Trial Outcomes & Findings for Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD) (NCT NCT01692743)
NCT ID: NCT01692743
Last Updated: 2019-09-16
Results Overview
Disease activity measure for patients with Crohn's disease. The activity index is comprised of 5 items. General well being (0-4), abdominal pain (0-3), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam (0-3), and complications (1 point per item). The total score is the sum of the individual parameters with scores less than 5 consistent with clinical remission. The minimum score is 0 and there is no pre-specified maximum score as it depends on the number of liquids stools.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
348 participants
Primary outcome timeframe
12 months
Results posted on
2019-09-16
Participant Flow
Participant milestones
| Measure |
Standard of Care
Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.
|
Weekly Home Monitoring
Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
|
Home Monitoring Every Other Week
Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
|
|---|---|---|---|
|
Overall Study
STARTED
|
117
|
116
|
115
|
|
Overall Study
COMPLETED
|
90
|
81
|
88
|
|
Overall Study
NOT COMPLETED
|
27
|
35
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)
Baseline characteristics by cohort
| Measure |
Standard of Care
n=117 Participants
Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.
|
Weekly Home Monitoring
n=116 Participants
Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
|
Home Monitoring Every Other Week
n=115 Participants
Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
|
Total
n=348 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
36.4 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
40.1 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
38.9 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
197 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
344 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
319 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Quality of Life (IBDQ)
|
168.1 units on a scale
STANDARD_DEVIATION 34 • n=5 Participants
|
172.3 units on a scale
STANDARD_DEVIATION 34.5 • n=7 Participants
|
172.3 units on a scale
STANDARD_DEVIATION 33.1 • n=5 Participants
|
171.0 units on a scale
STANDARD_DEVIATION 33.8 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Crohn's disease population
Disease activity measure for patients with Crohn's disease. The activity index is comprised of 5 items. General well being (0-4), abdominal pain (0-3), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam (0-3), and complications (1 point per item). The total score is the sum of the individual parameters with scores less than 5 consistent with clinical remission. The minimum score is 0 and there is no pre-specified maximum score as it depends on the number of liquids stools.
Outcome measures
| Measure |
Standard of Care
n=79 Participants
Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.
|
Weekly Home Monitoring
n=78 Participants
Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
|
Home Monitoring Every Other Week
n=79 Participants
Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
|
|---|---|---|---|
|
Harvey Bradshaw Index
|
3.7 units on a scale
Standard Deviation 3.6
|
3.2 units on a scale
Standard Deviation 3.4
|
4.2 units on a scale
Standard Deviation 3.9
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: IBDQ Scores
Description: A quality of life (QoL) questionnaire for patients with inflammatory bowel diseases \[1\]. Format: 32 questions grouped into four dimensions: bowel, systemic, social, and emotional. Scoring: Scores for each question range from 1 (poorest QoL) to 7 (best QoL). The overall range for the 32 item questionnaire is 32-224 with higher scores indicate better QoL. Scores \>168 have been shown to correlate with clinical remission in patients with Crohn's disease and a change in score of 16-32 points is considered significant.
Outcome measures
| Measure |
Standard of Care
n=117 Participants
Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.
|
Weekly Home Monitoring
n=116 Participants
Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
|
Home Monitoring Every Other Week
n=115 Participants
Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
|
|---|---|---|---|
|
Inflammatory Bowel Disease Questionnaire
|
179.3 units on a scale
Standard Deviation 28.2
|
179.2 units on a scale
Standard Deviation 32.8
|
181.5 units on a scale
Standard Deviation 28.2
|
SECONDARY outcome
Timeframe: One yearTotal healthcare encounters 1 year post randomization (a specific scale was not used, simple counts of all encounters after randomization were carried out)
Outcome measures
| Measure |
Standard of Care
n=117 Participants
Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America.
|
Weekly Home Monitoring
n=116 Participants
Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
|
Home Monitoring Every Other Week
n=115 Participants
Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
|
|---|---|---|---|
|
Health Care Utilization
|
2435 Encounters
|
2167 Encounters
|
2481 Encounters
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Weekly Home Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home Monitoring Every Other Week
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Raymond K. Cross, MD, MS, AGAF
University of Maryland School of Medicine
Phone: 410-706-3387
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place