StrokeNCT03885674
Improving Medication Self-Administration and Health After Brain Injury
A study testing Video Call Reminder Condition and Automated Text Message Reminder Condition in people with Stroke and Stroke, Acute, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this research study is to assess medication self-administration (MSA) and the impact of three different interventions on improving medication adherence. The findings for this study may help develop evidence-based reminder protocols to reduce medication self-administration errors after brain injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke, Acute, Cognitive Impairment
- What is being tested?
- Video Call Reminder Condition and Automated Text Message Reminder Condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18
- Less than three months post Brain Injury event
- English speaking (learned English at age 10 or younger, and use it daily)
- Currently taking up to eight medications on a daily basis
Who cannot join
- Legally blind
- Unable to give informed consent due to comprehension deficits
- Severe memory or cognitive impairments that would not allow for formal testing, as determined by the investigator
- History of psychiatric hospitalization for attempted overdose of pills
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to assess medication self-administration (MSA) and the impact of three different interventions on improving medication adherence. The findings for this study may help develop evidence-based reminder protocols to reduce medication self-administration errors after brain injury.
Read the detailed description
The investigators are interested in studying how brain injury (TBI, stroke, etc.) survivors manage self-administering their medication once they return home, and are aiming to improve their medication adherence. In this six month long study, patients will be placed into one of three intervention groups 1) standard care received (usual care, no reminder provided), 2) receive a video call at time medication is to be taken, 3) receive an automated text message when medication is to be taken. The investigators aim to identify which intervention is best at helping brain injury survivors adhere to their medication schedule, with the future goal of implementing this type of reminder protocol into standard care.
Hypothesis: The investigators hypothesize that automated reminder text messages will result in MSA improvement comparable to video calls, maintained over the six month period.
Allocation to groups: Patients will be randomized to receive video calls, automated text messages, or no intervention (standard care). The randomization schedule is by computer-generated number list.
- Conditions
- Stroke, Stroke, Acute, Cognitive Impairment, Brain Injuries, Traumatic, Medication Adherence, Medication Compliance
- Being tested
- Video Call Reminder Condition, Automated Text Message Reminder Condition
- Medical subject headings
- Stroke, Cognitive Dysfunction, Brain Injuries, Traumatic, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Call Reminder ConditionOther
Receive daily video call reminders from Kessler Foundation research staff directly at the time of each medication dose and instructed to take the medication while on the video call.
Automated Text Message Reminder ConditionOther
Receive daily automated text messages at the time of each medication dose and will be instructed to take the medication at that time. Each text message reminder will also contain a photo of the medication to be taken. On a weekly basis, study personnel will contact participants in this group to make sure they are receiving the text messages appropriately.
| Study group | Role | What they receive |
|---|---|---|
| Reminder Interventions | Experimental | Receive daily reminders from Kessler Foundation study personnel on when to take their medication. Receives: Other: Video Call Reminder Condition; Other: Automated Text Message Reminder Condition |
| Standard Condition | No intervention | This group will not receive reminders on when to take their medication from Kessler Foundation staff and will receive the usual and standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
As measured by Medication Event Monitoring System (MEMS) trackers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study startJul 2016
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
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 StrokeStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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
- Model description
- Patients will be randomized to one of three intervention groups; video call reminders, automated text messages, or no intervention (standard care).
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. M. Barrett, MD, Kessler Foundation
- Investigators
- AM Barrett, MD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885674
- Sponsor's protocol ID
- E-623-08
- Other IDs
- CBIR161RG041
- Status last verified
- Feb 2021
- First submitted
- 20 Mar 2019
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barrett AM, Galletta EE, Zhang J, Masmela JR, Adler US. Stroke survivors over-estimate their medication self-administration (MSA) ability, predicting memory loss. Brain Inj. 2014;28(10):1328-33. doi: 10.3109/02699052.2014.915984. Epub 2014 Jun 2.
PubMed 24884398
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Self-Administration and Health After Brain Injury
- ClinicalTrials.gov ID
- NCT03885674
- Acronym / sponsor ID
- E-623-08
- Conditions
- Stroke, Stroke, Acute, Cognitive Impairment, Brain Injuries, Traumatic, Medication Adherence, Medication Compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Mar 2019 (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 purpose of this research study is to assess medication self-administration (MSA) and the impact of three different interventions on improving medication adherence. The findings for this study may help develop evidence-based reminder protocols to reduce medication self-administration errors after brain injury.
Detailed description
The investigators are interested in studying how brain injury (TBI, stroke, etc.) survivors manage self-administering their medication once they return home, and are aiming to improve their medication adherence. In this six month long study, patients will be placed into one of three intervention groups 1) standard care received (usual care, no reminder provided), 2) receive a video call at time medication is to be taken, 3) receive an automated text message when medication is to be taken. The investigators aim to identify which intervention is best at helping brain injury survivors adhere to their medication schedule, with the future goal of implementing this type of reminder protocol into standard care.
Hypothesis: The investigators hypothesize that automated reminder text messages will result in MSA improvement comparable to video calls, maintained over the six month period.
Allocation to groups: Patients will be randomized to receive video calls, automated text messages, or no intervention (standard care). The randomization schedule is by computer-generated number list.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to one of three intervention groups; video call reminders, automated text messages, or no intervention (standard care).
| Arm | Type | Receives |
|---|---|---|
| Reminder Interventions | Experimental | Other: Video Call Reminder Condition, Other: Automated Text Message Reminder ConditionReceive daily reminders from Kessler Foundation study personnel on when to take their medication. |
| Standard Condition | No intervention | –This group will not receive reminders on when to take their medication from Kessler Foundation staff and will receive the usual and standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than or equal to 18
- Less than three months post Brain Injury event
- English speaking (learned English at age 10 or younger, and use it daily)
- Currently taking up to eight medications on a daily basis
Key exclusion criteria (4 listed)
- Legally blind
- Unable to give informed consent due to comprehension deficits
- Severe memory or cognitive impairments that would not allow for formal testing, as determined by the investigator
- History of psychiatric hospitalization for attempted overdose of pills
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 |
|---|---|---|
| Video Call Reminder ConditionReceive daily video call reminders from Kessler Foundation research staff directly at the time of each medication dose and instructed to take the medication while on the video call. | Other | Reminder Interventions |
| Automated Text Message Reminder ConditionReceive daily automated text messages at the time of each medication dose and will be instructed to take the medication at that time. Each text message reminder will also contain a photo of the medication to be taken. On a weekly basis, study personnel will contact participants in this group to make sure they are receiving the text messages appropriately. | Other | Reminder Interventions |
Primary outcome
Medication Adherence
Time frame: 6 months
As measured by Medication Event Monitoring System (MEMS) trackers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Background: PubMed 24884398Barrett AM, Galletta EE, Zhang J, Masmela JR, Adler US. Stroke survivors over-estimate their medication self-administration (MSA) ability, predicting memory loss. Brain Inj. 2014;28(10):1328-33. doi: 10.3109/02699052.2014.915984. Epub 2014 Jun 2.
- 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.
AM Barrett, MD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Call Reminder Condition and Automated Text Message Reminder Condition in people with Stroke and Stroke, Acute, run by Kessler Foundation at 1 site in United States.
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 17 Feb 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 United States. 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?
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: 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 NCT03885674, 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 17 Feb 2021.