Cardiovascular Diseases in Old AgeNCT04778891
The Impact of Comprehensive Medication Management Services on Clinical Outcomes in Patients With Cardiovascular Diseases at Primary Care Level
A study testing Comprehensive Medication Management services in people with Cardiovascular Diseases in Old Age, run by University of Zagreb at 2 sites in Croatia.
Trial summary
Patients with established cardiovascular disease (CVD) often have multiple medications that increase the risk of prevalence of drug therapy problems (DTP), subsequently leading to unfavourable clinical and health outcomes. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Cardiovascular Diseases in Old Age
- What is being tested?
- Comprehensive Medication Management services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 2 sitesCroatia
- Study dates
- 8 Jan 2018to 17 Jan 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hypertension
- Established cardiovascular disease
Who cannot join
- Organic, including symptomatic, mental disorders
- Mental and behavioural disorders due to psychoactive substance use
- Schizophrenia, schizotypal and delusional disorders
- Behavioural syndromes associated with physiological disturbances and physical factors
- Disorders of adult personality and behaviour
- Mental retardation
- Disorders of psychological development
Trial locations and contacts
2 sites in 1 country.
Croatia2 sites
Health Care Centre Zagreb - Centre
Zagreb, 10000
University of Zagreb Faculty of Pharmacy and Biochemistry
Zagreb, 10000
About this study
Patients with established cardiovascular disease (CVD) often have multiple medications that increase the risk of prevalence of drug therapy problems (DTP), subsequently leading to unfavourable clinical and health outcomes. By providing Comprehensive Medication Management (CMM) services to patients within a healthcare system, pharmacists assess patients' medication-related needs, identify and prevent DTP, develop individualized care plan for each individual patient and evaluate and monitor outcomes. Thus, the CMM services delivered at the primary care level in collaboration with general practitioners and other healthcare providers could address this problem and by optimizing therapy improve patients' clinical outcomes and quality of life. Studies have shown that patients with chronic diseases have the greatest benefit from the CMM services. The aim of this study is to evaluate the impact of CMM services on clinical and humanistic outcomes in patients with established CVD. The study will employ prospective, longitudinal, pre- and postintervention study with a 1-year patient follow-up.
- Conditions
- Cardiovascular Diseases in Old Age
- Being tested
- Comprehensive Medication Management services
- Keywords
- medication managements services, pharmaceutical care, primary care, elderly, control group, cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Medication Management servicesOther
Comprehensive Medication Management services (CMM services) is an evidence-based and patient-centred service which involves an assessment of patient's medications to determine that each medication is appropriate, effective for the medical condition being treated, safe for the patient in the presence of other medications and co-morbidities, and that the patient is able and willing to take the medications as intended. As all patient care providers need a structured, rational thought process for sound clinical decision retrieval, the Pharmacotherapy Workup was developed and adopted as a systematic problem-solving process. This process represents the cognitive work taking place in the mind of the practitioner, and is used to identify, resolve, and prevent drug therapy problems (DTP), establish therapy goals, select interventions and evaluate outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | In addition to usual care provided by general practitioner (GP) and other health care providers, a pharmacist-practitioner in collaboration with GPs from the study setting provided CMM services to patients in the intervention group. Based on the pre-defined inclusion criteria, GPs were selecting patients and referring them to the pharmacist. The individual consultation with the patient was held at the private counselling area where pharmacist and patient were able to talk face-to-face apart from the other patients. The initial assessment lasted 60-90 minutes and the follow-up evaluations 30-60 minutes. Alternatively, patients were followed-up by telephone. Communication with GPs took place in a written (electronic consultation system Health net. PRO; e-mail) and, if needed by face-to-face conversation. Each patient in the intervention group needed to agree to participate in the study by signing an Informed consent form. Receives: Other: Comprehensive Medication Management services |
| Control group | No intervention | Patients in the control group received the usual care which includes GP and other health care provider visits. Data for the patients pertaining to the control group were provided by the 'control' GP and collected parallel with the intervention group. 'Control' GP profile corresponded to the profile of GPs included in the intervention group - the number of years of professional experience in the primary health care less than ten. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of CMM services on blood pressure in elderly patients with established CVD
Within- and between-treatment differences for the intervention and the control group in blood pressure.
Measured: 1 year
Secondary outcomes (5)
The impact of CMM services on LDL cholesterol, triglycerides, HDL cholesterol and total cholesterol in elderly patients with established CVD
Within- and between-treatment differences for the intervention and the control group in LDL cholesterol (mmol/L), triglycerides (mmol/L), HDL cholesterol (mmol/L) and total cholesterol (mmol/L).
Measured: 1 year
The impact of CMM services on health care utilization in elderly patients with established CVD
Between-treatment difference in the number of hospital admissions, emergency department visits and unplanned GPs visits.
