"Efficiency of Preventive Interventions in Community Nursing to Improve Medication Adherence in Vulnerable Elderly"
NCT ID: NCT05469581
Last Updated: 2023-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
639 participants
INTERVENTIONAL
2021-09-01
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Intervention group
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.
A set of preventive interventions to improve adherence in vulnerable elderly people
* 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 medications, 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.
Control group
Interventions to be administered:
\- review of the list of medication, delivery of an ordered list of medication, and counseling
No interventions assigned to this group
Interventions
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A set of preventive interventions to improve adherence in vulnerable elderly people
* 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 medications, 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.
Eligibility Criteria
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Inclusion Criteria
* 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 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).
65 Years
ALL
No
Sponsors
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Martina Horvat
OTHER
Responsible Party
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Martina Horvat
RN, community nursing specialist, PhD student/candidat
Principal Investigators
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Martina Horvat
Role: PRINCIPAL_INVESTIGATOR
University of Maribor, Faculty of Health Sciences
Locations
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University of Maribor, Faculty of Health Sciences
Maribor, Styria, Slovenia
Countries
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References
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George J, Mackinnon A, Kong DC, Stewart K. Development and validation of the Beliefs and Behaviour Questionnaire (BBQ). Patient Educ Couns. 2006 Dec;64(1-3):50-60. doi: 10.1016/j.pec.2005.11.010. Epub 2006 Jul 14.
Risser J, Jacobson TA, Kripalani S. Development and psychometric evaluation of the Self-efficacy for Appropriate Medication Use Scale (SEAMS) in low-literacy patients with chronic disease. J Nurs Meas. 2007;15(3):203-19. doi: 10.1891/106137407783095757.
Other Identifiers
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39641
Identifier Type: -
Identifier Source: org_study_id
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