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

Noncommunicable Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05469581
• Other study ID #: 39641
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University Maribor
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 639
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Noncommunicable Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Slovenia	University of Maribor, Faculty of Health Sciences	Maribor	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Martina Horvat

Country where clinical trial is conducted

Slovenia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.