Trial Outcomes & Findings for Intervention to Improve Adherence in Teen Kidney Transplant (NCT NCT01356277)
NCT ID: NCT01356277
Last Updated: 2018-07-18
Results Overview
Daily "taking adherence", defined as the percentage of prescribed doses taken each day (as measured by electronic monitoring). The daily taking adherence score could take a value of 0%, 50%, or 100% for patients on twice daily dosing, and 0% or 100% for patients on once daily dosing. Each patient had a taking adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use (due to travel etc), no score was given. To summarize adherence for each arm, we calculated the total percentage of days of observation for which there was 100% taking adherence. The denominator for this calculation was the the total number of days of observation of each participant, summed across all participants; the numerator was the total number of days of observation of each participant for which taking adherence was 100%, summed across all participants.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
170 participants
Primary outcome timeframe
12 months
Results posted on
2018-07-18
Participant Flow
1 patient withdrew after completing the enrollment visit, but before randomization.
Participant milestones
| Measure |
Behavioral Intervention
Participants in the intervention group will form an Adherence Support Team (AST), receive standardized adherence education, and complete behavioral intervention at 3-month intervals. In between visits, the study facilitator will maintain monthly contact with participants via short phone or text-message check-ins. The electronic pillbox will collect adherence data and will be configured to provide visual cue or text message dose reminders to participants in the intervention group. Participants in the intervention group will be fed back their electronic adherence data at each study visit.
Action-focused problem-solving: An Adherence Support Team (AST), consisting of the patient, one or both parents (or primary caregiver), and the study facilitator, will be formed for each participant in the intervention arm. "Action-focused problem-solving" is informed by two complementary behavioral approaches: problem-solving and implementation intentions.
Implementation intentions are concrete
|
Attention Control
Control participants will receive an electronic pillbox to measure medication adherence. They will meet with the study facilitator at 3-month intervals to discuss general health and life issues. The dose reminder functions of the electronic pillbox will not be enabled.
|
|---|---|---|
|
Run-in
STARTED
|
81
|
88
|
|
Run-in
COMPLETED
|
76
|
88
|
|
Run-in
NOT COMPLETED
|
5
|
0
|
|
Intervention Interval
STARTED
|
76
|
88
|
|
Intervention Interval
COMPLETED
|
66
|
81
|
|
Intervention Interval
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intervention to Improve Adherence in Teen Kidney Transplant
Baseline characteristics by cohort
| Measure |
Behavioral Intervention
n=81 Participants
Participants in the intervention group form an Adherence Support Team (AST), receive standardized adherence education, and complete behavioral intervention at 3-month intervals. In between visits, the study facilitator will maintain monthly contact with participants via short phone or text-message check-ins. The electronic pillbox will collect adherence data and will be configured to provide visual cue or text message dose reminders to participants in the intervention group. Participants in the intervention group will be fed back their electronic adherence data at each study visit.
Action-focused problem-solving: An Adherence Support Team (AST), consisting of the patient, one or both parents (or primary caregiver), and the study facilitator, will be formed for each participant in the intervention arm. "Action-focused problem-solving" is informed by two complementary behavioral approaches: problem-solving and implementation intentions.
Implementation intentions are concrete
|
Attention Control
n=88 Participants
Control participants will receive an electronic pillbox to measure medication adherence. They will meet with the study facilitator at 3-month intervals to discuss general health and life issues. The dose reminder functions of the electronic pillbox will not be enabled.
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.5 years
n=5 Participants
|
15.8 years
n=7 Participants
|
15.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
medication insurer
U.S. Public
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
medication insurer
Private
|
28 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
medication insurer
Canada provincial
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
household income
< $25,000
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
household income
$25,000- $50,000
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
household income
$51,000- $75,000
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
household income
$76,000- $100,000
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
household income
>$100,000
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
household income
prefer not to answer
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
household income
unknown
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
median years post-transplant
|
3.7 years
n=5 Participants
|
3.0 years
n=7 Participants
|
3.1 years
n=5 Participants
|
|
donor source
Living
|
37 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
donor source
Deceased
|
44 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
median total lifetime duration of dialysis
|
10.0 Months
n=5 Participants
|
5.0 Months
n=7 Participants
|
6.0 Months
n=5 Participants
|
|
primary disease
Congenital anomalies of the kidneys/ urinary tract
|
29 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
primary disease
glomerulonephritis
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
primary disease
Focal segmental glomerulosclerosis
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
primary disease
other
|
29 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
number of past acute rejections
0
|
59 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
number of past acute rejections
1
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
number of past acute rejections
2 or more
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
number of comorbidities
0
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
number of comorbidities
at least 1
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
number of doses of immunosuppressives per day
|
7 number of doses per day
n=5 Participants
|
7 number of doses per day
n=7 Participants
|
7 number of doses per day
n=5 Participants
|
|
pre-intervention taking adherence
|
72.8 % days with 100% taking adherence
n=5 Participants
|
74.7 % days with 100% taking adherence
n=7 Participants
|
73.8 % days with 100% taking adherence
n=5 Participants
|
|
Total Adolescent Medication Barriers scale score
|
37.5 units on a scale
STANDARD_DEVIATION 11.2 • n=5 Participants
|
38.1 units on a scale
STANDARD_DEVIATION 9.8 • n=7 Participants
|
37.7 units on a scale
STANDARD_DEVIATION 10.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: We used unadjusted ordinal logistic regression with generalized estimating equations to account for repeated measures (i.e. score on each day) to compare taking and timing adherence between the intervention and control groups during the intervention interval. An additional 'as-treated' analysis was also conducted. All available data were included.