Measured: 1 year
The impact of CMM services on drug therapy problems in elderly patients with established CVD
Number and type of drug therapy problems in the intervention group.
Measured: 1 year
The impact of CMM services on health related quality of life in elderly patients with established CVD assessed by EQ-5D-5L instrument.
Change from baseline in health related quality of life assessed by EQ-5D-5L instrument in the intervention group.
Measured: 1 year
The impact of CMM services on glycated haemoglobin in elderly patients with established CVD
Within- and between-treatment differences for the intervention and the control group in glycated haemoglobin.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start8 Jan 2018
- Primary completion17 Jan 2021
- Study completion17 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Diseases in Old AgeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- Health Centre Zagreb - Centre (Dom zdravlja Zagreb - Centar)
- Responsible party
- Principal investigator, Iva Mucalo, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778891
- Sponsor's protocol ID
- 380-130/134-20-2
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramalho de Oliveira D, Brummel AR, Miller DB. Medication therapy management: 10 years of experience in a large integrated health care system. J Manag Care Pharm. 2010 Apr;16(3):185-95. doi: 10.18553/jmcp.2010.16.3.185.
PubMed 20331323Strand LM, Cipolle RJ, Morley PC, Frakes MJ. The impact of pharmaceutical care practice on the practitioner and the patient in the ambulatory practice setting: twenty-five years of experience. Curr Pharm Des. 2004;10(31):3987-4001. doi: 10.2174/1381612043382576.
PubMed 15579084Brummel A, Carlson AM. Comprehensive Medication Management and Medication Adherence for Chronic Conditions. J Manag Care Spec Pharm. 2016 Jan;22(1):56-62. doi: 10.18553/jmcp.2016.22.1.56.
PubMed 27015052Cranor CW, Bunting BA, Christensen DB. The Asheville Project: long-term clinical and economic outcomes of a community pharmacy diabetes care program. J Am Pharm Assoc (Wash). 2003 Mar-Apr;43(2):173-84. doi: 10.1331/108658003321480713.
PubMed 12688435Bunting BA, Smith BH, Sutherland SE. The Asheville Project: clinical and economic outcomes of a community-based long-term medication therapy management program for hypertension and dyslipidemia. J Am Pharm Assoc (2003). 2008 Jan-Feb;48(1):23-31. doi: 10.1331/JAPhA.2008.07140.
PubMed 18192127Brajkovic A, Mucalo I, Vidovic T, Gonzaga MM, Nascimento D, Balenovic A, Protrka I, De Oliveira DR. Implementation of medication management services at the primary healthcare level - a pilot study. Acta Pharm. 2019 Dec 1;69(4):585-606. doi: 10.2478/acph-2019-0055.
PubMed 31639091
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Comprehensive Medication Management Services on Clinical Outcomes in Patients With Cardiovascular Diseases at Primary Care Level
- ClinicalTrials.gov ID
- NCT04778891
- Acronym / sponsor ID
- 380-130/134-20-2
- Conditions
- Cardiovascular Diseases in Old Age
- Keywords
- medication managements services, pharmaceutical care, primary care, elderly, control group, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Collaborators
- Health Centre Zagreb - Centre (Dom zdravlja Zagreb - Centar)
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 17 Jan 2021 (actual)
- Study completion
- 17 Jan 2021 (actual)
- First posted
- 3 Mar 2021 (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.
