Atrial FibrillationNCT03212898
Pharmacist Interventions in Rural Elderly Warfarin Patients
A study testing anticoagulation care in people with Atrial Fibrillation and Thrombosis, run by Slaven Falamić.
Trial summary
The primary study goal is to explore the influence of pharmacist interventions on the effectiveness of warfarin treatment in a specific subpopulation. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation, Thrombosis, Cardiac Failure
- What is being tested?
- anticoagulation care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jan 2017
- 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
- Age ≥65 years
- Living site of participant outside the city eg. rural site
- Expected duration of warfarin therapy at least 6 months from the inclusion in the study and 3 months before
Who cannot join
- Hospitalization
- Vegetarianism
- Patients not able to provide an informed consent
- The use of drug that has an X level of clinical significance of interaction with warfarin according to Lexicomp interact base
About this study
Official title: The Influence of Pharmacist Interventions on the Effectiveness of Warfarin Treatment in Elderly Patients From Rural Areas
The primary study goal is to explore the influence of pharmacist interventions on the effectiveness of warfarin treatment in a specific subpopulation.
- Conditions
- Atrial Fibrillation, Thrombosis, Cardiac Failure, Hemorrhage
- Being tested
- anticoagulation care
- Keywords
- pharmacist interventions, warfarin, elderly rural patients
- Medical subject headings
- Atrial Fibrillation, Thrombosis, Heart Failure, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anticoagulation careOther
Patients in the intervention group will: 1) have a repeated pharmacist-led education on all aspects of warfarin treatment; 2) receive enhanced medication instructions and a care and follow up plan; 3) receive a pill box 4) be refered to the GP with proposal for dose change when outside the therapeutic range or therapy modification to avoid drug interactions with warfarin
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Specific pharmacist-led anticoagulation care Receives: Other: anticoagulation care |
| Control | No intervention | The control group will receive usual care; no interventions will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in therapeutic range (TTR)
Time in therapeutic range by Rosendaal method (percentage of time in therapeutic range)
Measured: 6 months
Secondary outcomes (8)
Adverse drug reactions
To measure the difference in number and types of adverse drug reactions between the intervention and the control group
Measured: 6 months
Time to adverse drug reaction
To measure the difference in time to adverse drug reactions between the intervention and the control group
Measured: 6 months
International randomised ratio
To measure the difference in patterns of the International randomised ratio between the intervention and the control group
Measured: 6 months
Adherence
To measure the difference in adherence between the intervention and the control group
Measured: 6 months
Quality of life
To measure the difference of the quality of life in the intervention and the control group at the beginning and the end of the study (validated Croatian version of DUKE - Duke anticoagulation satisfaction scale questionaire)
Measured: 6 months
Incidence and influence of clinically significant drug interactions
To measure the incidence of clinically significant drug interactions (defined by the Lexicomp-interact base as degree C and D of clinical significance) and influence of drug interactions on the effectiveness and safety of treatment between the intervention and the control group
Measured: 6 months
Dietary intake of vitamin K
Changes of dietary intake of vitamin K
Measured: 6 months
Acceptance of pharmacist's intervention by the general practitioners
To measure the rate of acceptance of pharmacist's interventions by the general practitioners
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startMay 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Slaven Falamić
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Slaven Falamić, Slaven Falamić
- Investigators
- Slaven Falamić, MPharm, Principal investigator, Pharmacy Branka Marušić
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212898
- Sponsor's protocol ID
- SFalamic
- Status last verified
- Jul 2017
- First submitted
- 4 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Falamic S, Lucijanic M, Ortner-Hadziabdic M, Marusic S, Bacic-Vrca V. Pharmacists' interventions improve health-related quality of life of rural older person on warfarin: a randomized controlled trial. Sci Rep. 2021 Nov 9;11(1):21897. doi: 10.1038/s41598-021-01394-0.
PubMed 34754004
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Pharmacist Interventions on the Effectiveness of Warfarin Treatment in Elderly Patients From Rural Areas
- ClinicalTrials.gov ID
- NCT03212898
- Acronym / sponsor ID
- SFalamic
- Conditions
- Atrial Fibrillation, Thrombosis, Cardiac Failure, Hemorrhage
- Keywords
- pharmacist interventions, warfarin, elderly rural patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Slaven FalamićUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 Jul 2017 (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 primary study goal is to explore the influence of pharmacist interventions on the effectiveness of warfarin treatment in a specific subpopulation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: anticoagulation careSpecific pharmacist-led anticoagulation care |
| Control | No intervention | –The control group will receive usual care; no interventions will be administered. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥65 years
- Living site of participant outside the city eg. rural site
- Expected duration of warfarin therapy at least 6 months from the inclusion in the study and 3 months before
Key exclusion criteria (4 listed)
- Hospitalization
- Vegetarianism
- Patients not able to provide an informed consent
- The use of drug that has an X level of clinical significance of interaction with warfarin according to Lexicomp interact base
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 |
|---|---|---|
| anticoagulation carePatients in the intervention group will: 1) have a repeated pharmacist-led education on all aspects of warfarin treatment; 2) receive enhanced medication instructions and a care and follow up plan; 3) receive a pill box 4) be refered to the GP with proposal for dose change when outside the therapeutic range or therapy modification to avoid drug interactions with warfarin | Other | Intervention |
Primary outcome
Time in therapeutic range (TTR)
Time frame: 6 months
Time in therapeutic range by Rosendaal method (percentage of time in therapeutic range)
8 secondary outcomes
Adverse drug reactions
Time frame: 6 months
Time to adverse drug reaction
Time frame: 6 months
International randomised ratio
Time frame: 6 months
Adherence
Time frame: 6 months
Quality of life
Time frame: 6 months
Incidence and influence of clinically significant drug interactions
Time frame: 6 months
Dietary intake of vitamin K
Time frame: 6 months
Acceptance of pharmacist's intervention by the general practitioners
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Derived from this study: PubMed 34754004Falamic S, Lucijanic M, Ortner-Hadziabdic M, Marusic S, Bacic-Vrca V. Pharmacists' interventions improve health-related quality of life of rural older person on warfarin: a randomized controlled trial. Sci Rep. 2021 Nov 9;11(1):21897. doi: 10.1038/s41598-021-01394-0.
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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.
Slaven Falamić, MPharm principal investigator
Pharmacy Branka Marušić
Questions about this trial
What is this clinical trial studying?
A study testing anticoagulation care in people with Atrial Fibrillation and Thrombosis, run by Slaven Falamić.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time in therapeutic range (TTR) (time frame: 6 months). 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 NCT03212898, which also lists 1 linked publication.
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 11 Jul 2017.