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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Noncommunicable Diseases, Vulnerable Elderly

Intervention / Treatment
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* Other: A set of preventive interventions to improve adherence in vulnerable elderly people


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants were randomly assigned to two groups: experimental and control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Other: A set of preventive interventions to improve adherence in vulnerable elderly people<br>* 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.<br>|
| No Intervention: Control group<br>Interventions to be administered: - review of the list of medication, delivery of an ordered list of medication, and counseling | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in adherence | Medication adherence will be assessed using the Tool of adherence behavior screening (TABS), which is a part of the Beliefs and Behavior Questionnaire (BBQ) (George, et al., 2006) and is intended to assess adherence and related behaviors, health beliefs, and experiences of patients with chronic diseases. The TABS is a tool that measures patient self-reported adherence (George, et al., 2006). It has two subscales - 'adherence' (statements 2, 3, 4, 5) and 'non-adherence' (statements 1, 6, 7 and 8). Each one contains four statements, to which the respondent decides on a 5-point Likert scale ('never' - 1 to 'always' - 5). We add the points of both subscales and subtract the sum of the points of the subscale 'non-adherence' from the sum of the points of the subscale 'adherence'. In good adherence, the difference is ≥ 15 and in the case of suboptimal adherence, the difference is ≤ 14 (George, et al., 2006). | From date of randomization until final check of changes in adherence and self-efficacy, assessed up to 30 weeks. | 
| Change in self-efficacy | Self-efficacy will be measured using Self-Efficacy for Appropriate Medication Use (SEAMS) consisting of 13 statements/questions and a 3-point Likert scale (Risser, et al., 2007). The higher the number of points collected, the better the self-efficacy (Risser et al., 2007). | From date of randomization until final check of changes in adherence and self-efficacy, assessed up to 30 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Medication, Preventive Interventions, Community Nursing, Vulnerable Elderly