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

Primary Purpose

Noncommunicable Diseases, Vulnerable Elderly

Status
Active
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
A set of preventive interventions to improve adherence in vulnerable elderly people
Sponsored by
Martina Horvat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Noncommunicable Diseases focused on measuring Adherence, Medication, Preventive Interventions, Community Nursing, Vulnerable Elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Maribor, Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Full Information

First Posted
July 3, 2022
Last Updated
May 15, 2023
Sponsor
Martina Horvat
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1. Study Identification

Unique Protocol Identification Number
NCT05469581
Brief Title
"Efficiency of Preventive Interventions in Community Nursing to Improve Medication Adherence in Vulnerable Elderly"
Official Title
Efficiency of Preventive Interventions in Community Nursing to Improve Medication Adherence in Vulnerable Elderly"
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Martina Horvat

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noncommunicable Diseases, Vulnerable Elderly
Keywords
Adherence, Medication, Preventive Interventions, Community Nursing, Vulnerable Elderly

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomly assigned to two groups: experimental and control.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
639 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Interventions to be administered: - review of the list of medication, delivery of an ordered list of medication, and counseling
Intervention Type
Other
Intervention Name(s)
A set of preventive interventions to improve adherence in vulnerable elderly people
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in adherence
Description
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).
Time Frame
From date of randomization until final check of changes in adherence and self-efficacy, assessed up to 30 weeks.
Title
Change in self-efficacy
Description
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).
Time Frame
From date of randomization until final check of changes in adherence and self-efficacy, assessed up to 30 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martina Horvat
Organizational Affiliation
University of Maribor, Faculty of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maribor, Faculty of Health Sciences
City
Maribor
State/Province
Styria
ZIP/Postal Code
2000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16843634
Citation
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.
Results Reference
background
PubMed Identifier
18232619
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.
Results Reference
background

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

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