Stroke, IschemicEarly Phase 1NCT03211130
Using SystemCHANGE™ to Enhance Medication Adherence in Older Adult Stroke Survivors
A Early Phase 1 study testing SystemCHANGE™ in people with Stroke, Ischemic, run by University of Missouri, Kansas City at 1 site in United States.
Trial summary
This study evaluated the feasibility and acceptability of using a SystemCHANGE intervention in older adult stroke survivors to improve medication adherence. Half the participants will receive the SystemCHANGE intervention, while the other half will receive the attention-control education intervention. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- SystemCHANGE™
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2017to 24 May 2018
- Phase
- Early Phase 1
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥50 years old
- receives post-stroke care with Saint Luke's Neurological Consultants
- prescribed at least 1, once a day, antithrombotic medication
- able to provide informed consent
- able to open an electronic cap
- able to self-administer medications
- has or has access to a telephone
- has no cognitive impairment as determined by a score of 4 or greater on The Six- item Screener (SIS).
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Pilot Study of a SystemCHANGE™ Medication Adherence Intervention in Older Adult Stroke Survivors
This study evaluated the feasibility and acceptability of using a SystemCHANGE intervention in older adult stroke survivors to improve medication adherence. Half the participants will receive the SystemCHANGE intervention, while the other half will receive the attention-control education intervention.
- Conditions
- Stroke, Ischemic
- Being tested
- SystemCHANGE™, Attention-Control
- Keywords
- medication adherence, self-management, antithrombotic
- Medical subject headings
- Ischemic Stroke, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SystemCHANGE™Behavioural
During the intervention phase, the PI will visit both groups of participants at home at baseline and telephone them three times (day 3 ±2 days and months 1 and 2). Refer to tables 1 and 2 for intervention details. Treatment participants will implement SystemCHANGE™ activities related to medication taking with the assistance of the PI while attention-control participants will receive patient education materials on stroke. Perceived health data will be collected during the intervention phase. A 1-month maintenance phase follows the intervention phase. Electronic medication monitoring continues, but no intervention is delivered to either group.
Attention-ControlBehavioural
An experienced stroke nurse will deliver the attention control intervention. Table 3.2 shows the 2-month attention-control intervention. The stroke materials were developed by the Saint Luke's Marion Bloch Neuroscience Institute and are given to every stroke patient prior to dismissal. The PI will call participants at day 3 ±2 days, and months 1 and 2 to review chapter(s) from the book and answer questions about it. Interval, frequency, and setting are all exactly the same for the intervention and control groups. If the control participant raises questions about medications or medication-taking, PI will refer them to their Neurologist.
| Study group | Role | What they receive |
|---|---|---|
| SystemCHANGE™ | Experimental | Not described Receives: Behavioral: SystemCHANGE™ |
| Attention-Control | Active comparator | Not described Receives: Behavioral: Attention-Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and feasibility
Open ended questionnaire
Measured: one point in time at the end of the maintenance phase which is 3 months after randomization into groups
Secondary outcomes (4)
Social Support
The Social Support Appraisals Index (SS-A) is a 23-item self-administered, a self-report scale measuring the degree to which a person feels cared for, respected, and involved with family and friends. The scale had good reliability and validity (Cronbach α coefficients .90, .81, and .84) (Vaux et al., 1986).
Measured: One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
Perceived Health
Perceived health status will be measured by one question, "How is your health in general?" Participant select excellent, very good, good, fair, poor, or very poor. Perceived health status reflects people's overall perception of their health, including both physical and psychological dimensions.
Measured: One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
Personal Systems Behaviors
The Systems Thinking Survey (adapted for patients), a 20-item, 5-point Likert response scale measuring perceptions of personal system behaviors.
Measured: One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
Medication Adherence
MA data will be retrieved from the MEMS®cap which is a medication cap containing a battery and microelectronics that records the date and the time of each cap removal to create a medication "event" ("MEMS® Cap versatile adherence monitoring cap," n.d.).
Measured: after randomization through end of maintenance phase for a total of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start28 Nov 2017
- Primary completion6 Feb 2018
- Study completion24 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Luke's Health System
- Responsible party
- Principal investigator, Cynthia Russell, University of Missouri, Kansas City
- Investigators
- Jennifer L. Wessol, BSN, Principal investigator, University of Missouri, Kansas CityCynthia L. Russell, Ph.D., Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211130
- Sponsor's protocol ID
- Dissertation
- Status last verified
- Aug 2019
- First submitted
- 5 Jul 2017
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Study of a SystemCHANGE™ Medication Adherence Intervention in Older Adult Stroke Survivors
- ClinicalTrials.gov ID
- NCT03211130
- Acronym / sponsor ID
- Dissertation
- Conditions
- Stroke, Ischemic
- Keywords
- medication adherence, self-management, antithrombotic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Collaborators
- Saint Luke's Health System
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 7 Jul 2017 (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.
This study evaluated the feasibility and acceptability of using a SystemCHANGE intervention in older adult stroke survivors to improve medication adherence. Half the participants will receive the SystemCHANGE intervention, while the other half will receive the attention-control education intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SystemCHANGE™ | Experimental | Behavioral: SystemCHANGE™ |
| Attention-Control | Active comparator | Behavioral: Attention-Control |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age ≥50 years old
- receives post-stroke care with Saint Luke's Neurological Consultants
- prescribed at least 1, once a day, antithrombotic medication
- able to provide informed consent
- able to open an electronic cap
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| SystemCHANGE™During the intervention phase, the PI will visit both groups of participants at home at baseline and telephone them three times (day 3 ±2 days and months 1 and 2). Refer to tables 1 and 2 for intervention details. Treatment participants will implement SystemCHANGE™ activities related to medication taking with the assistance of the PI while attention-control participants will receive patient education materials on stroke. Perceived health data will be collected during the intervention phase. A 1-month maintenance phase follows the intervention phase. Electronic medication monitoring continues, but no intervention is delivered to either group. | Behavioural | SystemCHANGE™ |
| Attention-ControlAn experienced stroke nurse will deliver the attention control intervention. Table 3.2 shows the 2-month attention-control intervention. The stroke materials were developed by the Saint Luke's Marion Bloch Neuroscience Institute and are given to every stroke patient prior to dismissal. The PI will call participants at day 3 ±2 days, and months 1 and 2 to review chapter(s) from the book and answer questions about it. Interval, frequency, and setting are all exactly the same for the intervention and control groups. If the control participant raises questions about medications or medication-taking, PI will refer them to their Neurologist. | Behavioural | Attention-Control |
Primary outcome
Acceptability and feasibility
Time frame: one point in time at the end of the maintenance phase which is 3 months after randomization into groups
Open ended questionnaire
4 secondary outcomes
Social Support
Time frame: One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
Perceived Health
Time frame: One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
Personal Systems Behaviors
Time frame: One day at beginning of Intervention phase. Once 1 day at beginning of Maintenance phase.
Medication Adherence
Time frame: after randomization through end of maintenance phase for a total of 3 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 21 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
Jennifer L. Wessol, BSN principal investigator
University of Missouri, Kansas City
Cynthia L. Russell, Ph.D. study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SystemCHANGE™ in people with Stroke, Ischemic, run by University of Missouri, Kansas City 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 8 inclusion and 1 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 21 Aug 2019. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Acceptability and feasibility (time frame: one point in time at the end of the maintenance phase which is 3 months after randomization into groups). 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 21 Aug 2019.