HypertensionCELESTENCT06108674
Telepharmacy on Patients With Arterial Hypertension
A study of Hypertension, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to compare the effectiveness of a pharmaceutical care protocol via teleconsultation in the management of uncontrolled hypertension with pharmaceutical care carried out in elderly patients assisted in primary health care. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypertension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2023to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patients admitted to the service with a diagnosis of systemic arterial hypertension made by a physician based on a patient report, report or medical prescription.
- Patients who present uncontrolled blood pressure at the time of assessment based on the average of three measurements using a standardized protocol at the pharmacy will be included;
- Patients must have a cell phone and know how to use it;
- Patient not have previously received pharmaceutical care.
Who cannot join
- Elderly people who are unable to use their cell phones due to cognitive impairments (Mini Mental State Examination (MMSE).
- Elderly person considered unable of using a telephone (Instrumental Activities of Daily Living)
- Elderly with controlled blood pressure according to home monitoring.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Farmácia Escola da UFBA, campus Anísio Teixeira
Vitória da Conquista, Estado de Bahia, 45028440
Marcio Galvão Oliveira, PhD, 55 77 988280954, mgalvao@ufba.br
Márcio Galvão Oliveira, PhD
About this study
Official title: Evaluation of the Effectiveness of Telepharmacy on Clinical Outcomes of Patients With Arterial Hypertension: Celeste Randomized Clinical Trial
The goal of this clinical trial is to compare the effectiveness of a pharmaceutical care protocol via teleconsultation in the management of uncontrolled hypertension with pharmaceutical care carried out in elderly patients assisted in primary health care. The main questions it aims to answer are:
- How effective is a pharmaceutical care protocol via teleconsultation on the clinical outcomes of elderly people with uncontrolled hypertension, when compared to in-person pharmaceutical care?
- How effective is a pharmaceutical care protocol via teleconsultation in adherence to the treatment of elderly people with hypertension, when compared to in-person pharmaceutical care?
Read more
Participants will undergo four visits. Two visits will be for the application of instruments and measurement of clinical parameters to be carried out at the beginning and end of follow-up (visits 1 and 4). These will be carried out in a pharmacist's office at the pharmacy by previously trained pharmacists and pharmacy students. Visits 2 and 3 will be pharmaceutical consultations to be carried out in person and/or via telepharmacy.
Researchers will compare pharmaceutical care via telepharmacy with in-person pharmaceutical care to see how effective these services are in controlling blood pressure in elderly patients with uncontrolled blood pressure.
Read the detailed description
Specific objectives
- Characterize the clinical and socio-demographic profile of the studied population.
- Compare the acceptance and clinical importance of interventions carried out by the pharmacist between the telepharmacy and in-person (control) groups.
- Evaluate patient adherence to medication treatment in the teleconsultation group and in person
- Evaluate patient satisfaction in the teleconsultation group and in-person consultation.
- Compare satisfaction between the telepharmacy and in-person (control) groups.
- Conditions
- Hypertension
- Being tested
- Pharmaceutical care via telepharmacy and usual care, Pharmaceutical care in-person and usual care
- Keywords
- pharmaceutical care, telepharmacy, elderly patients
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical care via telepharmacy and usual careOther
Pharmacotherapeutic monitoring via telephone consultation
Pharmaceutical care in-person and usual careOther
Face-to-face pharmacotherapeutic monitoring
| Study group | Role | What they receive |
|---|---|---|
| Telepharmacy | Experimental | Pharmaceutical care via telepharmacy Receives: Other: Pharmaceutical care via telepharmacy and usual care |
| In-person | Active comparator | In-person pharmaceutical care Receives: Other: Pharmaceutical care in-person and usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Controlling blood pressure
Rate of patients reaching the blood pressure target for healthy elderly people: systolic pressure of 130-139 mmHg and diastolic pressure of 70-79 mmHg; and for frail elderly people: systolic pressure of 140-149 mmHg and diastolic pressure of 70-79mmHg according to guidelines from the Brazilian Society of Cardiology of 2020
Measured: 3 months
Secondary outcomes (3)
Adherence to the treatment
Patients who score higher than eight points on the adherence scale will be considered to have high adherence, those who score between six and seven points will be classified as medium adherence and those who score less than 6 points will be classified as low adherence.
Measured: 3 months
Patient satisfaction
The score will be calculated by the sum of the user's answers divided by the number of corresponding questions. Thus, the closer to 5, the greater the satisfaction with the service and the closer to 1, the greater the dissatisfaction.