Daily "taking adherence", defined as the percentage of prescribed doses taken each day (as measured by electronic monitoring). The daily taking adherence score could take a value of 0%, 50%, or 100% for patients on twice daily dosing, and 0% or 100% for patients on once daily dosing. Each patient had a taking adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use (due to travel etc), no score was given. To summarize adherence for each arm, we calculated the total percentage of days of observation for which there was 100% taking adherence. The denominator for this calculation was the the total number of days of observation of each participant, summed across all participants; the numerator was the total number of days of observation of each participant for which taking adherence was 100%, summed across all participants.
Outcome measures
| Measure |
Behavioral Intervention
n=64 Participants
The patient, parent and Coach formed an Adherence Support Team. The Coach delivered standardized education on immunosuppressive medications, identified adherence barriers using the AMBS/PMBS and the last 3 months of electronic monitoring data and then used 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient.
Action-focused problem-solving involved brainstorming possible solutions to a barrier, rating the potential solutions, and selecting one solution to implement following the session. The solution was concrete and took the form of an "If/when…then…" statement. Intervention participants could choose to receive text message, email, or visual cue dose reminders. At subsequent sessions the Coach, patient, and parent jointly reviewed the electronic adherence monitoring data from the prior 3 mo to identify adherence patterns and guide the development and revision of action plans.
|
Attention Control
n=74 Participants
Control group study visits were conducted at the same intervals as intervention visits and consisted of the Coach engaging in active listening and providing non-specific support only. Adherence was NOT discussed with control participants.
|
|---|---|---|
|
Taking Adherence
|
78 % of days with 100% taking adherence
|
68 % of days with 100% taking adherence
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: We used unadjusted ordinal logistic regression with generalized estimating equations to account for repeated measures (i.e. score on each day) to compare timing adherence between the intervention and control groups during the intervention interval. An additional 'as-treated' analysis was also conducted. All available data were included.
Daily "timing adherence", defined as the percentage of doses taken within 1 hour before to 2 hours after the prescribed dosing time each day (as measured by electronic monitoring). The daily timing adherence score could take a value of 0%, 50%, or 100% for patients on twice daily dosing, and 0% or 100% for patients on once daily dosing. Each patient had a timing adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use (due to travel etc), no score was given. To summarize timing adherence for each arm, we calculated the total percentage of days of observation for which there was 100% timing adherence. The denominator for this calculation was the the total number of days of observation of each participant, summed across all participants; the numerator was the total number of days of observation of each participant for which timing adherence was 100%, summed across all participants.
Outcome measures
| Measure |
Behavioral Intervention
n=64 Participants
The patient, parent and Coach formed an Adherence Support Team. The Coach delivered standardized education on immunosuppressive medications, identified adherence barriers using the AMBS/PMBS and the last 3 months of electronic monitoring data and then used 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient.
Action-focused problem-solving involved brainstorming possible solutions to a barrier, rating the potential solutions, and selecting one solution to implement following the session. The solution was concrete and took the form of an "If/when…then…" statement. Intervention participants could choose to receive text message, email, or visual cue dose reminders. At subsequent sessions the Coach, patient, and parent jointly reviewed the electronic adherence monitoring data from the prior 3 mo to identify adherence patterns and guide the development and revision of action plans.
|
Attention Control
n=74 Participants
Control group study visits were conducted at the same intervals as intervention visits and consisted of the Coach engaging in active listening and providing non-specific support only. Adherence was NOT discussed with control participants.
|
|---|---|---|
|
Timing Adherence
|
73 % of days with 100% timing adherence
|
61 % of days with 100% timing adherence
|
SECONDARY outcome
Timeframe: 12 monthsThe SD of all tacrolimus trough levels done for clinical care (except during hospitalizations or illnesses) were calculated for participants with \>=3 tacrolimus levels.
