Background
Methods
Design and study population
Inclusion criteria |
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 |
Exclusion criteria |
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 |
Objectives
Study procedure
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PAM (Patient Activation Measure) Test (Table 2) [16]: test to measure 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. It also values the degree of patients’ implication in making decisions about their lives (in their self-management). This procedure has been previously applied to frail elderly patients in a Dutch study in order to measure patients’ activation in decision making. The test divides the patients in four levels according to their decision-making capacity:Table 2The PAM 13 measurement instrumentPAM assesses a consumer’s knowledge, skills and confidence for self-management. PAM segments people into one of four progressively higher levels of activation. Below are some statements that people sometimes make when they talk about their health. Please indicate how much you agree or disagree with each statement as it applies to you personally by circling your answer. Your answers should be what is true for you and not just what you think others want you to say1When all is said and done, I am the person who is responsible for taking care of my healthDisagree stronglyDisagreeAgreeAgree stronglyN/A2Taking an active role in my own health care is the most important thing that affects my healthDisagree stronglyDisagreeAgreeAgree stronglyN/A3I am confident I can help prevent or reduce problems associated with my healthDisagree stronglyDisagreeAgreeAgree stronglyN/A4I know what each of my prescribed medications doDisagree stronglyDisagreeAgreeAgree stronglyN/A5I am confident that I can tell whether I need to go to the doctor or whether I can take care of a health problem myselfDisagree stronglyDisagreeAgreeAgree stronglyN/A6I am confident that I can tell a doctor concerns I have even when he or she does not askDisagree stronglyDisagreeAgreeAgree stronglyN/A7I am confident that I can follow through on medical treatments I may need to do at homeDisagree stronglyDisagreeAgreeAgree stronglyN/A8I understand my health problems and what causes themDisagree stronglyDisagreeAgreeAgree stronglyN/A9I know what treatments are available for my health problemsDisagree stronglyDisagreeAgreeAgree stronglyN/A10I have been able to maintain (keep up with) lifestyle changes, like eating right or exercisingDisagree stronglyDisagreeAgreeAgree stronglyN/A11I know how to prevent problems with my healthDisagree stronglyDisagreeAgreeAgree stronglyN/A12I am confident I can figure out solutions when new problems arise with my healthDisagree stronglyDisagreeAgreeAgree stronglyN/A13I am confident that I can maintain lifestyle changes, like eating right and exercising, even during times of stressDisagree stronglyDisagreeAgreeAgree stronglyN/A
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Level 1 They do not feel responsible for their own health and care. Health management is overwhelming for them, considering all the problems of life. They lack confidence in their ability to manage health. They have few solving problem skills and poor coping skills. They may not be fully aware of their behaviour (Score 47.0 or lower).
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Level 2 They may lack basic understanding about their condition, treatment options, and/or self-care. They have little experience making decisions. They consider their doctor as the decision maker. They have little confidence in their ability to manage their health (47.1–55.1).
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Level 3 They know the basic facts of their illness and treatments. They have some experience making decisions and some confidence in the management of certain aspects of their health (55.2–67).
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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).
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MLWHFQ Questionnaire (Minnesota Living with Heart Failure Questionnaire) [17]: validated to analyze the quality of life in patients with HF (Spanish version). Scoring range: 0 to 105 points: The higher the score obtained, the poorer the quality of life of patients. Patients wonder to what extent their illness has prevented them from living the way they wanted last month. 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 MLWHFQ score is obtained by adding the 21 items scores (range: 0–105); the highest value corresponds to the worst HRQL. 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).
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Zarit questionnaire about caregiver's burden [18]. 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:
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or < 45 points: no overload
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47–55 points: slight overload
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or > 55 points: intense overload
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Patient's wishes checklist: Checklist to test the fulfilment of planned patient's wishes. Two parameters (patient participation in the decision-making thought PAM Test and fulfilment of their wishes) allow us to determine whether decision-making in advanced HF is actually being effective.
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Satisfaction questionnaire (Table 3): 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.Table 3Satisfaction questionnaireAnswer YES or NOYESNODid 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?
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Dying and Death quality questionnaire (QODD) [19]: This questionnaire measures the quality of the dying process. It will be submitted to the relatives of patients who passed away during the year of follow-up.