Patients with established cardiovascular disease (CVD) often have multiple medications that increase the risk of prevalence of drug therapy problems (DTP), subsequently leading to unfavourable clinical and health outcomes. By providing Comprehensive Medication Management (CMM) services to patients within a healthcare system, pharmacists assess patients' medication-related needs, identify and prevent DTP, develop individualized care plan for each individual patient and evaluate and monitor outcomes. Thus, the CMM services delivered at the primary care level in collaboration with general practitioners and other healthcare providers could address this problem and by optimizing therapy improve patients' clinical outcomes and quality of life. Studies have shown that patients with chronic diseases have the greatest benefit from the CMM services. The aim of this study is to evaluate the impact of CMM services on clinical and humanistic outcomes in patients with established CVD. The study will employ prospective, longitudinal, pre- and postintervention study with a 1-year patient follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Comprehensive Medication Management servicesIn addition to usual care provided by general practitioner (GP) and other health care providers, a pharmacist-practitioner in collaboration with GPs from the study setting provided CMM services to patients in the intervention group. Based on the pre-defined inclusion criteria, GPs were selecting patients and referring them to the pharmacist. The individual consultation with the patient was held at the private counselling area where pharmacist and patient were able to talk face-to-face apart from the other patients. The initial assessment lasted 60-90 minutes and the follow-up evaluations 30-60 minutes. Alternatively, patients were followed-up by telephone. Communication with GPs took place in a written (electronic consultation system Health net. PRO; e-mail) and, if needed by face-to-face conversation. Each patient in the intervention group needed to agree to participate in the study by signing an Informed consent form. |
| Control group | No intervention | –Patients in the control group received the usual care which includes GP and other health care provider visits. Data for the patients pertaining to the control group were provided by the 'control' GP and collected parallel with the intervention group. 'Control' GP profile corresponded to the profile of GPs included in the intervention group - the number of years of professional experience in the primary health care less than ten. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Hypertension
- Established cardiovascular disease
Key exclusion criteria (7 listed)
- Organic, including symptomatic, mental disorders
- Mental and behavioural disorders due to psychoactive substance use
- Schizophrenia, schizotypal and delusional disorders
- Behavioural syndromes associated with physiological disturbances and physical factors
- Disorders of adult personality and behaviour
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 |
|---|---|---|
| Comprehensive Medication Management servicesComprehensive Medication Management services (CMM services) is an evidence-based and patient-centred service which involves an assessment of patient's medications to determine that each medication is appropriate, effective for the medical condition being treated, safe for the patient in the presence of other medications and co-morbidities, and that the patient is able and willing to take the medications as intended. As all patient care providers need a structured, rational thought process for sound clinical decision retrieval, the Pharmacotherapy Workup was developed and adopted as a systematic problem-solving process. This process represents the cognitive work taking place in the mind of the practitioner, and is used to identify, resolve, and prevent drug therapy problems (DTP), establish therapy goals, select interventions and evaluate outcomes. | Other | Intervention group |
Primary outcome
The impact of CMM services on blood pressure in elderly patients with established CVD
Time frame: 1 year
Within- and between-treatment differences for the intervention and the control group in blood pressure.
5 secondary outcomes
The impact of CMM services on LDL cholesterol, triglycerides, HDL cholesterol and total cholesterol in elderly patients with established CVD
Time frame: 1 year
The impact of CMM services on health care utilization in elderly patients with established CVD
Time frame: 1 year
The impact of CMM services on drug therapy problems in elderly patients with established CVD
Time frame: 1 year
The impact of CMM services on health related quality of life in elderly patients with established CVD assessed by EQ-5D-5L instrument.
Time frame: 1 year
The impact of CMM services on glycated haemoglobin in elderly patients with established CVD
Time frame: 1 year
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 3 Mar 2021.
- Background: PubMed 20331323Ramalho de Oliveira D, Brummel AR, Miller DB. Medication therapy management: 10 years of experience in a large integrated health care system. J Manag Care Pharm. 2010 Apr;16(3):185-95. doi: 10.18553/jmcp.2010.16.3.185.
- Background: PubMed 15579084Strand LM, Cipolle RJ, Morley PC, Frakes MJ. The impact of pharmaceutical care practice on the practitioner and the patient in the ambulatory practice setting: twenty-five years of experience. Curr Pharm Des. 2004;10(31):3987-4001. doi: 10.2174/1381612043382576.
- Background: PubMed 27015052Brummel A, Carlson AM. Comprehensive Medication Management and Medication Adherence for Chronic Conditions. J Manag Care Spec Pharm. 2016 Jan;22(1):56-62. doi: 10.18553/jmcp.2016.22.1.56.
- Background: PubMed 12688435Cranor CW, Bunting BA, Christensen DB. The Asheville Project: long-term clinical and economic outcomes of a community pharmacy diabetes care program. J Am Pharm Assoc (Wash). 2003 Mar-Apr;43(2):173-84. doi: 10.1331/108658003321480713.
- Background: PubMed 18192127Bunting BA, Smith BH, Sutherland SE. The Asheville Project: clinical and economic outcomes of a community-based long-term medication therapy management program for hypertension and dyslipidemia. J Am Pharm Assoc (2003). 2008 Jan-Feb;48(1):23-31. doi: 10.1331/JAPhA.2008.07140.
- Results publication: PubMed 31639091Brajkovic A, Mucalo I, Vidovic T, Gonzaga MM, Nascimento D, Balenovic A, Protrka I, De Oliveira DR. Implementation of medication management services at the primary healthcare level - a pilot study. Acta Pharm. 2019 Dec 1;69(4):585-606. doi: 10.2478/acph-2019-0055.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Medication Management services in people with Cardiovascular Diseases in Old Age, run by University of Zagreb at 2 sites in Croatia.
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 2 inclusion and 7 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 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia. 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?
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?
The impact of CMM services on blood pressure in elderly patients with established CVD (time frame: 1 year). 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 NCT04778891, which also lists 6 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 3 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.