital of Madrid]. Rev Clin Esp. 2011 Oct;211(9):450-4. doi: 10.1016/j.rce.2011.06.007. Epub 2011 Aug 2. Spanish.
PubMed 21813119Miles SH, Koepp R, Weber EP. Advance end-of-life treatment planning. A research review. Arch Intern Med. 1996 May 27;156(10):1062-8.
PubMed 8638992Gomez-Batiste X, Martinez-Munoz M, Blay C, Amblas J, Vila L, Costa X, Espaulella J, Villanueva A, Oller R, Martori JC, Constante C. Utility of the NECPAL CCOMS-ICO(c) tool and the Surprise Question as screening tools for early palliative care and to predict mortality in patients with advanced chronic conditions: A cohort study. Palliat Med. 2017 Sep;31(8):754-763. doi: 10.1177/0269216316676647. Epub 2016 Nov 4.
PubMed 27815556Sanchez B, Guijarro C, Velasco M, Vicente MJ, Galan M, Herreros B. Evaluating the efficacy of an Advanced Care Planning Program for Health Decisions in patients with advanced heart failure: protocol for a Randomized Clinical Trial. BMC Cardiovasc Disord. 2020 Oct 21;20(1):456. doi: 10.1186/s12872-020-01738-0.
PubMed 33087061
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of an Advanced Care Planning Program for Health Decisions in Patients With Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT04424680
- Acronym / sponsor ID
- EACPAHFA / HUFAlcoron
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hospital Universitario Fundación AlcorcónUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 11 Jun 2020 (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.
An "Advanced Planning Program of Health Decisions" (APPHD) is a process of reflection and relationship between the patient, their relatives and health professionals. It is based on respect for patient's autonomy, to engage patients in making decisions about their disease so that the process is shared between the medical team, the patient and their relatives. Until now, it has not been measured whether the APPHD is effective and, therefore, really fulfills its purpose
Detailed description
BACKGROUND: An Advanced Care Planning (ACP) program of health decisions is the result of a process of reflection and relationship-building between the patient, their relatives and health professionals. It is based on respect for patients' autonomy, involving them in making decisions about their disease in a way that is shared between the medical team, the patient and their relatives. Up until now, the efficacy of an ACP has not been measured in the existing literature, and therefore it is unknown if these programs reach their goal. OBJETIVES: The main objective of our study is to evaluate the efficacy of an ACP program for decision-making in patients with advanced heart failure (HF) in comparison to usual follow up and care. This objective will be evaluated by the Patient Activation Measure test, which measures the participation and self-management of the patient in decision-making. Secondary objectives: to evaluate the effect of the program on quality of life, to know if the patients wishes expressed through the ACP program are fulfilled, to measure the impact of the program on patients' caregivers, to determine the satisfaction of patients included in the program and to evaluate the effect on quality of death. METHODS: randomized multicentre clinical trial at four hospitals in Madrid. Once they are included in the study, patients' allocation to groups (control vs intervention) will be made by alternative sampling. ACP will be applied to the intervention group, whereas in the Control Group usual follow-up will be carried out in HF units. All patients will fulfil questionnaires and tests related to the objectives of the study again after a 12-month follow-up period in order to gauge the effect of ACP in patients with advanced HF.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Once patients have been included in the study, the assignment process will be carried out by random sampling to the study groups. In the First Group (control group), patients will be followed in HF outpatients units according to the usual established protocol. In the Second Group (intervention group), patients will participate in the ACP program. Treatment for HF will be the same in both groups. The research team has developed the ACP program based on the published bibliography on ACP and advanced HF. The four hospitals mentioned will start recruiting at the beginning of the study. The principal investigator will be responsible for interrupting recruitment once the sample size has been reached.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients will be followed in heart failure outpatients units according to the usual established protocol. In the first visit, patients from both control and intervention groups will complete the questionnaires with the help of researchers. After one year of follow-up, the questionnaires will be submitted again to all patients and three new questionnaires will be proposed. Treatment for heart failure will be the same in both groups. |
| Intervention | Experimental | Behavioral: Advanced Care Planning program of health decisionsPatients will participate in the Advanced Care Planning Program. In the first visit, patients from both control and intervention groups will complete the questionnaires with the help of researchers. After one year of follow-up, the questionnaires will be submitted again to all patients and three new questionnaires will be proposed. Treatment for heart failure will be the same in both groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with HF defined by Framingham diagnostic criteria.
- Stage C or D of the ACCF / AHA classification.
- Full capacity to decide.
- Signing of informed consent.
Key exclusion criteria (3 listed)
- Cognitive impairment, measured by Mini-Mental Status Examination (< 27).
