Clinical trial NCT05469581: "Efficiency of Preventive Interventions in Community Nursing to Improve Medication Adherence in Vulnerable Elderly"
Official title: Efficiency of Preventive Interventions in Community Nursing to Improve Medication Adherence in Vulnerable Elderly"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Noncommunicable Diseases
Vulnerable Elderly
Keywords: Adherence
Medication
Preventive Interventions
Community Nursing
Vulnerable Elderly
Lead sponsor: University Maribor
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 639
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned to two groups: experimental and control.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in adherence
timeFrame: From date of randomization until final check of changes in adherence and self-efficacy, assessed up to 30 weeks.
measure: Change in self-efficacy
timeFrame: From date of randomization until final check of changes in adherence and self-efficacy, assessed up to 30 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Maribor
country: Slovenia
facility: University of Maribor, Faculty of Health Sciences
state: Styria
Study officials:
affiliation: University of Maribor, Faculty of Health Sciences
name: Martina Horvat
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.