Multiple SclerosisNCT02234713

Adherence in Pediatric Multiple Sclerosis

A study testing Motivational Interview in people with Multiple Sclerosis, run by The Hospital for Sick Children at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 10 to 18 years
Conditions the study is for: Multiple Sclerosis
What is being tested?: Motivational Interview
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 13 sitesin 2 countries
Study dates: Jan 2013to Sep 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 10 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Adolescent boys/girls who are 10 to 17 years 11 months old;
Have a diagnosis of MS, as per revised McDonald diagnostic criteria and International Pediatric MS Study Group criteria;
Prescribed with an oral or injectable disease-modifying therapy for MS for at least six months.

Who cannot join

Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities. This is indicative of not having a true diagnosis of MS.
Patients on IV DMT will not be included in the study.
Non-English speaking patients

Trial locations and contacts

13 sites in 2 countries.

Country

City, postcode or hospital

13 sites in 2 countries

United States11 sites

University of Alabama
Birmingham, Alabama, 35294
Boston Children's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic
Cleveland, Ohio, 44195
University of Colorado at Denver
Denver, Colorado, 80202
Baylor College of Medicine
Houston, Texas, 77030
Loma Linda University
Loma Linda, California, 92354
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
The Regents of the University of California, San Francisco
San Francisco, California, 94143
Washington University
St Louis, Missouri, 63130

Other trials in United States

Canada2 sites

Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

Official title: Treatment Adherence in Pediatric Multiple Sclerosis

Disease modifying therapies (DMT) are widely used for children and adolescents with MS. Nonetheless, many pediatric patients continue to relapse and therefore require changes in therapy. We designed this research study to learn more about medication use in children and adolescents with MS. We are also interested in learning what a behavioral feedback intervention can tell us about adherence to medicine. Finally, we hope this research project will inform the way we provide clinical care for children and adolescents with MS.

Conditions: Multiple Sclerosis
Being tested: Motivational Interview, Video Attention Control
Medical subject headings: Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Motivational InterviewBehavioural
Video Attention ControlOther

Study groups in NCT02234713
Study group	Role	What they receive
Behavioural Intervention/Feedback	Experimental	The behavioral interventionist will contact the patient and parent by email and telephone to schedule a telephone call to review the downloaded adherence information and discuss barriers experienced by the patient/parent using a standard script. The behavioral feedback will be administered three times: at 1-, 2- and 3-months post-baseline. Receives: Behavioral: Motivational Interview
Video Attention Control	Active comparator	The patients in this arm of the study will be emailed a link to an educational video about Pediatric MS and therapy for MS at three time points: 1-, 2-, and 3-months post-baseline. Receives: Other: Video Attention Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Level of Adherence in Subjects (Objective Measure)
Objective measures included: (A) pharmacy refill data provided by site coordinators for 12 months prior to study entry and for 6 months post-study entry and (B) the MEMS cap, an EM device (MEMS, AARDEX) that captures each time the patient discards a needle from their injection or opens their pill bottle. Adherence information from MEMS caps is downloaded and stored on a secured web-platform (medAmigo™). These data were used to compile drug-dosing history data and to calculate medication adherence during the course of the study.
Measured: Baseline, 3 months, 6 months
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ
Multiple Sclerosis Treatment Adherence Questionnaire (MSTAQ): Assesses missed doses, side effects and barriers of taking DMTs, and behavioral coping strategies used (e.g., icing the injection site, taking pain medication) over the past four weeks. We adapted the MSTAQ to include both oral and injectable medications. We used a standardized scoring algorithm (0-100), where higher scores reflected higher numbers of missed doses, side effects, barriers, or behavioral coping strategies. Subjects completed only the barriers items, and the parent completed all items.
Measured: Baseline, 3 months, 6 months
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky
Morisky Adherence Scale (Morisky): A widely used 8-item patient-/parent-reported measure with documented reliability and validity. Total scores range from 0 to 8.The following scoring algorithm was used: 8 = high adherence, 6-7 = medium adherence, and <6=low adherence.
Measured: Baseline, 3 months, 6 months
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement
Parental involvement in DMT administration (Parental Involvement): Percentage of time the parent reported (1) reminding the child to take her/his DMT; (2) being present when the child took her/his DMT; and (3) administering the child's DMT.
Measured: Baseline, 3 months, 6 months

