Noncommunicable DiseasesNCT05469581
"Efficiency of Preventive Interventions in Community Nursing to Improve Medication Adherence in Vulnerable Elderly"
A study testing A set of preventive interventions to improve adherence in vulnerable elderly people in people with Noncommunicable Diseases and Vulnerable Elderly, run by Martina Horvat at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Noncommunicable Diseases, Vulnerable Elderly
- What is being tested?
- A set of preventive interventions to improve adherence in vulnerable elderly people
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 639 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University of Maribor, Faculty of Health Sciences
Maribor, Styria, 2000
About this study
Official title: 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.
Read the 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.
- Conditions
- Noncommunicable Diseases, Vulnerable Elderly
- Being tested
- A set of preventive interventions to improve adherence in vulnerable elderly people
- Keywords
- Adherence, Medication, Preventive Interventions, Community Nursing, Vulnerable Elderly
- Medical subject headings
- Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A set of preventive interventions to improve adherence in vulnerable elderly peopleOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: From date of randomization until final check of changes in adherence and self-efficacy, assessed up to 30 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Sep 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Noncommunicable DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to two groups: experimental and control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 639 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martina Horvat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Martina Horvat, University Maribor
- Investigators
- Martina Horvat, Principal investigator, University of Maribor, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469581
- Sponsor's protocol ID
- 39641
- Status last verified
- May 2023
- First submitted
- 3 Jul 2022
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16843634Risser 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.
PubMed 18232619
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Preventive Interventions in Community Nursing to Improve Medication Adherence in Vulnerable Elderly"
- ClinicalTrials.gov ID
- NCT05469581
- Acronym / sponsor ID
- 39641
- Conditions
- Noncommunicable Diseases, Vulnerable Elderly
- Keywords
- Adherence, Medication, Preventive Interventions, Community Nursing, Vulnerable Elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 639 participants (estimated)
- Lead sponsor
- Martina HorvatUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to two groups: experimental and control.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: A set of preventive interventions to improve adherence in vulnerable elderly peopleInterventions 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. |
| Control group | No intervention | –Interventions to be administered: - review of the list of medication, delivery of an ordered list of medication, and counseling |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intervention group |
Primary outcome
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Background: PubMed 16843634George 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.
- Background: PubMed 18232619Risser 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martina Horvat principal investigator
University of Maribor, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A set of preventive interventions to improve adherence in vulnerable elderly people in people with Noncommunicable Diseases and Vulnerable Elderly, run by Martina Horvat at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adherence (time frame: From date of randomization until final check of changes in adherence and self-efficacy, assessed up to 30 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05469581, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.