StrokeNCT01770184
Clinical Effectiveness of Self-Management Education Post-Mild Stroke
A study testing Chronic Disease Self-Management Program (CDSMP) in people with Stroke and Chronic Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Individuals who have a mild stroke have a 44% risk of dying from a second stroke within 10 years which is in large part due to the cyclical relationship of chronic disease, poor health, and mild stroke which has gone largely unnoticed in the United States. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Chronic Disease
- What is being tested?
- Chronic Disease Self-Management Program (CDSMP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2016
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a mild stroke as NIHSS total scores 0-5
- 18-90 years of age
- English speaking
- identified as having at least one other chronic condition besides stroke
Who cannot join
- severe aphasia (NIHSS aphasia score=2)
- moderate to severe cognitive impairment (MOCA < 21)
- history of dementia
- hemorrhagic stroke
- neurological diagnoses other than stroke
- major psychiatric illness (A diagnosis of bipolar disorder, obsessive compulsive disorder, panic disorder, schizophrenia, post-traumatic stress disorder, and borderline personality disorder)
- a score of no-higher than 20 on the PHQ-9 indicating significant depressive symptoms
- terminal illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis, School of Medicine, Program in Occupational Therapy
St Louis, Missouri, 63108
About this study
Individuals who have a mild stroke have a 44% risk of dying from a second stroke within 10 years which is in large part due to the cyclical relationship of chronic disease, poor health, and mild stroke which has gone largely unnoticed in the United States. Self-management intervention has been proven to be an effective intervention to increase healthy behaviors, improve overall health status, decrease healthcare utilization/cost, decrease depressive symptoms, and improve participation in people with a variety of chronic conditions; however, it has never be used with individuals with mild stroke. The critical next step and goal of this study is to evaluate if self-management intervention will improve health outcomes for persons with mild stroke. The overall hypothesis of this study is that self-management intervention will improve outcomes in the mild-stroke population.
- Conditions
- Stroke, Chronic Disease
- Being tested
- Chronic Disease Self-Management Program (CDSMP)
- Keywords
- Self-management, Rehabilitation, Occupational Therapy
- Medical subject headings
- Stroke, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Disease Self-Management Program (CDSMP)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will receive the rehabilitation services and support that is recommended and provided in the current health care structure. The intervention group will also receive the Chronic Disease Self-Management Program (CDSMP). The CDSMP is an education program based on the concept of self-management. Self-management refers to the ability of an individual to manage the day-to-day responsibilities of living with a chronic condition. The CDSMP will be delivered in two and a half hour sessions, once a week, for six weeks, in group format. Receives: Behavioral: Chronic Disease Self-Management Program (CDSMP) |
| Usual Care Group | No intervention | The usual care group for this study will receive the rehabilitation services and support that is recommended and provided in the current health care structure. No additional intervention will be provided to the usual care group within this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adapted Illness Intrusiveness Ratings (AIIR)
Measured: Change from baseline to 6-months post-stroke
Healthcare Utilization Survey (HCUS)
Measured: Change from baseline to 6-months post-stroke
Secondary outcomes (8)
Patient Health Questionnaire (PHQ-9)
Measured: Change from baseline to 6-months post-stroke
Work Ability Index (WAI)
Measured: Change from baseline to 6-months post-stroke
Reintegration to Normal Living Index (RNLI)
Measured: Change from baseline to 6-months post-stroke
World Health Organization Quality of Life (WHOQOL-BREF)
Measured: Change from baseline to 6-months post-stroke
Chronic Disease Self-Efficacy Scale (CDSES)
Measured: Change from baseline to 6-months post-stroke
Multidimensional Assessment of Fatigue (MAF)
Measured: Change from baseline to 6-months post-stroke
Activity Card Sort (ACS)
Measured: Change from baseline to 6-months post-stroke
Stroke Impact Scale (SIS)
Measured: Change from baseline to 6-months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionJan 2016
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 Washington University School of MedicineThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy J Wolf, OTD, MSCI, OTR/L, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770184
- Sponsor's protocol ID
- 1K23HD073190-01
- Status last verified
- Apr 2016
- First submitted
- 11 Jan 2013
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
PubMed 34813082
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Self-Management Education Post-Mild Stroke
- ClinicalTrials.gov ID
- NCT01770184
- Acronym / sponsor ID
- 1K23HD073190-01
- Conditions
- Stroke, Chronic Disease
- Keywords
- Self-management, Rehabilitation, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 17 Jan 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.