Secondary outcomes (2)

Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL
Pediatric Quality of Life Inventory (PedsQL): A 23-item tool with subscales for physical, social, emotional, and school functioning. The PedsQL has documented reliability and validity, and has been used in a large number of pediatric quality-of-life studies. Subscale scores range from 0 to 100 with higher scores representing better functioning.
Measured: Baseline, 3 months, 6 months
Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ
Multiple Sclerosis Neuropsychological Screening Assessment Questionnaire (MSNQ): Neurocognitive Functioning will be assessed using the informant-report version of the Multiple Sclerosis Neuropsychological Screening Assessment Questionnaire (MSNQ). This 15-item tool has documented high test-retest stability, predictive validity, and construct validity. Informant reports are documented to be reliably correlated with cognitive dysfunction and be less biased by patient depression. Total scores range from 0 to 60 with a higher score indicating worse cognitive functioning.
Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Sep 2016

First posted9 Sep 2014 (estimated)
Study startJan 2013
Primary completionJul 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Multiple SclerosisStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02234713
Sponsor's protocol ID: 1000035924
Other IDs: HC 0148
Status last verified: Jan 2020
First submitted: 5 Sep 2014
Last updated: 18 Jan 2020
Results posted: Yes, on ClinicalTrials.gov

Publications

Yeh EA, Chiang N, Darshan B, Nejati N, Grover SA, Schwartz CE, Slater R, Finlayson M; Pediatric MS Adherence Study Group. Adherence in Youth With Multiple Sclerosis: A Qualitative Assessment of Habit Formation, Barriers, and Facilitators. Qual Health Res. 2019 Apr;29(5):645-657. doi: 10.1177/1049732318779039. Epub 2018 Jun 17.
PubMed 29911511
Yeh EA, Grover SA, Powell VE, Alper G, Banwell BL, Edwards K, Gorman M, Graves J, Lotze TE, Mah JK, Mednick L, Ness J, Obadia M, Slater R, Waldman A, Waubant E, Schwartz CE; Pediatric MS Adherence Study Group. Correction to: Impact of an electronic monitoring device and behavioural feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial. Qual Life Res. 2018 Apr;27(4):1117. doi: 10.1007/s11136-017-1773-4.
PubMed 29274015
Yeh EA, Grover SA, Powell VE, Alper G, Banwell BL, Edwards K, Gorman M, Graves J, Lotze TE, Mah JK, Mednick L, Ness J, Obadia M, Slater R, Waldman A, Waubant E, Schwartz CE; Pediatric MS Adherence Study Group. Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial. Qual Life Res. 2017 Sep;26(9):2333-2349. doi: 10.1007/s11136-017-1571-z. Epub 2017 Apr 9.
PubMed 28393317
Schwartz CE, Grover SA, Powell VE, Noguera A, Mah JK, Mar S, Mednick L, Banwell BL, Alper G, Rensel M, Gorman M, Waldman A, Schreiner T, Waubant E, Yeh EA. Risk factors for non-adherence to disease-modifying therapy in pediatric multiple sclerosis. Mult Scler. 2018 Feb;24(2):175-185. doi: 10.1177/1352458517695469. Epub 2017 Feb 1.
PubMed 28273780

