Anemia, Sickle CellNCT02857023
Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease
A study testing Cogmed RM in people with Anemia, Sickle Cell, run by Steven J. Hardy at 1 site in United States.
Trial summary
Disease-related neurocognitive deficits are common in pediatric sickle cell disease (SCD). These deficits can significantly disrupt otherwise normal trajectories toward academic and vocational achievement and negatively impact psychosocial outcomes. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Anemia, Sickle Cell
- What is being tested?
- Cogmed RM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Aug 2018
- 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with sickle cell disease (HbSS, HbSC, or HbS-beta thalassemia).
- 7 to 16 years old.
- An absolute or relative working memory deficit.
- IQ of 70 or greater, as measured via the WISC-V.
- Presence of a caregiver who is willing and capable of providing consistent support and supervision during Cogmed training.
Who cannot join
- Visual, motor, or auditory impairment that prevents computer use.
- Insufficient English fluency.
- Started taking or adjusted dose of medication to treat symptoms of ADHD in the last 30 days.
- Unreliable access to a source of electricity to charge an iPad battery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Health System
Washington D.C., District of Columbia, 20010
About this study
Disease-related neurocognitive deficits are common in pediatric sickle cell disease (SCD). These deficits can significantly disrupt otherwise normal trajectories toward academic and vocational achievement and negatively impact psychosocial outcomes. Despite widespread recognition of neurocognitive deficits, there are no treatments shown to maintain or recover functioning once a child with SCD endures neuronal damage. Cognitive training (CT) has been a standard intervention used to stabilize and recover functioning in individuals with accidental or disease-related brain injury. Recent advances in technology have led to the development of computerized CT programs. This study seeks to assess the feasibility and efficacy of using computerized CT with pediatric patients with SCD. Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed). Feasibility will be assessed by examining participation, retention, and program completion rates, as well as feedback from a feasibility and acceptability questionnaire and a brief qualitative interview. Participants will also complete assessments of attention, working memory, and academic fluency at baseline and immediately following the intervention. A final assessment will be conducted 6 months after the conclusion of the intervention to evaluate the stability of treatment effects.
- Conditions
- Anemia, Sickle Cell
- Being tested
- Cogmed RM
- Keywords
- Neurocognitive, Working memory, Cogmed, Cognitive training
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogmed RMBehavioural
Cogmed consists of 12 increasingly challenging exercises (completed over 25 sessions spanning 5-8 weeks) that target skills involving visuo-spatial and verbal working memory.
| Study group | Role | What they receive |
|---|---|---|
| Cogmed intervention | Experimental | Cogmed RM Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed) Receives: Behavioral: Cogmed RM |
| Cogmed-waitlist control | Experimental | Cogmed RM Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed) Receives: Behavioral: Cogmed RM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cogmed feasibility assessed by program completion rates
Feasibility will be determined by examining the proportion of the sample that completes at least 20 Cogmed sessions (i.e., 80% of the program) within the allotted time frame (10-week maximum).
Measured: Following completion of Cogmed (approximately 8-10 weeks from baseline)
Secondary outcomes (3)
Verbal working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Digit Span subtest
Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Digit Span subtest after completing Cogmed.
Measured: Baseline, 8-10 weeks, 6-month follow-up
Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Picture Span subtest
Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Picture Span subtest after completing Cogmed.
Measured: Baseline, 8-10 weeks, 6-month follow-up
Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Spatial Span subtest
Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Spatial Span subtest after completing Cogmed.
Measured: Baseline, 8-10 weeks, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startOct 2014
- Primary completionJul 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Sickle CellStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven J. Hardy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steven J. Hardy, Children's National Research Institute
- Investigators
- Steven Hardy, PhD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857023
- Sponsor's protocol ID
- Pro00004421
- Other IDs
- 2013141
- Status last verified
- Nov 2018
- First submitted
- 28 Jul 2016
- Last updated
- 23 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02857023
- Acronym / sponsor ID
- Pro00004421
- Conditions
- Anemia, Sickle Cell
- Keywords
- Neurocognitive, Working memory, Cogmed, Cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Steven J. HardyUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 5 Aug 2016 (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.
Disease-related neurocognitive deficits are common in pediatric sickle cell disease (SCD). These deficits can significantly disrupt otherwise normal trajectories toward academic and vocational achievement and negatively impact psychosocial outcomes. Despite widespread recognition of neurocognitive deficits, there are no treatments shown to maintain or recover functioning once a child with SCD endures neuronal damage. Cognitive training (CT) has been a standard intervention used to stabilize and recover functioning in individuals with accidental or disease-related brain injury. Recent advances in technology have led to the development of computerized CT programs. This study seeks to assess the feasibility and efficacy of using computerized CT with pediatric patients with SCD. Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed). Feasibility will be assessed by examining participation, retention, and program completion rates, as well as feedback from a feasibility and acceptability questionnaire and a brief qualitative interview. Participants will also complete assessments of attention, working memory, and academic fluency at baseline and immediately following the intervention. A final assessment will be conducted 6 months after the conclusion of the intervention to evaluate the stability of treatment effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cogmed intervention | Experimental | Behavioral: Cogmed RMCogmed RM Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed) |
| Cogmed-waitlist control | Experimental | Behavioral: Cogmed RMCogmed RM Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed) |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosed with sickle cell disease (HbSS, HbSC, or HbS-beta thalassemia).
- 7 to 16 years old.
- An absolute or relative working memory deficit.
- IQ of 70 or greater, as measured via the WISC-V.
- Presence of a caregiver who is willing and capable of providing consistent support and supervision during Cogmed training.
Key exclusion criteria (4 listed)
- Visual, motor, or auditory impairment that prevents computer use.
- Insufficient English fluency.
- Started taking or adjusted dose of medication to treat symptoms of ADHD in the last 30 days.
- Unreliable access to a source of electricity to charge an iPad battery.
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 |
|---|---|---|
| Cogmed RMCogmed consists of 12 increasingly challenging exercises (completed over 25 sessions spanning 5-8 weeks) that target skills involving visuo-spatial and verbal working memory. | Behavioural | Cogmed intervention, Cogmed-waitlist control |
Primary outcome
Cogmed feasibility assessed by program completion rates
Time frame: Following completion of Cogmed (approximately 8-10 weeks from baseline)
Feasibility will be determined by examining the proportion of the sample that completes at least 20 Cogmed sessions (i.e., 80% of the program) within the allotted time frame (10-week maximum).
3 secondary outcomes
Verbal working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Digit Span subtest
Time frame: Baseline, 8-10 weeks, 6-month follow-up
Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Picture Span subtest
Time frame: Baseline, 8-10 weeks, 6-month follow-up
Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Spatial Span subtest
Time frame: Baseline, 8-10 weeks, 6-month follow-up
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 23 Nov 2018.
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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.
Steven Hardy, PhD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cogmed RM in people with Anemia, Sickle Cell, run by Steven J. Hardy 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 5 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: finished, as of the sponsor's last update on 23 Nov 2018. 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?
Cogmed feasibility assessed by program completion rates (time frame: Following completion of Cogmed (approximately 8-10 weeks from baseline)). 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 23 Nov 2018.