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NCT Number: NCT04662762

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

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

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Key information

Conditions

Medication Adherence Behavior Cardiovascular Diseases Health Behavior Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nursing intervention programme

Other

educational information

Primary outcomes

  1. Number of patients with therapeutic adherence

    Time frame: 12 months after admission

    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.

Secondary outcomes

  1. Rate of readmission,

    Time frame: During the 12 months after the admission

    Need for hospital readmission

  2. Rate of visits to the emergency room

    Time frame: During the 12 months after the admission

    Need for emergency visits at hospital

  3. Rate of mortality

    Time frame: During the 12 months after the admission

    Deaths of cardiac origin were those caused by myocardial infarction, sudden death or heart failure.

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 10, 2020
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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