- Presence of another disease other than HF that may severely affect the quality of life: stroke with significant residual deficit, end-stage renal failure, Child C cirrhosis, extreme obesity, haemoglobin <8 g / dl, advanced peripheral artery disease (stage III-IV), severe thyroid or adrenal disease, neoplastic with estimated survival of less than 2 years.
- Patients who do not sign the informed consent.
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 |
|---|---|---|
| Advanced Care Planning program of health decisionsApplication of an Advanced Care Planning program program for decision-making in patients with advanced Heart Failure, in comparison to usual follow up and care. | Behavioural | Intervention |
Primary outcome
To evaluate the efficacy of an Advanced Care Planning program for decision-making in patients with advanced Heart Failure in comparison to usual follow up and care: questionnaire
Time frame: 24 months
This objective will be evaluated by the PAM (Patient Activation Measure) test, which measures the participation and self-management of the patient in decision making. PAM measures the activation (participation and self-management) of the patient in decision-making. It evaluates the knowledge, skills and confidence of patients' self-management classifying patients in levels of self-management activation. Level 1: They do not feel responsible for their own health and care. (Score 47.0 or lower); Level 2: They may lack basic understanding about their condition, treatment options, and / or self-care. (47.1 to 55.1); Level 3: They know the basic facts of their illness and treatments. (55.2 to 67); Level 4: They have made most of the decisions, but they may have difficulties in maintaining behaviours over time or in stressful situations (67.1 or higher).
5 secondary outcomes
To evaluate the effect of the ACP program on quality of life: questionnaire
Time frame: 24 months
To know if the patients wishes expressed through the ACP program are fulfilled
Time frame: 24 months
To determine the level of satisfaction with the ACP program of patients included in the program.
Time frame: 24 months
To evaluate the effect on quality of death: questionnaire
Time frame: 24 months
To measure the impact of the ACP program on patients' caregivers
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Results publication: PubMed 26797513Perez M, Herreros B, Martin MD, Molina J, Kanouzi J, Velasco M. Do Spanish Hospital Professionals Educate Their Patients About Advance Directives? : A Descriptive Study in a University Hospital in Madrid, Spain. J Bioeth Inq. 2016 Jun;13(2):295-303. doi: 10.1007/s11673-016-9703-7. Epub 2016 Jan 21.
- Results publication: PubMed 24021533Perez M, Herreros B, Martin MD, Molina J, Guijarro C, Velasco M. [Changes in knowledge and carrying out the advance directives of patients admitted to internal medicine]. Rev Calid Asist. 2013 Sep-Oct;28(5):307-12. doi: 10.1016/j.cali.2013.03.008. Epub 2013 Sep 7. Spanish.
- Results publication: PubMed 21813119Molina J, Perez M, Herreros B, Martin MD, Velasco M. [Knowledge and attitude regarding previous instructions for the patients of a public hospital of Madrid]. Rev Clin Esp. 2011 Oct;211(9):450-4. doi: 10.1016/j.rce.2011.06.007. Epub 2011 Aug 2. Spanish.
- Results publication: PubMed 8638992Miles SH, Koepp R, Weber EP. Advance end-of-life treatment planning. A research review. Arch Intern Med. 1996 May 27;156(10):1062-8.
- Results publication: PubMed 27815556Gomez-Batiste X, Martinez-Munoz M, Blay C, Amblas J, Vila L, Costa X, Espaulella J, Villanueva A, Oller R, Martori JC, Constante C. Utility of the NECPAL CCOMS-ICO(c) tool and the Surprise Question as screening tools for early palliative care and to predict mortality in patients with advanced chronic conditions: A cohort study. Palliat Med. 2017 Sep;31(8):754-763. doi: 10.1177/0269216316676647. Epub 2016 Nov 4.
- Derived from this study: PubMed 33087061Sanchez B, Guijarro C, Velasco M, Vicente MJ, Galan M, Herreros B. Evaluating the efficacy of an Advanced Care Planning Program for Health Decisions in patients with advanced heart failure: protocol for a Randomized Clinical Trial. BMC Cardiovasc Disord. 2020 Oct 21;20(1):456. doi: 10.1186/s12872-020-01738-0.
- Individual participant dataSharing planned: Yes. The databases to be managed will be anonymous
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Care Planning program of health decisions in people with Heart Failure, run by Hospital Universitario Fundación Alcorcón at 1 site in Spain.
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 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of an Advanced Care Planning program for decision-making in patients with advanced Heart Failure in comparison to usual follow up and care: questionnaire (time frame: 24 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 NCT04424680, which also lists 6 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 11 Jun 2020.