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment Adherence in Pediatric Multiple Sclerosis
ClinicalTrials.gov ID: NCT02234713
Acronym / sponsor ID: 1000035924
Conditions: Multiple Sclerosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: The Hospital for Sick ChildrenUniversity, hospital or other
Collaborators: National Multiple Sclerosis Society, Loma Linda University, University of Pittsburgh, Children's Hospital of Philadelphia, Boston Children's Hospital, Baylor College of Medicine, University of Alabama at Birmingham, Mayo Clinic, University of Colorado, Denver, University of California, San Francisco, Washington University School of Medicine, Alberta Children's Hospital, The Cleveland Clinic, DeltaQuest Foundation
Study start: Jan 2013
Primary completion: Jul 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 9 Sep 2014 (estimated)
Results: Posted 18 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Behavioural Intervention/Feedback	Experimental	Behavioral: Motivational InterviewThe behavioral interventionist will contact the patient and parent by email and telephone to schedule a telephone call to review the downloaded adherence information and discuss barriers experienced by the patient/parent using a standard script. The behavioral feedback will be administered three times: at 1-, 2- and 3-months post-baseline.
Video Attention Control	Active comparator	Other: Video Attention ControlThe patients in this arm of the study will be emailed a link to an educational video about Pediatric MS and therapy for MS at three time points: 1-, 2-, and 3-months post-baseline.

Who may qualify

Ages: 10 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Adolescent boys/girls who are 10 to 17 years 11 months old;
Have a diagnosis of MS, as per revised McDonald diagnostic criteria and International Pediatric MS Study Group criteria;
Prescribed with an oral or injectable disease-modifying therapy for MS for at least six months.

Key exclusion criteria (3 listed)

Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities. This is indicative of not having a true diagnosis of MS.
Patients on IV DMT will not be included in the study.
Non-English speaking patients

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
Motivational Interview	Behavioural	Behavioural Intervention/Feedback
Video Attention Control	Other	Video Attention Control

Primary outcome

Change in Level of Adherence in Subjects (Objective Measure)
Time frame: Baseline, 3 months, 6 months
Objective measures included: (A) pharmacy refill data provided by site coordinators for 12 months prior to study entry and for 6 months post-study entry and (B) the MEMS cap, an EM device (MEMS, AARDEX) that captures each time the patient discards a needle from their injection or opens their pill bottle. Adherence information from MEMS caps is downloaded and stored on a secured web-platform (medAmigo™). These data were used to compile drug-dosing history data and to calculate medication adherence during the course of the study.
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ
Time frame: Baseline, 3 months, 6 months
Multiple Sclerosis Treatment Adherence Questionnaire (MSTAQ): Assesses missed doses, side effects and barriers of taking DMTs, and behavioral coping strategies used (e.g., icing the injection site, taking pain medication) over the past four weeks. We adapted the MSTAQ to include both oral and injectable medications. We used a standardized scoring algorithm (0-100), where higher scores reflected higher numbers of missed doses, side effects, barriers, or behavioral coping strategies. Subjects completed only the barriers items, and the parent completed all items.
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky
Time frame: Baseline, 3 months, 6 months
Morisky Adherence Scale (Morisky): A widely used 8-item patient-/parent-reported measure with documented reliability and validity. Total scores range from 0 to 8.The following scoring algorithm was used: 8 = high adherence, 6-7 = medium adherence, and <6=low adherence.
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement
Time frame: Baseline, 3 months, 6 months
Parental involvement in DMT administration (Parental Involvement): Percentage of time the parent reported (1) reminding the child to take her/his DMT; (2) being present when the child took her/his DMT; and (3) administering the child's DMT.

2 secondary outcomes

Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL
Time frame: Baseline, 3 months, 6 months
Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ
Time frame: Baseline, 3 months, 6 months

Results and safety

Results posted to the registry on 18 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Behavioural Intervention/Feedback	31	25
Video Attention Control	32	27

Primary outcome: Change in Level of Adherence in Subjects (Objective Measure)

Time frame: Baseline, 3 months, 6 months. Mean (Standard Deviation). Unit: Proportion of doses (actual vs expected)

Measure	Baseline n = 51	3-month Follow up n = 52	6-month Follow up n = 49
Pharmacy refill adherence	0.95 (0.12)	0.86 (0.20)	0.85 (0.22)
MEMs cap adherence	0.81 (0.22)	0.82 (0.18)	0.66 (0.32)

Population analysed: Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)

Primary outcome: Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ

Time frame: Baseline, 3 months, 6 months. Mean (Standard Deviation). Unit: Score on a scale