Measured: 3 months
Level of clinical significance of interventions
Clinical significance of the intervention as described by the DOCUMENT, which classifies interventions into four levels of clinical significance: low; light; moderate and high.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Nov 2023
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Márcio Galvão Guimarães de Oliveira, Federal University of Bahia
- Investigators
- Gabriella F Magalhães, Study chair, UFOBMárcio Galvão Guimarães de Oliveira, Principal investigator, UFBAIgor Matheus de novais Silva, Study chair, UFBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108674
- Sponsor's protocol ID
- CELESTE2023
- Acronym
- CELESTE
- Status last verified
- Aug 2025
- First submitted
- 25 Oct 2023
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Afreen N, Padilla-Tolentino E, McGinnis B. Identifying Potential High-Risk Medication Errors Using Telepharmacy and a Web-Based Survey Tool. Innov Pharm. 2021 Feb 12;12(1):10.24926/iip.v12i1.3377. doi: 10.24926/iip.v12i1.3377. eCollection 2021.
PubMed 34007681Alexander E, Butler CD, Darr A, Jenkins MT, Long RD, Shipman CJ, Stratton TP. ASHP Statement on Telepharmacy. Am J Health Syst Pharm. 2017 May 1;74(9):e236-e241. doi: 10.2146/ajhp170039. No abstract available.
PubMed 28438829Amkreutz J, Lenssen R, Marx G, Deisz R, Eisert A. Medication safety in a German telemedicine centre: Implementation of a telepharmaceutical expert consultation in addition to existing tele-intensive care unit services. J Telemed Telecare. 2020 Jan-Feb;26(1-2):105-112. doi: 10.1177/1357633X18799796. Epub 2018 Sep 25.
PubMed 30253681Ekeland AG, Bowes A, Flottorp S. Effectiveness of telemedicine: a systematic review of reviews. Int J Med Inform. 2010 Nov;79(11):736-71. doi: 10.1016/j.ijmedinf.2010.08.006.
PubMed 20884286Freeman R, Wieling W, Axelrod FB, Benditt DG, Benarroch E, Biaggioni I, Cheshire WP, Chelimsky T, Cortelli P, Gibbons CH, Goldstein DS, Hainsworth R, Hilz MJ, Jacob G, Kaufmann H, Jordan J, Lipsitz LA, Levine BD, Low PA, Mathias C, Raj SR, Robertson D, Sandroni P, Schatz I, Schondorff R, Stewart JM, van Dijk JG. Consensus statement on the definition of orthostatic hypotension, neurally mediated syncope and the postural tachycardia syndrome. Clin Auton Res. 2011 Apr;21(2):69-72. doi: 10.1007/s10286-011-0119-5. No abstract available.
PubMed 21431947Gandapur Y, Kianoush S, Kelli HM, Misra S, Urrea B, Blaha MJ, Graham G, Marvel FA, Martin SS. The role of mHealth for improving medication adherence in patients with cardiovascular disease: a systematic review. Eur Heart J Qual Care Clin Outcomes. 2016 Oct 1;2(4):237-244. doi: 10.1093/ehjqcco/qcw018.
PubMed 29474713Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D, Tyll L, Larson EB, Thompson RS. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008 Jun 25;299(24):2857-67. doi: 10.1001/jama.299.24.2857.
PubMed 18577730Al Hamid A, Ghaleb M, Aljadhey H, Aslanpour Z. A systematic review of qualitative research on the contributory factors leading to medicine-related problems from the perspectives of adult patients with cardiovascular diseases and diabetes mellitus. BMJ Open. 2014 Sep 19;4(9):e005992. doi: 10.1136/bmjopen-2014-005992.
PubMed 25239295Diedrich L, Dockweiler C. Video-based teleconsultations in pharmaceutical care - A systematic review. Res Social Adm Pharm. 2021 Sep;17(9):1523-1531. doi: 10.1016/j.sapharm.2020.12.002. Epub 2020 Dec 13.
PubMed 33341405Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Groen SE, Kadrmas HM, Kerby TJ, Klotzle KJ, Maciosek MV, Michels RD, O'Connor PJ, Pritchard RA, Sekenski JL, Sperl-Hillen JM, Trower NK. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial. JAMA. 2013 Jul 3;310(1):46-56. doi: 10.1001/jama.2013.6549.
