"Efficiency of Preventive Interventions in Community Nursing to Improve Medication Adherence in Vulnerable Elderly"

Martina Horvat

Status: Active, not recruiting

Conditions: Noncommunicable Diseases; Vulnerable Elderly

Treatments: Other: A set of preventive interventions to improve adherence in vulnerable elderly people

Study type: Interventional

Funder types: Other

Identifiers

NCT05469581

39641

Details and patient eligibility

About

The purpose of the study is to design and investigate the effectiveness of a set of preventive interventions by community nurses in outpatient care in treating vulnerable elderly people to improve the extent to which they follow the agreed recommendations of a doctor or pharmacist regarding taking medication.

Full description

We will conduct a randomized controlled trial to determine the effectiveness of preventive interventions to improve adherence in vulnerable elderly people.

The randomized controlled trial will include: vulnerable people over 65 years of age with preserved cognitive abilities who are receiving at least one medication for any medical condition and are being treated by an outpatient service; they live in their home environment, which in the first phase will show vulnerability and, at the same time, initial suboptimal adherence.

We will inform the subjects verbally and in writing about the course, purpose, and goals of the study and obtain their written consent for inclusion in the study. They will then be randomly assigned to two groups: experimental and control.

In the case of the experimental group, we will carry out a set of preventive interventions to support the improvement of medication adherence. The control group will receive regular nursing care from community nurses, to which we will add the so-called distractor.

We will determine the effectiveness of preventive interventions based on changes in self-efficacy and adherent behavior.

Data on adherence behavior and self-efficacy will be collected at the beginning of the study, at the end of the implementation of the set of preventive interventions, and three months after the end of the implementation.

Enrollment: 639 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• vulnerable elderly 65years and older,
• vulnerable elderly with preserved cognitive abilities,
• vulnerable elderly receiving at least one medication for any medical condition,
• vulnerable elderly treated by a community nurse,
• community-dwelling vulnerable elderly,
• suboptimal adherent vulnerable elderly.

Exclusion criteria

• vulnerable elderly with psychoses or dementia,
• vulnerable elderly with cognitive disorders,
• vulnerable elderly addicted to alcohol,
• vulnerable elderly addicted to illegal drugs,
• vulnerable elderly in the terminal phase of the disease (life expectancy less than 6 months).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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639 participants in 2 patient groups

Intervention group

Experimental group

Description:

Interventions to be administered: A set of preventive interventions to improve adherence in vulnerable elderly people (We will not administer any medications in the research): * reviewing the list of medications, delivery of an ordered list of medications and checking medication regimen understanding; * delivering a leaflet on the correct/safe taking of medication, discussion, explanation, and verification of understanding of the content; * a counseling about the importance of adherence; * handing over the medication dispenser (if the elderly person does not have one yet), * delivering of a personal medication card, which shows the timeline of taking prescribed medication.

Treatment:

Other: A set of preventive interventions to improve adherence in vulnerable elderly people

Control group

No Intervention group

Description:

Interventions to be administered: - review of the list of medication, delivery of an ordered list of medication, and counseling