Measure	Baseline n = 47	3-month Follow up n = 45	6-month Follow up n = 47
Parent MSTAQ missed doses	0.06 (0.18)	0.07 (0.19)	0.07 (0.22)
Parent MSTAQ behavioural coping strategies	49.64 (9.58)	49.24 (8.28)	49.33 (10.76)
Parent MSTAQ side effects	50.03 (9.63)	49.48 (9.58)	49.04 (10.63)
Parent MSTAQ barriers	50.12 (10.42)	48.66 (8.60)	49.31 (9.74)
Patient MSTAQ barriers	48.88 (9.22)	50.40 (9.57)	50.09 (10.90)

Population analysed: Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)

Primary outcome: Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky

Time frame: Baseline, 3 months, 6 months. Mean (Standard Deviation). Unit: Score on a scale

Measure	Baseline n = 52	3-month Follow up n = 48	6-month Follow up n = 49
Parent Morisky	6.28 (1.46)	6.40 (1.50)	6.20 (1.85)
Patient Morisky	5.93 (1.74)	6.00 (1.82)	5.94 (1.91)

Population analysed: Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)

Primary outcome: Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement

Time frame: Baseline, 3 months, 6 months. Mean (Standard Deviation). Unit: Percentage of time

Measure	Baseline n = 51	3-month Follow up n = 48	6-month Follow up n = 49
Parent remind	44.61 (38.83)	37.50 (37.90)	33.16 (34.76)
Parent present	65.20 (37.11)	55.21 (39.26)	57.14 (39.53)
Parent administer	36.27 (41.33)	32.81 (41.95)	30.10 (40.82)

Population analysed: Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Behavioural Intervention/Feedback	0 of 25 (0%)	0 of 25 (0%)	Not reported
Video Attention Control	0 of 27 (0%)	0 of 27 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29911511Yeh EA, Chiang N, Darshan B, Nejati N, Grover SA, Schwartz CE, Slater R, Finlayson M; Pediatric MS Adherence Study Group. Adherence in Youth With Multiple Sclerosis: A Qualitative Assessment of Habit Formation, Barriers, and Facilitators. Qual Health Res. 2019 Apr;29(5):645-657. doi: 10.1177/1049732318779039. Epub 2018 Jun 17.
Derived from this study: PubMed 29274015Yeh EA, Grover SA, Powell VE, Alper G, Banwell BL, Edwards K, Gorman M, Graves J, Lotze TE, Mah JK, Mednick L, Ness J, Obadia M, Slater R, Waldman A, Waubant E, Schwartz CE; Pediatric MS Adherence Study Group. Correction to: Impact of an electronic monitoring device and behavioural feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial. Qual Life Res. 2018 Apr;27(4):1117. doi: 10.1007/s11136-017-1773-4.
Derived from this study: PubMed 28393317Yeh EA, Grover SA, Powell VE, Alper G, Banwell BL, Edwards K, Gorman M, Graves J, Lotze TE, Mah JK, Mednick L, Ness J, Obadia M, Slater R, Waldman A, Waubant E, Schwartz CE; Pediatric MS Adherence Study Group. Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial. Qual Life Res. 2017 Sep;26(9):2333-2349. doi: 10.1007/s11136-017-1571-z. Epub 2017 Apr 9.
Derived from this study: PubMed 28273780Schwartz CE, Grover SA, Powell VE, Noguera A, Mah JK, Mar S, Mednick L, Banwell BL, Alper G, Rensel M, Gorman M, Waldman A, Schreiner T, Waubant E, Yeh EA. Risk factors for non-adherence to disease-modifying therapy in pediatric multiple sclerosis. Mult Scler. 2018 Feb;24(2):175-185. doi: 10.1177/1352458517695469. Epub 2017 Feb 1.

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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.

E. Ann Yeh, MD principal investigator

University of Toronto, The Hospital for Sick Children

13 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Interview in people with Multiple Sclerosis, run by The Hospital for Sick Children at 13 sites in 2 countries.

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 3 inclusion and 3 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Level of Adherence in Subjects (Objective Measure) (time frame: Baseline, 3 months, 6 months). The study lists 4 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 NCT02234713, which also lists 4 linked publications.

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 18 Jan 2020.