Medication AdherenceAMPaRARNCT01978925
Pharmaceutical Care in Emergency Department
A study testing Pharmaceutical care in people with Medication Adherence and Hypertension, 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 patient discharge in an emergency department in patients with hypertension and/or diabetes mellitus type 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Hypertension, Diabetes Mellitus
- What is being tested?
- Pharmaceutical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2013to Dec 2014
- 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
- Blood pressure inadequate control (systolic blood pressure ≥ 160 or diastolic blood pressure ≥ 100 mmHg) or
- Diabetes mellitus inadequate Control( ≥ 200 mg/dL) or hypoglycemia moderate or severe
- Be referred to clinical care.
Who cannot join
- < 18 years
- Not resident of Porto Alegre
- Diabetes mellitus type I
- Unable to answer the questionnaire or to sign the informed consent form
- Hospital admission
- Death
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Emergency Department - Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 900350-001
About this study
Official title: Effectiveness Pharmaceutical Care at Discharge in the Emergency Department: a Randomized Controlled Trial
The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared to usual care, in patient discharge in an emergency department in patients with hypertension and/or diabetes mellitus type 2.
Read the detailed description
This is a randomized controlled, single-center study, with blinding of outcome assessors. A pilot study with ten patients was previously conducted in order to test study logistics and data collection instruments. Participants will be recruited from a public ED at Restinga district in Porto Alegre, southern Brazil.
- Conditions
- Medication Adherence, Hypertension, Diabetes Mellitus
- Being tested
- Pharmaceutical care
- Keywords
- Pharmaceutical care, Medication Adherence, Blood Pressure, Diabetes, Emergency
- Medical subject headings
- Medication Adherence, Hypertension, Diabetes Mellitus, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical careOther
The clinical pharmacist will provide a structured 30-minute intervention for enhancing their medication adherence.
The recommendations include: discussion on hypertension and/or diabetes, risk of complications, prescribed drug therapy, correct use of medications and proper dosage, possible adverse effects, route of administration, schedule of administration and correct storage. The pharmacist will also emphasize the importance of lifestyle modifications. Printed educational material, with information on hypertension and/ or diabetes medications, including suggested lifestyle interventions was prepared to assist in the intervention and will be handed to patients in the end of the session.
| Study group | Role | What they receive |
|---|---|---|
| Pharmaceutical care | Experimental | In the ED, immediately after discharge, participants randomized to the pharmaceutical care group will receive intervention coordinated by the study pharmacist. Receives: Other: Pharmaceutical care |
| Usual care | No intervention | In addition to counseling provided by a physician and by the nursing staff during their stay in the ED (usual care), patients randomized to the control group will receive the same printed material information on hypertension and/or diabetes medications and lifestyle interventions in order to keep patients masked. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Outcome of interest: High Adherence According to the Brief Medication Questionnaire and Morisky-Green Test
Measured: Two months
Secondary outcomes (3)
Blood Pressure Control
Measured: Two months
Glycated hemoglobin (HbA1C) for diabetic patients
Measured: two months
Quality of Life
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionDec 2014
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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Sponsor
- Investigators
- Rodrigo A Ribeiro, PhD, Principal investigator, Hospital Moinhos de Vento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978925
- Sponsor's protocol ID
- AMPaRAR 01
- Acronym
- AMPaRAR
- Status last verified
- May 2015
- First submitted
- 1 Nov 2013
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kuhmmer R, Lima KM, Ribeiro RA, Hammes LS, Bastos GA, Cotta de Souza MC, Polanczyk CA, Soares Rollin GA, Caon S, Guterres CM, Araujo Leite LE, Delabary TS, Falavigna M. Effectiveness of pharmaceutical care at discharge in the emergency department: study protocol of a randomized controlled trial. Trials. 2015 Feb 25;16:60. doi: 10.1186/s13063-015-0579-3.
PubMed 25888343
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Pharmaceutical Care at Discharge in the Emergency Department: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01978925
- Acronym / sponsor ID
- AMPaRAR / AMPaRAR 01
- Conditions
- Medication Adherence, Hypertension, Diabetes Mellitus
- Keywords
- Pharmaceutical care, Medication Adherence, Blood Pressure, Diabetes, Emergency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Nov 2013 (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 patient discharge in an emergency department in patients with hypertension and/or diabetes mellitus type 2.
Detailed description
This is a randomized controlled, single-center study, with blinding of outcome assessors. A pilot study with ten patients was previously conducted in order to test study logistics and data collection instruments. Participants will be recruited from a public ED at Restinga district in Porto Alegre, southern Brazil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmaceutical care | Experimental | Other: Pharmaceutical careIn the ED, immediately after discharge, participants randomized to the pharmaceutical care group will receive intervention coordinated by the study pharmacist. |
| Usual care | No intervention | –In addition to counseling provided by a physician and by the nursing staff during their stay in the ED (usual care), patients randomized to the control group will receive the same printed material information on hypertension and/or diabetes medications and lifestyle interventions in order to keep patients masked. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Blood pressure inadequate control (systolic blood pressure ≥ 160 or diastolic blood pressure ≥ 100 mmHg) or
- Diabetes mellitus inadequate Control( ≥ 200 mg/dL) or hypoglycemia moderate or severe
- Be referred to clinical care.
Key exclusion criteria (6 listed)
- < 18 years
- Not resident of Porto Alegre
- Diabetes mellitus type I
- Unable to answer the questionnaire or to sign the informed consent form
- Hospital admission
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 careThe clinical pharmacist will provide a structured 30-minute intervention for enhancing their medication adherence. The recommendations include: discussion on hypertension and/or diabetes, risk of complications, prescribed drug therapy, correct use of medications and proper dosage, possible adverse effects, route of administration, schedule of administration and correct storage. The pharmacist will also emphasize the importance of lifestyle modifications. Printed educational material, with information on hypertension and/ or diabetes medications, including suggested lifestyle interventions was prepared to assist in the intervention and will be handed to patients in the end of the session. | Other | Pharmaceutical care |
Primary outcome
Medication Adherence
Time frame: Two months
Outcome of interest: High Adherence According to the Brief Medication Questionnaire and Morisky-Green Test
3 secondary outcomes
Blood Pressure Control
Time frame: Two months
Glycated hemoglobin (HbA1C) for diabetic patients
Time frame: two months
Quality of Life
Time frame: Two 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 20 May 2015.
- Derived from this study: PubMed 25888343Kuhmmer R, Lima KM, Ribeiro RA, Hammes LS, Bastos GA, Cotta de Souza MC, Polanczyk CA, Soares Rollin GA, Caon S, Guterres CM, Araujo Leite LE, Delabary TS, Falavigna M. Effectiveness of pharmaceutical care at discharge in the emergency department: study protocol of a randomized controlled trial. Trials. 2015 Feb 25;16:60. doi: 10.1186/s13063-015-0579-3.
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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.
Rodrigo A Ribeiro, PhD 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 Hypertension, 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 6 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 20 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?
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?
Medication Adherence (time frame: Two 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 NCT01978925, 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 20 May 2015.