Trial Outcomes & Findings for Transplant Regimen Adherence for Kidney Recipients by Engaging Information Technologies: The TAKE IT Trial (NCT NCT03104868)
NCT ID: NCT03104868
Last Updated: 2024-09-19
Results Overview
An in-person pill count using established guidelines will be conducted. When in-person interviews are not possible, pill count will be done over the phone. Adherence will be assessed within drugs. The proportion of pills taken/pills prescribed will be calculated per medication. Patients will be considered non-adherent for a medication if this score is \<=80% and adherent if pills taken/pill prescribed\>80% (0=non-adherent, 1=adherent).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
449 participants
Primary outcome timeframe
1 year - 1.5 years
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Usual Care
Patients in this group will receive the usual standard of care.
|
Intervention
Patients in this group will receive the Transplant regimen Adherence for Kidney recipients by Engaging Information Technologies (TAKE IT) strategy components.
TAKE IT Strategy: The TAKE IT Strategy includes:
1. Programming the electronic health record (EHR) to organize/simplify daily regimen schedules and generate electronic, tangible, print, low literacy medication education materials at every clinical encounter.
2. Short Message Service (SMS) text-messaging to remind patients when to take all their medicine.
3. A web-based patient portal that requests patients to periodically report upon their medication use, providing a continuous link between the transplant center and patient beyond routine in-person visits.
4. EHR notifications directed to the transplant center nurse coordinator if an adherence-related problem is identified by the web-based portal assessment, who then can activate appropriate staff to respond.
|
|---|---|---|
|
Baseline
STARTED
|
225
|
224
|
|
Baseline
COMPLETED
|
225
|
224
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
6 Week Follow up
STARTED
|
225
|
224
|
|
6 Week Follow up
COMPLETED
|
188
|
187
|
|
6 Week Follow up
NOT COMPLETED
|
37
|
37
|
|
6 Month Follow up
STARTED
|
212
|
209
|
|
6 Month Follow up
COMPLETED
|
188
|
174
|
|
6 Month Follow up
NOT COMPLETED
|
24
|
35
|
|
12 Month Follow up
STARTED
|
210
|
206
|
|
12 Month Follow up
COMPLETED
|
177
|
171
|
|
12 Month Follow up
NOT COMPLETED
|
33
|
35
|
|
18 Month Follow up
STARTED
|
209
|
200
|
|
18 Month Follow up
COMPLETED
|
179
|
165
|
|
18 Month Follow up
NOT COMPLETED
|
30
|
35
|
|
24 Month Follow up
STARTED
|
198
|
185
|
|
24 Month Follow up
COMPLETED
|
177
|
167
|
|
24 Month Follow up
NOT COMPLETED
|
21
|
18
|
Reasons for withdrawal
| Measure |
Usual Care
Patients in this group will receive the usual standard of care.
|
Intervention
Patients in this group will receive the Transplant regimen Adherence for Kidney recipients by Engaging Information Technologies (TAKE IT) strategy components.
TAKE IT Strategy: The TAKE IT Strategy includes:
1. Programming the electronic health record (EHR) to organize/simplify daily regimen schedules and generate electronic, tangible, print, low literacy medication education materials at every clinical encounter.
2. Short Message Service (SMS) text-messaging to remind patients when to take all their medicine.
3. A web-based patient portal that requests patients to periodically report upon their medication use, providing a continuous link between the transplant center and patient beyond routine in-person visits.
4. EHR notifications directed to the transplant center nurse coordinator if an adherence-related problem is identified by the web-based portal assessment, who then can activate appropriate staff to respond.
|
|---|---|---|
|
6 Week Follow up
Lost to Follow-up
|
5
|
8
|
|
6 Week Follow up
Death
|
1
|
1
|
|
6 Week Follow up
Withdrawal by Subject
|
7
|
6
|
|
6 Week Follow up
Completed Later Timepoint
|
24
|
22
|
|
6 Month Follow up
Lost to Follow-up
|
2
|
2
|
|
6 Month Follow up
Death
|
0
|
1
|
|
6 Month Follow up
Completed Later Timepoint
|
22
|
32
|
|
12 Month Follow up
Lost to Follow-up
|
1
|
2
|
|
12 Month Follow up
Death
|
0
|
1
|
|
12 Month Follow up
Withdrawal by Subject
|
0
|
3
|
|
12 Month Follow up
Completed Later Timepoint
|
32
|
29
|
|
18 Month Follow up
Lost to Follow-up
|
7
|
11
|
|
18 Month Follow up
Death
|
2
|
1
|
|
18 Month Follow up
Withdrawal by Subject
|
1
|
2
|
|
18 Month Follow up
Graft Loss
|
1
|
1
|
|
18 Month Follow up
Completed Later Timepoint
|
19
|
20
|
|
24 Month Follow up
Lost to Follow-up
|
15
|
16
|
|
24 Month Follow up
Death
|
3
|
2
|
|
24 Month Follow up
Withdrawal by Subject
|
1
|
0
|
|
24 Month Follow up
Graft Loss
|
2
|
0
|
Baseline Characteristics
Transplant Regimen Adherence for Kidney Recipients by Engaging Information Technologies: The TAKE IT Trial
Baseline characteristics by cohort
| Measure |
Usual Care
n=225 Participants
Patients in this group will receive the usual standard of care.
|
Intervention
n=224 Participants
Patients in this group will receive the TAKE IT strategy components.
