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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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):
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| Control group | No Intervention | Interventions to be administered: - review of the list of medication, delivery of an ordered list of medication, and counseling |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A set of preventive interventions to improve adherence in vulnerable elderly people | Other |
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| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martina Horvat | University of Maribor, Faculty of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maribor, Faculty of Health Sciences | Maribor | Styria | 2000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16843634 | Background | 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. | |
| 18232619 | Background | 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. |
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Participants were randomly assigned to two groups: experimental and control.
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| ID | Term |
|---|---|
| D000073296 | Noncommunicable Diseases |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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