Outcome measures
| Measure |
Behavioral Intervention
n=58 Participants
The patient, parent and Coach formed an Adherence Support Team. The Coach delivered standardized education on immunosuppressive medications, identified adherence barriers using the AMBS/PMBS and the last 3 months of electronic monitoring data and then used 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient.
Action-focused problem-solving involved brainstorming possible solutions to a barrier, rating the potential solutions, and selecting one solution to implement following the session. The solution was concrete and took the form of an "If/when…then…" statement. Intervention participants could choose to receive text message, email, or visual cue dose reminders. At subsequent sessions the Coach, patient, and parent jointly reviewed the electronic adherence monitoring data from the prior 3 mo to identify adherence patterns and guide the development and revision of action plans.
|
Attention Control
n=63 Participants
Control group study visits were conducted at the same intervals as intervention visits and consisted of the Coach engaging in active listening and providing non-specific support only. Adherence was NOT discussed with control participants.
|
|---|---|---|
|
Standard Deviation (SD) of Tacrolimus Trough Levels
|
1.6 standard deviation units
Interval 0.9 to 2.5
|
1.4 standard deviation units
Interval 0.9 to 2.1
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: included all those who participated during the intervention interval
Self-reported taking adherence, assessed using the Medical Adherence Measure- Medication Module (MAM-MM), was scored as the proportion of doses taken in the previous week. MAM-MM scores for each patient were summarized as the mean of the four scores post-intervention.
Outcome measures
| Measure |
Behavioral Intervention
n=76 Participants
The patient, parent and Coach formed an Adherence Support Team. The Coach delivered standardized education on immunosuppressive medications, identified adherence barriers using the AMBS/PMBS and the last 3 months of electronic monitoring data and then used 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient.
Action-focused problem-solving involved brainstorming possible solutions to a barrier, rating the potential solutions, and selecting one solution to implement following the session. The solution was concrete and took the form of an "If/when…then…" statement. Intervention participants could choose to receive text message, email, or visual cue dose reminders. At subsequent sessions the Coach, patient, and parent jointly reviewed the electronic adherence monitoring data from the prior 3 mo to identify adherence patterns and guide the development and revision of action plans.
|
Attention Control
n=88 Participants
Control group study visits were conducted at the same intervals as intervention visits and consisted of the Coach engaging in active listening and providing non-specific support only. Adherence was NOT discussed with control participants.
|
|---|---|---|
|
Self-reported Taking Adherence
|
98.3 percentage of prescribed doses taken
Standard Deviation 4.5
|
97.1 percentage of prescribed doses taken
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: included all those who participated during the intervention interval
Self-reported timing adherence, assessed using the Medical Adherence Measure- Medication Module (MAM-MM), was scored as the proportion of doses taken up to 2 hours after the prescribed time in the previous week. MAM-MM scores for each patient were summarized as the mean of the four scores post-intervention.
Outcome measures
| Measure |
Behavioral Intervention
n=76 Participants
The patient, parent and Coach formed an Adherence Support Team. The Coach delivered standardized education on immunosuppressive medications, identified adherence barriers using the AMBS/PMBS and the last 3 months of electronic monitoring data and then used 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient.
Action-focused problem-solving involved brainstorming possible solutions to a barrier, rating the potential solutions, and selecting one solution to implement following the session. The solution was concrete and took the form of an "If/when…then…" statement. Intervention participants could choose to receive text message, email, or visual cue dose reminders. At subsequent sessions the Coach, patient, and parent jointly reviewed the electronic adherence monitoring data from the prior 3 mo to identify adherence patterns and guide the development and revision of action plans.
|
Attention Control
n=88 Participants
Control group study visits were conducted at the same intervals as intervention visits and consisted of the Coach engaging in active listening and providing non-specific support only. Adherence was NOT discussed with control participants.
|
|---|---|---|
|
Self-reported Timing Adherence
|
95.0 percentage of doses taken on time
Standard Deviation 7.9
|
92.9 percentage of doses taken on time
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: included all those who participated during the intervention interval
The acute rejection rate, measured as rejections per 100 person-years of observation.
Outcome measures
| Measure |
Behavioral Intervention
n=76 Participants
The patient, parent and Coach formed an Adherence Support Team. The Coach delivered standardized education on immunosuppressive medications, identified adherence barriers using the AMBS/PMBS and the last 3 months of electronic monitoring data and then used 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient.
Action-focused problem-solving involved brainstorming possible solutions to a barrier, rating the potential solutions, and selecting one solution to implement following the session. The solution was concrete and took the form of an "If/when…then…" statement. Intervention participants could choose to receive text message, email, or visual cue dose reminders. At subsequent sessions the Coach, patient, and parent jointly reviewed the electronic adherence monitoring data from the prior 3 mo to identify adherence patterns and guide the development and revision of action plans.
|
Attention Control
n=88 Participants
Control group study visits were conducted at the same intervals as intervention visits and consisted of the Coach engaging in active listening and providing non-specific support only. Adherence was NOT discussed with control participants.
|
|---|---|---|
|
Acute Rejection Rate
|
1.06 events per 100 person-years
|
1.69 events per 100 person-years
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: included all those with eGFR data available
Change in estimated glomerular filtration rate, estimated using the Schwartz equation for those \< 18 y. and the CKD-EPI equation for those 18y and older, standardized to a 12-month period.