TAKE IT Strategy: The TAKE IT Strategy includes:
1. Programming the electronic health record (EHR) to organize/simplify daily regimen schedules and generate electronic, tangible, print, low literacy medication education materials at every clinical encounter.
2. SMS text-messaging to remind patients when to take all their medicine.
3. A web-based patient portal that requests patients to periodically report upon their medication use, providing a continuous link between the transplant center and patient beyond routine in-person visits.
4. EHR notifications directed to the transplant center nurse coordinator if an adherence-related problem is identified by the web-based portal assessment, who then can activate appropriate staff to respond.
|
Total
n=449 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
183 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
369 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
51.9 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
177 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
31 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
161 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
307 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Recruitment Site
Northwestern Medicine
|
124 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
|
Recruitment Site
Mayo Clinic - Arizona
|
101 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Time Since Transplant
|
10.0 month
STANDARD_DEVIATION 8.2 • n=5 Participants
|
9.7 month
STANDARD_DEVIATION 8.1 • n=7 Participants
|
9.9 month
STANDARD_DEVIATION 8.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year - 1.5 yearsPopulation: Analyses included a pill count collected at 1 year or at 1.5 years if a pill count was not collected at 1 year. Observations were excluded if: 1.Medications were not in pill form; 2.Participants couldn't provide accurate quantities on their bottles; 3.Missing Fill or Start Dates, 4.Participants started their medications that day; 5. Pro re nata (PRN) Medications.
An in-person pill count using established guidelines will be conducted. When in-person interviews are not possible, pill count will be done over the phone. Adherence will be assessed within drugs. The proportion of pills taken/pills prescribed will be calculated per medication. Patients will be considered non-adherent for a medication if this score is \<=80% and adherent if pills taken/pill prescribed\>80% (0=non-adherent, 1=adherent).
Outcome measures
| Measure |
Usual Care
n=439 Medications
Patients in this group will receive the usual standard of care.
|
Intervention
n=402 Medications
Patients in this group will receive the TAKE IT strategy components.
TAKE IT Strategy: The TAKE IT Strategy includes:
1. Programming the electronic health record (EHR) to organize/simplify daily regimen schedules and generate electronic, tangible, print, low literacy medication education materials at every clinical encounter.
2. SMS text-messaging to remind patients when to take all their medicine.
3. A web-based patient portal that requests patients to periodically report upon their medication use, providing a continuous link between the transplant center and patient beyond routine in-person visits.
4. EHR notifications directed to the transplant center nurse coordinator if an adherence-related problem is identified by the web-based portal assessment, who then can activate appropriate staff to respond.
|
|---|---|---|
|
Rx Pill Count
|
0.26 Probability of adherence (1/0)
Interval 0.22 to 0.3
|
0.26 Probability of adherence (1/0)
Interval 0.22 to 0.3
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Observations were excluded if participants did not complete the 24-hour recall questions.
Patients are asked to self-report 1) proper dose (# pills), 2) spacing (hours between doses), 3) frequency (times per day), and 4) total pills/day for each prescribed medication over the last 24 hours. Responses are coded as correct or incorrect. Patients will be scored 'yes' if they have demonstrated proper use by correctly reporting all components of the medicine.
Outcome measures
| Measure |
Usual Care
n=893 Medications
Patients in this group will receive the usual standard of care.
|
Intervention
n=904 Medications
Patients in this group will receive the TAKE IT strategy components.
TAKE IT Strategy: The TAKE IT Strategy includes:
1. Programming the electronic health record (EHR) to organize/simplify daily regimen schedules and generate electronic, tangible, print, low literacy medication education materials at every clinical encounter.
2. SMS text-messaging to remind patients when to take all their medicine.
3. A web-based patient portal that requests patients to periodically report upon their medication use, providing a continuous link between the transplant center and patient beyond routine in-person visits.
4. EHR notifications directed to the transplant center nurse coordinator if an adherence-related problem is identified by the web-based portal assessment, who then can activate appropriate staff to respond.
|
|---|---|---|
|
Correct Medication Dosing Over Past 24 Hours (24 Hour Recall)
|
0.89 Probability of Adherence (1/0)
Interval 0.87 to 0.91
|
0.88 Probability of Adherence (1/0)
Interval 0.86 to 0.9
|
SECONDARY outcome
Timeframe: 1 yearPopulation: We discovered the wrong timepoint was used in the original analysis. Results were updated in March 2024.
