Inflammatory Bowel DiseasePHONENCT01237847
A Brief Intervention to Improve Adherence in Teens With Inflammatory Bowel Disease
A study testing 2 Family-based problem solving phone sessions, 4 Family-based problem solving phone intervention sessions and Wait list comparison group in people with Inflammatory Bowel Disease, run by Rosalind Franklin University of Medicine and Science at 1 site in United States.
Trial summary
This project will test if a phone intervention can improve the medicine-taking behavior of teens with IBD. The investigators will study teens who are taking medicine by mouth. The investigators will test if two phone calls that help teens solve problems with their IBD medicine help to increase how often teens take… Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- 2 Family-based problem solving phone sessions, 4 Family-based problem solving phone intervention sessions and Wait list comparison group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2013
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patient age 11-18 years
- patient English speaking
- patient legal guardian willing to participate
- patient on oral IBD maintenance medication for 3 months or longer
Who cannot join
- history of significant parent-reported cognitive or developmental delay
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53213
About this study
This project will test if a phone intervention can improve the medicine-taking behavior of teens with IBD. The investigators will study teens who are taking medicine by mouth. The investigators will test if two phone calls that help teens solve problems with their IBD medicine help to increase how often teens take their medicine. The study will also see if there is any extra benefit of more sessions (four compared to two). The investigators will ask 90 teens to be in the study. Teens can be in the study if they are 11-18 years old and speak English. They must also take an IBD medication by mouth and have a parent who also wants to be in the study. Teens who agree to be in the study will fill out forms at the beginning (participant week 0), middle (participant week 12), and end of the study (participant week 20). After assessment 1, they will be randomly assigned to either receive 2 phone calls or a wait list group (participant weeks 6-10). After that, they will complete a second assessment. After the second assessment, teens who got the 2 phone calls right will be re-randomized to two more sessions or no more sessions (participant weeks 14-18). Teens who were in the wait list group will get two phone sessions (participant weeks 14-18). After that, there will be a final assessment (participant week 20). The investigators expect the phone intervention sessions to reduce barriers to medicine taking, improve medicine taking, and improve teen quality of life.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- 2 Family-based problem solving phone sessions, 4 Family-based problem solving phone intervention sessions, Wait list comparison group
- Keywords
- inflammatory bowel disease, IBD, Crohn's disease, ulcerative colitis, adolescent
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 Family-based problem solving phone sessionsBehavioural
2 family-based problem solving phone sessions to address and ameliorate barriers to adherence.
4 Family-based problem solving phone intervention sessionsBehavioural
4 family-based problem solving phone sessions to address and ameliorate barriers to adherence.
Wait list comparison groupBehavioural
Wait list comparison group to receive intervention at later point.
| Study group | Role | What they receive |
|---|---|---|
| Wait List | Other | Not described Receives: Behavioral: Wait list comparison group |
| 2 phone sessions | Experimental | Not described Receives: Behavioral: 2 Family-based problem solving phone sessions |
| 4 phone sessions | Experimental | Not described Receives: Behavioral: 4 Family-based problem solving phone intervention sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
participants will use MEMS bottles to capture adherence data from participant week 0 - participant week 20. Additionally, adherence interviews and pill counts will be conducted at participant week 0, 12, and 20.
Measured: beginning at baseline - week 20
Secondary outcomes (2)
Quality of Life
Measured: at baseline, week 12, and week 20
Adherence barriers
Measured: at baseline, week 12, and week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2012 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rosalind Franklin University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- Medical College of Wisconsin, Children's Hospital and Health System Foundation, Wisconsin
- Investigators
- Rachel Neff Greenley, PhD, Principal investigator, Rosalind Franklin University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237847
- Sponsor's protocol ID
- CCFA#2838
- Acronym
- PHONE
- Status last verified
- Nov 2010
- First submitted
- 9 Nov 2010
- Last updated
- 10 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391Greenley RN, Gumidyala AP, Nguyen E, Plevinsky JM, Poulopoulos N, Thomason MM, Walter JG, Wojtowicz AA, Blank E, Gokhale R, Kirschner BS, Miranda A, Noe JD, Stephens MC, Werlin S, Kahn SA. Can You Teach a Teen New Tricks? Problem Solving Skills Training Improves Oral Medication Adherence in Pediatric Patients with Inflammatory Bowel Disease Participating in a Randomized Trial. Inflamm Bowel Dis. 2015 Nov;21(11):2649-57. doi: 10.1097/MIB.0000000000000530.
