StrokeNCT04877171

Telemedicine Efficacy in Medication Adherence in Post-ischemic Stroke Patients

A study testing telemedicine neurology consultation and in-person neurology consultation in people with Stroke and Compliance, Patient, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Telemedicine is an incipient resource to support the stroke system of care in Colombia. Several studies had demonstrated that patients benefit by implementing telestroke, for instance, providing timely and appropriate neurological consultation, diminishing accessible barriers, improving medication adherence for… Read more about this study

Who is it for?: Ages 18 to 86 years
Conditions the study is for: Stroke, Compliance, Patient, Compliance, Treatment
What is being tested?: telemedicine neurology consultation and in-person neurology consultation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteColombia
Study dates: 16 Jul 2021to 30 Aug 2022
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 to 86 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

First ischemic stroke.
Lived in urban areas.
Available Access to permanent internet at home, in work on mobile dispositive, computers or tablets.
Patients who gave their written informed consent.

Who cannot join

Diagnosis of neurodegenerative diseases such as dementia and Parkinson's disease.
Diagnosis of Diseases-terminal to prevent tracking.
Diagnosis of psychiatric illnesses such as major depressive disorder (MDD) or others.
Global cognitive impairment or previous diagnosis of dementia.

Trial locations and contacts

1 site in 1 country.

Federico A Silva, MD, MSc, MBA contact

3174358166

federicosilva@fcv.org

Colombia1 site, 1 recruiting

Hospital Internacional de Colombia
Piedecuesta, Santander Department
Federico A Silva, MD, MSc, MBA
Jenny P Garzon, MD
Recruiting

Other trials in Colombia

About this study

Hypothesis: The use of Telemedicine improves medication adherence in Post-ischemic Stroke.

Study Design: This is a randomized, single-blind, clinical trial to assess the efficacy of Telemedicine, over medication adherence in Post-ischemic Stroke subjects from Colombia.

Population: Eighty-four Post-ischemic Stroke subjects, subjects of both genders, over 18 years old, with a first stroke will be included.

Ethical Aspects: The study will be conducted according to the Helsinki declaration, the good clinical practices guidelines and the Colombian legislation. Prior to entering the study, patients must sign a written or oral informed consent that has been approved by the Institutional Ethics Committee of Fundación Cardiovascular de Colombia.

Overall objective: this study aims to determine the efficacy of telemedicine on pharmacological adherence in post-ischemic Stroke Participants.

Focus of study: Adherence to secondary stroke prevention medication.

Conditions: Stroke, Compliance, Patient, Compliance, Treatment, Compliance, Medication
Being tested: telemedicine neurology consultation, in-person neurology consultation
Keywords: Stroke consultation, Telemedicine, Recovery, Rehabilitation
Medical subject headings: Stroke, Patient Compliance, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

telemedicine neurology consultationOther
consultations via phone-only at 12-14-day post-discharge. Consultations via phone both audio and video at 1, 3 and 6 months
in-person neurology consultationOther
consultation in-person at Hospital Internacional de Colombia

Study groups in NCT04877171
Study group	Role	What they receive
telemedicine neurology consultation	Experimental	Starting on day 12-14 post-discharge, participants will receive a phone call for a drug conciliation. Participants at 1-month post-discharge will receive a telemedicine consultation, another at 3 months and 6 months. Receives: Other: telemedicine neurology consultation
in-person neurology consultation	Active comparator	Starting at 1-month post-discharge, participants will attend an in-person neurology consultation and the following consultations depend on their physician's criteria until completed 6 months post-discharge. Receives: Other: in-person neurology consultation

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage medication adherence through Morisky-Green questionnaire
The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behavior. It consists of 4 items, with binary scoring (yes/no). Patients score one point for every 'Yes' answer. A score of 0 indicates high adherence; a score of 1 or 2 indicates intermediate adherence, and a score of 3 or 4 indicates low adherence.
Measured: 6 months

Secondary outcomes (2)

