A Nursing Intervention Program to Improve Therapeutic Adherence in Elderly People With Acute Myocardial Infarction

Study Overview
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Brief Summary
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The objective of this study was to assess the impact of a nursing intervention on therapeutic adherence in elderly patients after acute myocardial infarction compared to a control group

Detailed Description
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A comprehensive geriatric assessment was performed during the first admission in all patients. Patients were randomly allocated to a nursing intervention group or a usual care group. In patients from the intervention group, a nursing intervention programme was performed 3 months after admission, based on education, support and patient monitoring to improve therapeutic adherence and a 6 month phone call. The main outcome measured was therapeutic adherence at 12 months, as defined by a combination of adherence measurement tools (Morisky-Green and Hayness-Sacket scales, attendance at visits and withdrawal of medication from the pharmacy). Therapeutic adherence was assessed by nurses blinded to the assignment group.

Official Title
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A Nursing Intervention Program Significantly Improves Therapeutic Adherence in Elderly People With Acute Myocardial Infarction: a Randomized Controlled Study

Conditions
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Medication Adherence, Myocardial Infarction

Intervention / Treatment
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* Other: Nursing intervention programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with STEMI aged 75 years or older underwent primary percutaneous coronary intervention (PCI) Exclusion Criteria: Patients who refused to participate in the study Patients unable to perform geriatric assessment. Patients admitted to nursing homes or social health centres.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were randomly assigned to a nursing intervention group or a usual care group (1:1). Nonprobabilistic, consecutive sampling was carried out with random assignment of the study groups.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nursing intervention group<br>An educational interview by trained nurses was performed at three months in patients allocated to the intervention group. The visit was carried out at the hospital. Family and caregivers were also asked to attend this visit for instruction. For patients unable to move, the nursing team went to their home to perform the intervention, or it was conducted by phone. The duration of this interview was approximately 40 minutes and was focused on some measures and recommendations to improve or maintain adherence. Then, there is a reminder call at 6 months. | Other: Nursing intervention programme<br>* educational information<br>|
| No Intervention: Usual care group<br>The patient is followed up and regular visits | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with therapeutic adherence | The main outcome measured was therapeutic adherence 12 months after admission. The definition of adherence was a single measure taking into account 4 different methods (see below). Patients were considered adherent when the 4 criteria were present (called global adherence).Measurement unit was: Number of patients with therapeutic adherence Morisky-Green Scale (MGLS): consists of a series of four questions with dichotomous answers (yes/no) that affect the patient's behaviour regarding compliance. Self-reported compliance communication: Haynes-Sackett method: involves asking the patient one question. If the answer is affirmative, is considered adherent. Records of dispensations in the pharmacy: Patients who withdrew all medications during the year were considered adherent. Attendance at scheduled appointments: It is recorded if the patient has missed any of the control visits by both the doctor and the nurse during the first year. | 12 months after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of readmission, | Need for hospital readmission | During the 12 months after the admission | 
| Rate of visits to the emergency room | Need for emergency visits at hospital | During the 12 months after the admission | 
| Rate of mortality | Deaths of cardiac origin were those caused by myocardial infarction, sudden death or heart failure. | During the 12 months after the admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Nursing