PubMed 26218142
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Intervention to Improve Adherence in Teens With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT01237847
- Acronym / sponsor ID
- PHONE / CCFA#2838
- Conditions
- Inflammatory Bowel Disease
- Keywords
- inflammatory bowel disease, IBD, Crohn's disease, ulcerative colitis, adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Rosalind Franklin University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- Medical College of Wisconsin, Children's Hospital and Health System Foundation, Wisconsin
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 10 Nov 2010 (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.
This project will test if a phone intervention can improve the medicine-taking behavior of teens with IBD. The investigators will study teens who are taking medicine by mouth. The investigators will test if two phone calls that help teens solve problems with their IBD medicine help to increase how often teens take their medicine. The study will also see if there is any extra benefit of more sessions (four compared to two). The investigators will ask 90 teens to be in the study. Teens can be in the study if they are 11-18 years old and speak English. They must also take an IBD medication by mouth and have a parent who also wants to be in the study. Teens who agree to be in the study will fill out forms at the beginning (participant week 0), middle (participant week 12), and end of the study (participant week 20). After assessment 1, they will be randomly assigned to either receive 2 phone calls or a wait list group (participant weeks 6-10). After that, they will complete a second assessment. After the second assessment, teens who got the 2 phone calls right will be re-randomized to two more sessions or no more sessions (participant weeks 14-18). Teens who were in the wait list group will get two phone sessions (participant weeks 14-18). After that, there will be a final assessment (participant week 20). The investigators expect the phone intervention sessions to reduce barriers to medicine taking, improve medicine taking, and improve teen quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wait List | Other | Behavioral: Wait list comparison group |
| 2 phone sessions | Experimental | Behavioral: 2 Family-based problem solving phone sessions |
| 4 phone sessions | Experimental | Behavioral: 4 Family-based problem solving phone intervention sessions |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- patient age 11-18 years
- patient English speaking
- patient legal guardian willing to participate
- patient on oral IBD maintenance medication for 3 months or longer
Key exclusion criteria (1 listed)
- history of significant parent-reported cognitive or developmental delay
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 |
|---|---|---|
| 2 Family-based problem solving phone sessions2 family-based problem solving phone sessions to address and ameliorate barriers to adherence. | Behavioural | 2 phone sessions |
| 4 Family-based problem solving phone intervention sessions4 family-based problem solving phone sessions to address and ameliorate barriers to adherence. | Behavioural | 4 phone sessions |
| Wait list comparison groupWait list comparison group to receive intervention at later point. | Behavioural | Wait List |
Primary outcome
Adherence
Time frame: beginning at baseline - week 20
participants will use MEMS bottles to capture adherence data from participant week 0 - participant week 20. Additionally, adherence interviews and pill counts will be conducted at participant week 0, 12, and 20.
2 secondary outcomes
Quality of Life
Time frame: at baseline, week 12, and week 20
Adherence barriers
Time frame: at baseline, week 12, and week 20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2010.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
- Derived from this study: PubMed 26218142Greenley RN, Gumidyala AP, Nguyen E, Plevinsky JM, Poulopoulos N, Thomason MM, Walter JG, Wojtowicz AA, Blank E, Gokhale R, Kirschner BS, Miranda A, Noe JD, Stephens MC, Werlin S, Kahn SA. Can You Teach a Teen New Tricks? Problem Solving Skills Training Improves Oral Medication Adherence in Pediatric Patients with Inflammatory Bowel Disease Participating in a Randomized Trial. Inflamm Bowel Dis. 2015 Nov;21(11):2649-57. doi: 10.1097/MIB.0000000000000530.
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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.
Rachel Neff Greenley, PhD principal investigator
Rosalind Franklin University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 Family-based problem solving phone sessions, 4 Family-based problem solving phone intervention sessions and Wait list comparison group in people with Inflammatory Bowel Disease, run by Rosalind Franklin University of Medicine and Science 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 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: status not confirmed, as of the sponsor's last update on 10 Nov 2010. 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?
Results are not available in the source record.
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 (time frame: beginning at baseline - week 20). 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 NCT01237847, which also lists 2 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 10 Nov 2010.