The Fantastic lifestyle assessment questionnaire
The fantastic instrument consists of a questionnaire with 25 closed-end questions across nine domains of the physical, psychological, and social components of lifestyle. The 23 first questions have multiple-choice (five answers) and the last two are dichotomous. The sum of all points yields a total score that classifies individuals in five categories, as follows: "Excellent" (85 to 100 points), "Very good" (70 to 84 points), "Good" (55 to 69 points), "Regular" (35 to 54 points), and "Needing improvement" (0 to 34 points).
Measured: 6 months
Caregiver burden questionnaire
The Zarit Burden instrument contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always) with the sum of scores ranging between 0-88. Higher scores are taken to indicate increased burden intensity (score: ≤21=no burden; 21-40 = mild burden; 41-60 = moderate burden; ≥61 = severe burden).
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jul 202130 Aug 2022

First posted7 May 2021
Study start16 Jul 2021
Primary completion31 Jul 2022 (estimated)
Study completion30 Aug 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for StrokeStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 84 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04877171
Sponsor's protocol ID: CEI-2020-01644
Status last verified: Aug 2021
First submitted: 26 Apr 2021
Last updated: 1 Sep 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Broderick JP, Abir M. Transitions of Care for Stroke Patients: Opportunities to Improve Outcomes. Circ Cardiovasc Qual Outcomes. 2015 Oct;8(6 Suppl 3):S190-2. doi: 10.1161/CIRCOUTCOMES.115.002288. No abstract available.
PubMed 26515208
Kalanithi L, Tai W, Conley J, Platchek T, Zulman D, Milstein A. Better health, less spending: delivery innovation for ischemic cerebrovascular disease. Stroke. 2014 Oct;45(10):3105-11. doi: 10.1161/STROKEAHA.114.006236. Epub 2014 Aug 14. No abstract available.
PubMed 25123221
Coleman EA, Parry C, Chalmers S, Min SJ. The care transitions intervention: results of a randomized controlled trial. Arch Intern Med. 2006 Sep 25;166(17):1822-8. doi: 10.1001/archinte.166.17.1822.
PubMed 17000937
Naylor M, Brooten D, Jones R, Lavizzo-Mourey R, Mezey M, Pauly M. Comprehensive discharge planning for the hospitalized elderly. A randomized clinical trial. Ann Intern Med. 1994 Jun 15;120(12):999-1006. doi: 10.7326/0003-4819-120-12-199406150-00005.
PubMed 8185149
Poston KM, Dumas BP, Edlund BJ. Outcomes of a quality improvement project implementing stroke discharge advocacy to reduce 30-day readmission rates. J Nurs Care Qual. 2014 Jul-Sep;29(3):237-44. doi: 10.1097/NCQ.0000000000000040.
PubMed 24322371
Ogren J, Irewall AL, Soderstrom L, Mooe T. Long-term, telephone-based follow-up after stroke and TIA improves risk factors: 36-month results from the randomized controlled NAILED stroke risk factor trial. BMC Neurol. 2018 Sep 21;18(1):153. doi: 10.1186/s12883-018-1158-5.
PubMed 30241499
Cameron JI, O'Connell C, Foley N, Salter K, Booth R, Boyle R, Cheung D, Cooper N, Corriveau H, Dowlatshahi D, Dulude A, Flaherty P, Glasser E, Gubitz G, Hebert D, Holzmann J, Hurteau P, Lamy E, LeClaire S, McMillan T, Murray J, Scarfone D, Smith EE, Shum V, Taylor K, Taylor T, Yanchula C, Teasell R, Lindsay P; Heart and Stroke Foundation Canadian Stroke Best Practice Committees. Canadian Stroke Best Practice Recommendations: Managing transitions of care following Stroke, Guidelines Update 2016. Int J Stroke. 2016 Oct;11(7):807-22. doi: 10.1177/1747493016660102. Epub 2016 Jul 21.
PubMed 27443991
Duncan PW, Bushnell CD, Rosamond WD, Jones Berkeley SB, Gesell SB, D'Agostino RB Jr, Ambrosius WT, Barton-Percival B, Bettger JP, Coleman SW, Cummings DM, Freburger JK, Halladay J, Johnson AM, Kucharska-Newton AM, Lundy-Lamm G, Lutz BJ, Mettam LH, Pastva AM, Sissine ME, Vetter B. The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trial. BMC Neurol. 2017 Jul 17;17(1):133. doi: 10.1186/s12883-017-0907-1.
PubMed 28716014
Ross L, Bena J, Bermel R, McCarter L, Ahmed Z, Goforth H, Cherian N, Kriegler J, Estemalik E, Stanton M, Rasmussen P, Fernandez HH, Najm I, McGinley M. Implementation and Patient Experience of Outpatient Teleneurology. Telemed J E Health. 2021 Mar;27(3):323-329. doi: 10.1089/tmj.2020.0032. Epub 2020 Jun 23.
PubMed 32584654
Appireddy R, Khan S, Leaver C, Martin C, Jin A, Durafourt BA, Archer SL. Home Virtual Visits for Outpatient Follow-Up Stroke Care: Cross-Sectional Study. J Med Internet Res. 2019 Oct 7;21(10):e13734. doi: 10.2196/13734.
PubMed 31593536
Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
PubMed 3945130
Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
PubMed 7203086