The Ask-12 is a self-report scale that assesses general medication attitudes and beliefs. The scale consists of 12 items across three domains (inconvenience/forgetfulness, treatment beliefs, and behaviors), with responses ranging from "Strongly Disagree" to "Strongly Agree". Score can range from 12-60 with higher scores representing greater barriers to adherence.
Outcome measures
| Measure |
Usual Care
n=177 Participants
Patients in this group will receive the usual standard of care.
|
Intervention
n=171 Participants
Patients in this group will receive the TAKE IT strategy components.
TAKE IT Strategy: The TAKE IT Strategy includes:
1. Programming the electronic health record (EHR) to organize/simplify daily regimen schedules and generate electronic, tangible, print, low literacy medication education materials at every clinical encounter.
2. SMS text-messaging to remind patients when to take all their medicine.
3. A web-based patient portal that requests patients to periodically report upon their medication use, providing a continuous link between the transplant center and patient beyond routine in-person visits.
4. EHR notifications directed to the transplant center nurse coordinator if an adherence-related problem is identified by the web-based portal assessment, who then can activate appropriate staff to respond.
|
|---|---|---|
|
Ask-12
|
18.4 score on a scale (12-60)
Interval 17.1 to 19.2
|
17.7 score on a scale (12-60)
Interval 16.9 to 18.5
|
SECONDARY outcome
Timeframe: Value at 2 years minus value at baselinePopulation: Participants were analyzed if we were able to retrieve a baseline and 2 year eGFR value from the chart to calculate change. Results were updated in March 2024 after receiving additional data from Mayo Clinic.
Change in eGFR (estimated glomerular filtration rate), ml/min/1.73m\^2 over 2 years. Values were not adjusted for race.
Outcome measures
| Measure |
Usual Care
n=198 Participants
Patients in this group will receive the usual standard of care.
|
Intervention
n=197 Participants
Patients in this group will receive the TAKE IT strategy components.
TAKE IT Strategy: The TAKE IT Strategy includes:
1. Programming the electronic health record (EHR) to organize/simplify daily regimen schedules and generate electronic, tangible, print, low literacy medication education materials at every clinical encounter.
2. SMS text-messaging to remind patients when to take all their medicine.
3. A web-based patient portal that requests patients to periodically report upon their medication use, providing a continuous link between the transplant center and patient beyond routine in-person visits.
4. EHR notifications directed to the transplant center nurse coordinator if an adherence-related problem is identified by the web-based portal assessment, who then can activate appropriate staff to respond.
|
|---|---|---|
|
Change in Estimated Glomerular Filtration Rate (eGFR), ml/Min/1.73m^2
|
-0.68 ml/min/1.73m^2
Interval -2.12 to 0.77
|
-0.76 ml/min/1.73m^2
Interval -2.21 to 0.69
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants were included if they completed the hospitalization items.
Acute care hospitalizations post transplant. Hospitalizations were self-reported at the 24 month interview and counted if they occurred after the baseline interview.
Outcome measures
| Measure |
Usual Care
n=173 Participants
Patients in this group will receive the usual standard of care.
|
Intervention
n=162 Participants
Patients in this group will receive the TAKE IT strategy components.
TAKE IT Strategy: The TAKE IT Strategy includes:
1. Programming the electronic health record (EHR) to organize/simplify daily regimen schedules and generate electronic, tangible, print, low literacy medication education materials at every clinical encounter.
2. SMS text-messaging to remind patients when to take all their medicine.
3. A web-based patient portal that requests patients to periodically report upon their medication use, providing a continuous link between the transplant center and patient beyond routine in-person visits.
4. EHR notifications directed to the transplant center nurse coordinator if an adherence-related problem is identified by the web-based portal assessment, who then can activate appropriate staff to respond.
|
|---|---|---|
|
Re-hospitalization
|
0.59 probability of re-hospitalization
Interval 0.47 to 0.75
|
0.59 probability of re-hospitalization
Interval 0.46 to 0.75
|
Adverse Events
Usual Care
Serious events: 3 serious events
Other events: 0 other events
Deaths: 6 deaths
Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Usual Care
n=225 participants at risk
Patients in this group will receive the usual standard of care.
|
Intervention
n=224 participants at risk
Patients in this group will receive the TAKE IT strategy components.
TAKE IT Strategy: The TAKE IT Strategy includes:
1. Programming the electronic health record (EHR) to organize/simplify daily regimen schedules and generate electronic, tangible, print, low literacy medication education materials at every clinical encounter.
2. SMS text-messaging to remind patients when to take all their medicine.
3. A web-based patient portal that requests patients to periodically report upon their medication use, providing a continuous link between the transplant center and patient beyond routine in-person visits.
4. EHR notifications directed to the transplant center nurse coordinator if an adherence-related problem is identified by the web-based portal assessment, who then can activate appropriate staff to respond.
|
|---|---|---|
|
Renal and urinary disorders
Graft Loss After Kidney Transplantation
|
1.3%
3/225 • Number of events 3 • 24 months
|
0.45%
1/224 • Number of events 1 • 24 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place