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

May 15, 2023 updated by: Martina Horvat

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

639

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
    • Styria
      • Maribor, Styria, Slovenia, 2000
        • University of Maribor, Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

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
  • 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.
No Intervention: Control group

Interventions to be administered:

- review of the list of medication, delivery of an ordered list of medication, and counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in adherence
Time Frame: From date of randomization until final check of changes in adherence and self-efficacy, assessed up to 30 weeks.

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
Time Frame: From date of randomization until final check of changes in adherence and self-efficacy, assessed up to 30 weeks.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martina Horvat

Investigators

  • Principal Investigator: Martina Horvat, University of Maribor, Faculty of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

July 3, 2022

First Submitted That Met QC Criteria

July 19, 2022

First Posted (Actual)

July 21, 2022

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39641

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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