Want to know more?

Federico A Silva, MD, MSc, MBA

3174358166

federicosilva@fcv.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telemedicine Efficacy in Medication Adherence in Post-ischemic Stroke Patients
ClinicalTrials.gov ID: NCT04877171
Acronym / sponsor ID: CEI-2020-01644
Conditions: Stroke, Compliance, Patient, Compliance, Treatment, Compliance, Medication
Keywords: Stroke consultation, Telemedicine, Recovery, Rehabilitation
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 84 participants (estimated)
Lead sponsor: Fundación Cardiovascular de ColombiaUniversity, hospital or other
Collaborators: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Study start: 16 Jul 2021 (actual)
Primary completion: 31 Jul 2022 (estimated)
Study completion: 30 Aug 2022 (estimated)
First posted: 7 May 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.

Hypothesis: The use of Telemedicine improves medication adherence in Post-ischemic Stroke.

Study Design: This is a randomized, single-blind, clinical trial to assess the efficacy of Telemedicine, over medication adherence in Post-ischemic Stroke subjects from Colombia.

Population: Eighty-four Post-ischemic Stroke subjects, subjects of both genders, over 18 years old, with a first stroke will be included.

Overall objective: this study aims to determine the efficacy of telemedicine on pharmacological adherence in post-ischemic Stroke Participants.

Focus of study: Adherence to secondary stroke prevention medication.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
telemedicine neurology consultation	Experimental	Other: telemedicine neurology consultationStarting on day 12-14 post-discharge, participants will receive a phone call for a drug conciliation. Participants at 1-month post-discharge will receive a telemedicine consultation, another at 3 months and 6 months.
in-person neurology consultation	Active comparator	Other: in-person neurology consultationStarting at 1-month post-discharge, participants will attend an in-person neurology consultation and the following consultations depend on their physician's criteria until completed 6 months post-discharge.

Who may qualify

Ages: 18 to 86 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

First ischemic stroke.
Lived in urban areas.
Available Access to permanent internet at home, in work on mobile dispositive, computers or tablets.
Patients who gave their written informed consent.

Key exclusion criteria (4 listed)

Diagnosis of neurodegenerative diseases such as dementia and Parkinson's disease.
Diagnosis of Diseases-terminal to prevent tracking.
Diagnosis of psychiatric illnesses such as major depressive disorder (MDD) or others.
Global cognitive impairment or previous diagnosis of dementia.

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
telemedicine neurology consultationconsultations via phone-only at 12-14-day post-discharge. Consultations via phone both audio and video at 1, 3 and 6 months	Other	telemedicine neurology consultation
in-person neurology consultationconsultation in-person at Hospital Internacional de Colombia	Other	in-person neurology consultation

Primary outcome

Percentage medication adherence through Morisky-Green questionnaire
Time frame: 6 months
The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behavior. It consists of 4 items, with binary scoring (yes/no). Patients score one point for every 'Yes' answer. A score of 0 indicates high adherence; a score of 1 or 2 indicates intermediate adherence, and a score of 3 or 4 indicates low adherence.