PubMed 23821088Williams M, Peterson GM, Tenni PC, Bindoff IK, Stafford AC. DOCUMENT: a system for classifying drug-related problems in community pharmacy. Int J Clin Pharm. 2012 Feb;34(1):43-52. doi: 10.1007/s11096-011-9583-1. Epub 2011 Nov 19.
PubMed 22101425
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Telepharmacy on Clinical Outcomes of Patients With Arterial Hypertension: Celeste Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06108674
- Acronym / sponsor ID
- CELESTE / CELESTE2023
- Conditions
- Hypertension
- Keywords
- pharmaceutical care, telepharmacy, elderly patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 31 Oct 2023 (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 goal of this clinical trial is to compare the effectiveness of a pharmaceutical care protocol via teleconsultation in the management of uncontrolled hypertension with pharmaceutical care carried out in elderly patients assisted in primary health care. The main questions it aims to answer are:
- How effective is a pharmaceutical care protocol via teleconsultation on the clinical outcomes of elderly people with uncontrolled hypertension, when compared to in-person pharmaceutical care?
- How effective is a pharmaceutical care protocol via teleconsultation in adherence to the treatment of elderly people with hypertension, when compared to in-person pharmaceutical care?
Participants will undergo four visits. Two visits will be for the application of instruments and measurement of clinical parameters to be carried out at the beginning and end of follow-up (visits 1 and 4). These will be carried out in a pharmacist's office at the pharmacy by previously trained pharmacists and pharmacy students. Visits 2 and 3 will be pharmaceutical consultations to be carried out in person and/or via telepharmacy.
Researchers will compare pharmaceutical care via telepharmacy with in-person pharmaceutical care to see how effective these services are in controlling blood pressure in elderly patients with uncontrolled blood pressure.
Detailed description
Specific objectives
- Characterize the clinical and socio-demographic profile of the studied population.
- Compare the acceptance and clinical importance of interventions carried out by the pharmacist between the telepharmacy and in-person (control) groups.
- Evaluate patient adherence to medication treatment in the teleconsultation group and in person
- Evaluate patient satisfaction in the teleconsultation group and in-person consultation.
- Compare satisfaction between the telepharmacy and in-person (control) groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telepharmacy | Experimental | Other: Pharmaceutical care via telepharmacy and usual carePharmaceutical care via telepharmacy |
| In-person | Active comparator | Other: Pharmaceutical care in-person and usual careIn-person pharmaceutical care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elderly patients admitted to the service with a diagnosis of systemic arterial hypertension made by a physician based on a patient report, report or medical prescription.
- Patients who present uncontrolled blood pressure at the time of assessment based on the average of three measurements using a standardized protocol at the pharmacy will be included;
- Patients must have a cell phone and know how to use it;
- Patient not have previously received pharmaceutical care.
Key exclusion criteria (3 listed)
- Elderly people who are unable to use their cell phones due to cognitive impairments (Mini Mental State Examination (MMSE).
- Elderly person considered unable of using a telephone (Instrumental Activities of Daily Living)
- Elderly with controlled blood pressure according to home monitoring.
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 care via telepharmacy and usual carePharmacotherapeutic monitoring via telephone consultation | Other | Telepharmacy |
| Pharmaceutical care in-person and usual careFace-to-face pharmacotherapeutic monitoring | Other | In-person |
Primary outcome
Controlling blood pressure
Time frame: 3 months
Rate of patients reaching the blood pressure target for healthy elderly people: systolic pressure of 130-139 mmHg and diastolic pressure of 70-79 mmHg; and for frail elderly people: systolic pressure of 140-149 mmHg and diastolic pressure of 70-79mmHg according to guidelines from the Brazilian Society of Cardiology of 2020
3 secondary outcomes
Adherence to the treatment
Time frame: 3 months
Patient satisfaction
Time frame: 3 months
Level of clinical significance of interventions
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Background: PubMed 34007681Afreen N, Padilla-Tolentino E, McGinnis B. Identifying Potential High-Risk Medication Errors Using Telepharmacy and a Web-Based Survey Tool. Innov Pharm. 2021 Feb 12;12(1):10.24926/iip.v12i1.3377. doi: 10.24926/iip.v12i1.3377. eCollection 2021.
- Background: PubMed 28438829Alexander E, Butler CD, Darr A, Jenkins MT, Long RD, Shipman CJ, Stratton TP. ASHP Statement on Telepharmacy. Am J Health Syst Pharm. 2017 May 1;74(9):e236-e241. doi: 10.2146/ajhp170039. No abstract available.
