A Nursing Intervention Program to Improve Therapeutic Adherence in Elderly People With Acute Myocardial Infarction
1 other identifier
interventional
160
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2020
CompletedFirst Submitted
Initial submission to the registry
November 28, 2020
CompletedFirst Posted
Study publicly available on registry
December 10, 2020
CompletedDecember 14, 2020
December 1, 2020
3.9 years
November 28, 2020
December 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Rate of readmission,
During the 12 months after the admission
Rate of visits to the emergency room
During the 12 months after the admission
Rate of mortality
During the 12 months after the admission
Study Arms (2)
nursing intervention group
EXPERIMENTALAn 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.
Usual care group
NO INTERVENTIONThe patient is followed up and regular visits
Interventions
Eligibility Criteria
You may qualify if:
- Patients with STEMI aged 75 years or older underwent primary percutaneous coronary intervention (PCI)
You may not qualify if:
- Patients who refused to participate in the study
- Patients unable to perform geriatric assessment.
- Patients admitted to nursing homes or social health centres.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Calvo E, Izquierdo S, Castillo R, Cesar E, Domene G, Gomez AB, Guerrero C, Andreu-Periz L, Gomez-Hospital JA, Ariza-Sole A. Can an individualized adherence education program delivered by nurses improve therapeutic adherence in elderly people with acute myocardial infarction?: A randomized controlled study. Int J Nurs Stud. 2021 Aug;120:103975. doi: 10.1016/j.ijnurstu.2021.103975. Epub 2021 May 10.
PMID: 34102371DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elena Calvo, RN
Nurse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The random assignment was made to the "nursing intervention group" and the "usual care group", generating a list using the EPIDAT ® programme. This list contained the patient number and the assignment group. The randomization procedure was performed during hospitalization for AMI. The researcher did not know the assignment list, calling the research unit at the time of each patient inclusion by phone, when they were told to which group they would belong to once the first interview was over. The main outcome measured was therapeutic adherence 12 months after admission. This assessment was performed by trained nurses blinded to the group assignment.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
November 28, 2020
First Posted
December 10, 2020
Study Start
April 1, 2016
Primary Completion
February 28, 2020
Study Completion
May 28, 2020
Last Updated
December 14, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share