Medication AdherenceNCT02452788
Pharmaceutical Care in Ambulatory Hemodialysis Patients
A study testing Pharmaceutical care in people with Medication Adherence and Chronic Renal Diseases, run by Hospital Moinhos de Vento at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared to usual care, in improving medication adherence behaviour of ambulatory hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Chronic Renal Diseases, Renal Failure Chronic Requiring Hemodialysis
- What is being tested?
- Pharmaceutical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- May 2015to Jul 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or more
- Chronic renal patients undergoing regular hemodialysis
- Receiving their scheduled medications (at least one drug)
Who cannot join
- Unable to answer the questionnaire or to sign the informed consent form
- Inability to obtain prescription drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001
About this study
Official title: Effectiveness of Pharmaceutical Care in Ambulatory Hemodialysis Patients: a Randomized Controlled Pilot Study
The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared to usual care, in improving medication adherence behaviour of ambulatory hemodialysis patients.
- Conditions
- Medication Adherence, Chronic Renal Diseases, Renal Failure Chronic Requiring Hemodialysis
- Being tested
- Pharmaceutical care
- Medical subject headings
- Medication Adherence, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical careOther
Pharmacist-provided education on medication adherence in hemodialysis patients.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Pharmaceutical care with educational intervention provided by a pharmacist to ambulatory hemodialysis patients Receives: Other: Pharmaceutical care |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
High adherence according to the Brief Medication Questionnaire
Measured: one month
Secondary outcomes (1)
Quality of life
Quality of life will be evaluated with EQ-5D questionnaire
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisiane F Leal, MBA, Principal investigator, Hospital Moinhos de Vento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452788
- Sponsor's protocol ID
- AMhem-01
- Status last verified
- May 2015
- First submitted
- 19 May 2015
- Last updated
- 25 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pharmaceutical Care in Ambulatory Hemodialysis Patients: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02452788
- Acronym / sponsor ID
- AMhem-01
- Conditions
- Medication Adherence, Chronic Renal Diseases, Renal Failure Chronic Requiring Hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2015 (estimated)
- First posted
- 25 May 2015 (estimated)
- 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 this study is to evaluate the effectiveness of pharmaceutical care, compared to usual care, in improving medication adherence behaviour of ambulatory hemodialysis patients.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Pharmaceutical carePharmaceutical care with educational intervention provided by a pharmacist to ambulatory hemodialysis patients |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or more
- Chronic renal patients undergoing regular hemodialysis
- Receiving their scheduled medications (at least one drug)
Key exclusion criteria (2 listed)
- Unable to answer the questionnaire or to sign the informed consent form
- Inability to obtain prescription drugs
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 |
|---|---|---|
| Pharmaceutical carePharmacist-provided education on medication adherence in hemodialysis patients. | Other | Intervention |
Primary outcome
Medication adherence
Time frame: one month
High adherence according to the Brief Medication Questionnaire
1 secondary outcome
Quality of life
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
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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.
Lisiane F Leal, MBA principal investigator
Hospital Moinhos de Vento
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical care in people with Medication Adherence and Chronic Renal Diseases, run by Hospital Moinhos de Vento at 1 site in Brazil.
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 2 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 25 May 2015. 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 Brazil. 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?
Contact Maicon Falavigna, PhD (+555133143600, maicon.falavigna@hmv.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2015.