Outcome measures
| Measure |
Behavioral Intervention
n=66 Participants
The patient, parent and Coach formed an Adherence Support Team. The Coach delivered standardized education on immunosuppressive medications, identified adherence barriers using the AMBS/PMBS and the last 3 months of electronic monitoring data and then used 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient.
Action-focused problem-solving involved brainstorming possible solutions to a barrier, rating the potential solutions, and selecting one solution to implement following the session. The solution was concrete and took the form of an "If/when…then…" statement. Intervention participants could choose to receive text message, email, or visual cue dose reminders. At subsequent sessions the Coach, patient, and parent jointly reviewed the electronic adherence monitoring data from the prior 3 mo to identify adherence patterns and guide the development and revision of action plans.
|
Attention Control
n=81 Participants
Control group study visits were conducted at the same intervals as intervention visits and consisted of the Coach engaging in active listening and providing non-specific support only. Adherence was NOT discussed with control participants.
|
|---|---|---|
|
Annualized Change in Estimated Glomerular Filtration Rate (eGFR)
|
-2.3 ml/min/1.73m^2
Interval -10.6 to 2.3
|
-3.3 ml/min/1.73m^2
Interval -7.7 to 3.7
|
Adverse Events
Multi-component Intervention
Serious events: 24 serious events
Other events: 42 other events
Deaths: 0 deaths
Attention Control
Serious events: 30 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Multi-component Intervention
n=76 participants at risk
* Adherence Support Team (patient, parent, Coach)
* standardized education on immunosuppressive medications
* identification of adherence barriers
* Electronic adherence monitoring with feedback of past 3 months of electronic monitoring data at 3-month intervals
* 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient
* text message, email, or visual cue dose reminders
|
Attention Control
n=88 participants at risk
* Electronic adherence monitoring
* meetings with Coach at 3 month intervals
|
|---|---|---|
|
General disorders
Hospitalizations
|
31.6%
24/76 • Number of events 42 • 12 months
The standard definitions were used.
|
33.0%
29/88 • Number of events 54 • 12 months
The standard definitions were used.
|
|
Blood and lymphatic system disorders
PTLD
|
0.00%
0/76 • 12 months
The standard definitions were used.
|
1.1%
1/88 • Number of events 2 • 12 months
The standard definitions were used.
|
Other adverse events
| Measure |
Multi-component Intervention
n=76 participants at risk
* Adherence Support Team (patient, parent, Coach)
* standardized education on immunosuppressive medications
* identification of adherence barriers
* Electronic adherence monitoring with feedback of past 3 months of electronic monitoring data at 3-month intervals
* 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient
* text message, email, or visual cue dose reminders
|
Attention Control
n=88 participants at risk
* Electronic adherence monitoring
* meetings with Coach at 3 month intervals
|
|---|---|---|
|
Renal and urinary disorders
acute rejection
|
10.5%
8/76 • Number of events 9 • 12 months
The standard definitions were used.
|
11.4%
10/88 • Number of events 17 • 12 months
The standard definitions were used.
|
|
Infections and infestations
CMV infection
|
5.3%
4/76 • Number of events 5 • 12 months
The standard definitions were used.
|
0.00%
0/88 • 12 months
The standard definitions were used.
|
|
Infections and infestations
influenza infection
|
3.9%
3/76 • Number of events 3 • 12 months
The standard definitions were used.
|
5.7%
5/88 • Number of events 5 • 12 months
The standard definitions were used.
|
|
Infections and infestations
other infection
|
18.4%
14/76 • Number of events 20 • 12 months
The standard definitions were used.
|
23.9%
21/88 • Number of events 31 • 12 months
The standard definitions were used.
|
|
Gastrointestinal disorders
vomiting/diarrhea
|
5.3%
4/76 • Number of events 5 • 12 months
The standard definitions were used.
|
3.4%
3/88 • Number of events 3 • 12 months
The standard definitions were used.
|
|
Surgical and medical procedures
surgery/procedure
|
6.6%
5/76 • Number of events 7 • 12 months
The standard definitions were used.
|
6.8%
6/88 • Number of events 6 • 12 months
The standard definitions were used.
|
|
General disorders
Abdominal pain
|
5.3%
4/76 • Number of events 5 • 12 months
The standard definitions were used.
|
8.0%
7/88 • Number of events 8 • 12 months
The standard definitions were used.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place