StrokeNCT03253601
iADAPT to Support Strategy Training After Stroke
A study testing Strategy Training in people with Stroke and Adherence, Patient, run by University of Pittsburgh at 1 site in United States.
Trial summary
Adherence to rehabilitation interventions is associated with functional outcomes (e.g. independence in daily activities, return of motor function) after stroke. Low adherence to rehabilitation home programs is common after stroke. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Stroke, Adherence, Patient, Strategy Training
- What is being tested?
- Strategy Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 31 Dec 2019
- 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 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Diagnosis of Stroke
Who cannot join
- prior exposure to Strategy Training
- vision impairment that impairs ability to read device screen or worksheet
- poor self-awareness (score of ≥2 on Self Awareness of Deficits Inventory item #1 or #2
- current major depressive, bipolar, or psychotic disorder (Patient Health Questionnaire-9, PRIME-MD)
- current alcohol or drug abuse (Mini International Neuropsychiatric Interview)
- severe aphasia (score ≤1 on Boston Diagnostic Aphasia Examination)
- current diagnosis of dementia, neurodegenerative disease, or cancer
- anticipated discharge to a skilled nursing facility
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Adherence to rehabilitation interventions is associated with functional outcomes (e.g. independence in daily activities, return of motor function) after stroke. Low adherence to rehabilitation home programs is common after stroke. Interventions delivered via mobile health applications demonstrated positive effects on adherence to health behaviors (e.g. medication routines, smoking cessation). The investigators developed the iADAPT mobile application to support adherence to Strategy Training. Strategy Training is an iterative rehabilitation intervention the promotes goal setting, planning, and self-monitoring after stroke. This study examines the effects of the iADAPT mobile health application relative to a workbook on adherence to Strategy Training after stroke.
- Conditions
- Stroke, Adherence, Patient, Strategy Training
- Being tested
- Strategy Training
- Keywords
- Rehabilitation, Disability, Mobile Health Technology
- Medical subject headings
- Stroke, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategy TrainingBehavioural
Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice.
| Study group | Role | What they receive |
|---|---|---|
| Strategy Training: iADAPT Application | Experimental | Participants will use the iADAPT mobile health application to supplement to in-person and remote intervention sessions. Receives: Behavioral: Strategy Training |
| Strategy Training: Workbook | Active comparator | Participants will use a printed workbook to supplement to in-person and remote (by telephone) intervention sessions. Receives: Behavioral: Strategy Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence: Observed client behavior
Number of completed activity trials in the iADAPT application or Workbook
Measured: Baseline to 3 months
Adherence: Client-reported progress on goals.
Client rating of independence with self-selected goals (measured using Canadian Occupational Performance Measure)
Measured: Baseline and 3 months
Secondary outcomes (1)
Adherence: Client perspectives on treatment environment
Client rating on patient-provider connection and treatment expectancy measured by Healing Encounters and Attitudes Lists
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start14 Aug 2017
- Primary completion8 Jul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth R. Skidmore, PhD, OTR/L, University of Pittsburgh
- Investigators
- Elizabeth R. Skidmore, PhD, OTR/L, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253601
- Sponsor's protocol ID
- PRO17030372
- Status last verified
- Jul 2020
- First submitted
- 14 Aug 2017
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iADAPT to Support Strategy Training After Stroke
- ClinicalTrials.gov ID
- NCT03253601
- Acronym / sponsor ID
- PRO17030372
- Conditions
- Stroke, Adherence, Patient, Strategy Training
- Keywords
- Rehabilitation, Disability, Mobile Health Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 8 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Aug 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.
Adherence to rehabilitation interventions is associated with functional outcomes (e.g. independence in daily activities, return of motor function) after stroke. Low adherence to rehabilitation home programs is common after stroke. Interventions delivered via mobile health applications demonstrated positive effects on adherence to health behaviors (e.g. medication routines, smoking cessation). The investigators developed the iADAPT mobile application to support adherence to Strategy Training. Strategy Training is an iterative rehabilitation intervention the promotes goal setting, planning, and self-monitoring after stroke. This study examines the effects of the iADAPT mobile health application relative to a workbook on adherence to Strategy Training after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strategy Training: iADAPT Application | Experimental | Behavioral: Strategy TrainingParticipants will use the iADAPT mobile health application to supplement to in-person and remote intervention sessions. |
| Strategy Training: Workbook | Active comparator | Behavioral: Strategy TrainingParticipants will use a printed workbook to supplement to in-person and remote (by telephone) intervention sessions. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Diagnosis of Stroke
Key exclusion criteria (8 listed)
- prior exposure to Strategy Training
- vision impairment that impairs ability to read device screen or worksheet
- poor self-awareness (score of ≥2 on Self Awareness of Deficits Inventory item #1 or #2
- current major depressive, bipolar, or psychotic disorder (Patient Health Questionnaire-9, PRIME-MD)
- current alcohol or drug abuse (Mini International Neuropsychiatric Interview)
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 |
|---|---|---|
| Strategy TrainingStrategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice. | Behavioural | Strategy Training: Workbook, Strategy Training: iADAPT Application |
Primary outcome
Adherence: Observed client behavior
Time frame: Baseline to 3 months
Number of completed activity trials in the iADAPT application or Workbook
Adherence: Client-reported progress on goals.
Time frame: Baseline and 3 months
Client rating of independence with self-selected goals (measured using Canadian Occupational Performance Measure)
1 secondary outcome
Adherence: Client perspectives on treatment environment
Time frame: Baseline and 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 2 Jul 2020.
- 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.
Elizabeth R. Skidmore, PhD, OTR/L principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategy Training in people with Stroke and Adherence, Patient, run by University of Pittsburgh 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 1 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 2 Jul 2020. 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?
Adherence: Observed client behavior (time frame: Baseline to 3 months). 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?
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 2 Jul 2020.