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

NCT05469581 | Unknown

• 1 other identifier: 39641
• Study Type: interventional
• Target: 639
• Locations: 1 country
• Sites: 1

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.

Conditions

Noncommunicable Diseases; Vulnerable Elderly

Keywords

Adherence; Medication; Preventive Interventions; Community Nursing; Vulnerable Elderly

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

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): * 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

Control group

NO INTERVENTION

Interventions to be administered: \- review of the list of medication, delivery of an ordered list of medication, and counseling

Interventions

A set of preventive interventions to improve adherence in vulnerable elderly people OTHER

* 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.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Martina Horvat: lead

Study Sites (1)

University of Maribor, Faculty of Health Sciences

Maribor, Styria, 2000, Slovenia

Location

Related 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.

  PMID: 16843634 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.

  PMID: 18232619 BACKGROUND

MeSH Terms

Conditions

Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martina Horvat

  University of Maribor, Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: RN, community nursing specialist, PhD student/candidat

Model Details: Participants were randomly assigned to two groups: experimental and control.

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 21, 2022
• Study Start: September 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)