2 secondary outcomes

The Fantastic lifestyle assessment questionnaire
Time frame: 6 months
Caregiver burden questionnaire
Time frame: 6 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
Background: PubMed 26515208Broderick JP, Abir M. Transitions of Care for Stroke Patients: Opportunities to Improve Outcomes. Circ Cardiovasc Qual Outcomes. 2015 Oct;8(6 Suppl 3):S190-2. doi: 10.1161/CIRCOUTCOMES.115.002288. No abstract available.
Background: PubMed 25123221Kalanithi L, Tai W, Conley J, Platchek T, Zulman D, Milstein A. Better health, less spending: delivery innovation for ischemic cerebrovascular disease. Stroke. 2014 Oct;45(10):3105-11. doi: 10.1161/STROKEAHA.114.006236. Epub 2014 Aug 14. No abstract available.
Background: PubMed 17000937Coleman EA, Parry C, Chalmers S, Min SJ. The care transitions intervention: results of a randomized controlled trial. Arch Intern Med. 2006 Sep 25;166(17):1822-8. doi: 10.1001/archinte.166.17.1822.
Background: PubMed 8185149Naylor M, Brooten D, Jones R, Lavizzo-Mourey R, Mezey M, Pauly M. Comprehensive discharge planning for the hospitalized elderly. A randomized clinical trial. Ann Intern Med. 1994 Jun 15;120(12):999-1006. doi: 10.7326/0003-4819-120-12-199406150-00005.
Background: PubMed 24322371Poston KM, Dumas BP, Edlund BJ. Outcomes of a quality improvement project implementing stroke discharge advocacy to reduce 30-day readmission rates. J Nurs Care Qual. 2014 Jul-Sep;29(3):237-44. doi: 10.1097/NCQ.0000000000000040.
Background: PubMed 30241499Ogren J, Irewall AL, Soderstrom L, Mooe T. Long-term, telephone-based follow-up after stroke and TIA improves risk factors: 36-month results from the randomized controlled NAILED stroke risk factor trial. BMC Neurol. 2018 Sep 21;18(1):153. doi: 10.1186/s12883-018-1158-5.
Background: PubMed 27443991Cameron JI, O'Connell C, Foley N, Salter K, Booth R, Boyle R, Cheung D, Cooper N, Corriveau H, Dowlatshahi D, Dulude A, Flaherty P, Glasser E, Gubitz G, Hebert D, Holzmann J, Hurteau P, Lamy E, LeClaire S, McMillan T, Murray J, Scarfone D, Smith EE, Shum V, Taylor K, Taylor T, Yanchula C, Teasell R, Lindsay P; Heart and Stroke Foundation Canadian Stroke Best Practice Committees. Canadian Stroke Best Practice Recommendations: Managing transitions of care following Stroke, Guidelines Update 2016. Int J Stroke. 2016 Oct;11(7):807-22. doi: 10.1177/1747493016660102. Epub 2016 Jul 21.
Background: PubMed 28716014Duncan PW, Bushnell CD, Rosamond WD, Jones Berkeley SB, Gesell SB, D'Agostino RB Jr, Ambrosius WT, Barton-Percival B, Bettger JP, Coleman SW, Cummings DM, Freburger JK, Halladay J, Johnson AM, Kucharska-Newton AM, Lundy-Lamm G, Lutz BJ, Mettam LH, Pastva AM, Sissine ME, Vetter B. The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trial. BMC Neurol. 2017 Jul 17;17(1):133. doi: 10.1186/s12883-017-0907-1.
Background: PubMed 32584654Ross L, Bena J, Bermel R, McCarter L, Ahmed Z, Goforth H, Cherian N, Kriegler J, Estemalik E, Stanton M, Rasmussen P, Fernandez HH, Najm I, McGinley M. Implementation and Patient Experience of Outpatient Teleneurology. Telemed J E Health. 2021 Mar;27(3):323-329. doi: 10.1089/tmj.2020.0032. Epub 2020 Jun 23.
Background: PubMed 31593536Appireddy R, Khan S, Leaver C, Martin C, Jin A, Durafourt BA, Archer SL. Home Virtual Visits for Outpatient Follow-Up Stroke Care: Cross-Sectional Study. J Med Internet Res. 2019 Oct 7;21(10):e13734. doi: 10.2196/13734.
Background: PubMed 3945130Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
Background: PubMed 7203086Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
Individual participant dataSharing planned: No

Related trials for Stroke

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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
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Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.

Federico A Silva, MD, MSc, MBA contact

3174358166

federicosilva@fcv.org

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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: status not confirmed, as of the sponsor's last update on 1 Sep 2021. 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 Colombia. 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 Federico A Silva, MD, MSc, MBA (3174358166, federicosilva@fcv.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage medication adherence through Morisky-Green questionnaire (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 NCT04877171, which also lists 12 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 1 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.