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China Adherence Through Technology Study (CATS)

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ClinicalTrials.gov Identifier: NCT01722552
Recruitment Status : Completed
First Posted : November 7, 2012
Results First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Collaborators:
FHI 360
Guangxi Center for Disease Control and Prevention
Dimagi Inc.
Massachusetts General Hospital
Information provided by (Responsible Party):
Lora Sabin, Boston University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Medication Adherence
Interventions Behavioral: adherence feedback
Behavioral: standard of care
Enrollment 120
Recruitment Details We recruited subjects from December 2012-April 2013. They were recruited at the Guangxi Provincial ART clinic in Nanning, China. Patients were eligible if they were receiving or initiating antiretroviral therapy (ART), aged 18 years or above, deemed at risk for poor adherence by clinic staff or patients themselves, and owned a mobile phone.
Pre-assignment Details After enrollment, each subject was given a Wisepill electronic adherence monitoring container for use with his/her ART medications. Subjects selected one or more ART medications to be monitored within the device. All subjects underwent baseline adherence monitoring using Wisepill for 3 months before randomization.
Arm/Group Title Adherence Feedback
Hide Arm/Group Description

Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.

adherence feedback

Period Title: Overall Study
Started 120 [1]
Completed 116 [2]
Not Completed 4
[1]
Number of subjects enrolled
[2]
Number of subjects who completed the intervention
Arm/Group Title Adherence Feedback
Hide Arm/Group Description

Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.

adherence feedback

Overall Number of Baseline Participants 63
Hide Baseline Analysis Population Description
Intervention arm baseline information
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants
36.9  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
21
  33.3%
Male
42
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
American Indian or Alaska Native
0
   0.0%
Asian
63
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Difference in Proportion of Subjects Who Achieve >/= 95% Adherence
Hide Description Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.
Time Frame Measured at 6 months after start of intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adherence Feedback Control
Hide Arm/Group Description:

Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.

adherence feedback

Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
Overall Number of Participants Analyzed 63 56
Measure Type: Count of Participants
Unit of Measure: Participants
55
  87.3%
29
  51.8%
2.Secondary Outcome
Title Proportion of Subjects Who Achieve >/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period
Hide Description Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adherence Feedback Control
Hide Arm/Group Description:

Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.

adherence feedback

Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
Overall Number of Participants Analyzed 63 56
Measure Type: Count of Participants
Unit of Measure: Participants
52
  82.5%
29
  51.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adherence Feedback, Control
Comments The primary analysis was by intent to treat (ITT). This included data for all randomized subjects, with post-intervention adherence measured by the last 30 days of available data; adherence over the entire 6-month intervention period was measured using all available post-intervention data. Our sample size was designed to detect a 25 percentage point difference in proportion achieving optimal adherence post-intervention.
Type of Statistical Test Equivalence
Comments The margin for non-equivalence was 25 percentage points.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.59
Confidence Interval (2-Sided) 95%
1.21 to 2.1
Estimation Comments [Not Specified]
Time Frame Data collection took place from December 2012 and April 2014.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adherence Feedback Control
Hide Arm/Group Description

Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.

adherence feedback

Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
All-Cause Mortality
Adherence Feedback Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adherence Feedback Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   0/56 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adherence Feedback Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   0/56 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Lora Sabin
Organization: Boston University School of Public Health
Phone: 617-414-1272 ext 617
EMail: lsabin@bu.edu
Responsible Party: Lora Sabin, Boston University
ClinicalTrials.gov Identifier: NCT01722552     History of Changes
Other Study ID Numbers: 1R34DA032423-01A1 ( U.S. NIH Grant/Contract )
First Submitted: November 3, 2012
First Posted: November 7, 2012
Results First Submitted: March 11, 2017
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017