- Background: PubMed 30253681Amkreutz J, Lenssen R, Marx G, Deisz R, Eisert A. Medication safety in a German telemedicine centre: Implementation of a telepharmaceutical expert consultation in addition to existing tele-intensive care unit services. J Telemed Telecare. 2020 Jan-Feb;26(1-2):105-112. doi: 10.1177/1357633X18799796. Epub 2018 Sep 25.
- Background: PubMed 20884286Ekeland AG, Bowes A, Flottorp S. Effectiveness of telemedicine: a systematic review of reviews. Int J Med Inform. 2010 Nov;79(11):736-71. doi: 10.1016/j.ijmedinf.2010.08.006.
- Background: PubMed 21431947Freeman R, Wieling W, Axelrod FB, Benditt DG, Benarroch E, Biaggioni I, Cheshire WP, Chelimsky T, Cortelli P, Gibbons CH, Goldstein DS, Hainsworth R, Hilz MJ, Jacob G, Kaufmann H, Jordan J, Lipsitz LA, Levine BD, Low PA, Mathias C, Raj SR, Robertson D, Sandroni P, Schatz I, Schondorff R, Stewart JM, van Dijk JG. Consensus statement on the definition of orthostatic hypotension, neurally mediated syncope and the postural tachycardia syndrome. Clin Auton Res. 2011 Apr;21(2):69-72. doi: 10.1007/s10286-011-0119-5. No abstract available.
- Background: PubMed 29474713Gandapur Y, Kianoush S, Kelli HM, Misra S, Urrea B, Blaha MJ, Graham G, Marvel FA, Martin SS. The role of mHealth for improving medication adherence in patients with cardiovascular disease: a systematic review. Eur Heart J Qual Care Clin Outcomes. 2016 Oct 1;2(4):237-244. doi: 10.1093/ehjqcco/qcw018.
- Background: PubMed 18577730Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D, Tyll L, Larson EB, Thompson RS. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008 Jun 25;299(24):2857-67. doi: 10.1001/jama.299.24.2857.
- Background: PubMed 25239295Al Hamid A, Ghaleb M, Aljadhey H, Aslanpour Z. A systematic review of qualitative research on the contributory factors leading to medicine-related problems from the perspectives of adult patients with cardiovascular diseases and diabetes mellitus. BMJ Open. 2014 Sep 19;4(9):e005992. doi: 10.1136/bmjopen-2014-005992.
- Background: PubMed 33341405Diedrich L, Dockweiler C. Video-based teleconsultations in pharmaceutical care - A systematic review. Res Social Adm Pharm. 2021 Sep;17(9):1523-1531. doi: 10.1016/j.sapharm.2020.12.002. Epub 2020 Dec 13.
- Background: PubMed 23821088Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Groen SE, Kadrmas HM, Kerby TJ, Klotzle KJ, Maciosek MV, Michels RD, O'Connor PJ, Pritchard RA, Sekenski JL, Sperl-Hillen JM, Trower NK. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial. JAMA. 2013 Jul 3;310(1):46-56. doi: 10.1001/jama.2013.6549.
- Background: PubMed 22101425Williams M, Peterson GM, Tenni PC, Bindoff IK, Stafford AC. DOCUMENT: a system for classifying drug-related problems in community pharmacy. Int J Clin Pharm. 2012 Feb;34(1):43-52. doi: 10.1007/s11096-011-9583-1. Epub 2011 Nov 19.
- Diretrizes Brasileiras de Hipertensão Arterial - 2020. Arq Bras Cardiol.Link provided by the sponsor.
- PORTARIA GM/MS Nº 1.348, DE 2 DE JUNHO DE 2022Link provided by the sponsor.
- BRASIL, Ministério da Saúde. O que é Prontuário Eletrônico do Cidadão?Link provided by the sponsor.
- Vigitel Brasil 2014: vigilância de fatores de risco e proteção para doenças crônicas por inquérito telefônico.Link provided by the sponsor.
- Telepharmacy shows it worth in Cancer Setting.Link provided by the sponsor.
- Patient satisfaction with pharmacy services: translation and validation of the Pharmacy Services Questionnaire for BrazilLink provided by the sponsor.
- 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.
Gabriella F Magalhães study chair
UFOB
Márcio Galvão Guimarães de Oliveira principal investigator
UFBA
Igor Matheus de novais Silva study chair
UFBA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hypertension, run by Federal University of Bahia 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriella F Magalhães (77999062525, gabimagalhaes@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Controlling blood pressure (time frame: 3 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 NCT06108674, which also lists 11 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 12 Aug 2025.