Individuals who have a mild stroke have a 44% risk of dying from a second stroke within 10 years which is in large part due to the cyclical relationship of chronic disease, poor health, and mild stroke which has gone largely unnoticed in the United States. Self-management intervention has been proven to be an effective intervention to increase healthy behaviors, improve overall health status, decrease healthcare utilization/cost, decrease depressive symptoms, and improve participation in people with a variety of chronic conditions; however, it has never be used with individuals with mild stroke. The critical next step and goal of this study is to evaluate if self-management intervention will improve health outcomes for persons with mild stroke. The overall hypothesis of this study is that self-management intervention will improve outcomes in the mild-stroke population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Chronic Disease Self-Management Program (CDSMP)The intervention group will receive the rehabilitation services and support that is recommended and provided in the current health care structure. The intervention group will also receive the Chronic Disease Self-Management Program (CDSMP). The CDSMP is an education program based on the concept of self-management. Self-management refers to the ability of an individual to manage the day-to-day responsibilities of living with a chronic condition. The CDSMP will be delivered in two and a half hour sessions, once a week, for six weeks, in group format. |
| Usual Care Group | No intervention | –The usual care group for this study will receive the rehabilitation services and support that is recommended and provided in the current health care structure. No additional intervention will be provided to the usual care group within this study. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a mild stroke as NIHSS total scores 0-5
- 18-90 years of age
- English speaking
- identified as having at least one other chronic condition besides stroke
Key exclusion criteria (8 listed)
- severe aphasia (NIHSS aphasia score=2)
- moderate to severe cognitive impairment (MOCA < 21)
- history of dementia
- hemorrhagic stroke
- neurological diagnoses other than stroke
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 |
|---|---|---|
| Chronic Disease Self-Management Program (CDSMP) | Behavioural | Intervention Group |
Primary outcome
Adapted Illness Intrusiveness Ratings (AIIR)
Time frame: Change from baseline to 6-months post-stroke
Healthcare Utilization Survey (HCUS)
Time frame: Change from baseline to 6-months post-stroke
8 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: Change from baseline to 6-months post-stroke
Work Ability Index (WAI)
Time frame: Change from baseline to 6-months post-stroke
Reintegration to Normal Living Index (RNLI)
Time frame: Change from baseline to 6-months post-stroke
World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: Change from baseline to 6-months post-stroke
Chronic Disease Self-Efficacy Scale (CDSES)
Time frame: Change from baseline to 6-months post-stroke
Multidimensional Assessment of Fatigue (MAF)
Time frame: Change from baseline to 6-months post-stroke
Activity Card Sort (ACS)
Time frame: Change from baseline to 6-months post-stroke
Stroke Impact Scale (SIS)
Time frame: Change from baseline to 6-months post-stroke
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 28 Apr 2016.
- Derived from this study: PubMed 34813082Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
- Performance, Participation, and Neurorehabilitation Laboratory: Timothy J. Wolf, OTD, MSCI, OTR/L (PI)Link provided by the sponsor.
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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.
Timothy J Wolf, OTD, MSCI, OTR/L principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic Disease Self-Management Program (CDSMP) in people with Stroke and Chronic Disease, run by Washington University School of Medicine 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 8 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 28 Apr 2016. 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?
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?
Adapted Illness Intrusiveness Ratings (AIIR) (time frame: Change from baseline to 6-months post-stroke). The study lists 2 primary outcomes in all. 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 NCT01770184, 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 28 Apr 2016.