Behavioral Contract Adherence Intervention
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Behavioral Contract Intervention to Improve Adherence Among Renal Transplant Recipients|
- Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Immunosuppressant therapy adherence as measured by pharmacy refill records. Adherence was calculated quarterly for one year by using the number of days between prescription (IST) refills. If the total number of days between refills was less than or equal to the total days' supply of IST, the participant's adherence rate was 1.0, or 100%. If the number of days between refills was greater than the days' supply, the adherence rate was calculated as follows:
1 - [(Days Between Refills - Total Days Supply)/Days Between Refills] = Adherence Rate for Quarterly Time Period
At the end of the 12-month study period, the quarterly adherence rates were averaged to produce an overall adherence rate for the study period.
- Health-related Quality of Life (HQoL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]The EQ-5D is a multi-attribute, preference-based HQoL instrument. Considered a global HQoL measure, the EQ-5D is a descriptive system that classifies respondents into one of 243 distinct health states based on five dimensions (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has three levels, reflecting "no problems," "some problems," and "extreme problems." A scoring function assigns a value (EQ-5DIndex score) to self-reported health states from a set of preference weights that have been empirically derived. The EQ-5D's total scale (preference value) range is from 0 to 1.0. On this scale, the preference value of 1.0 represents perfect health and 0.0 represents death. Preference values less than 0 are possible, but not reflected on the scale, and reflect health states that the U.S. population consider worse than death.
- Days in Hospital [ Time Frame: 12 months ] [ Designated as safety issue: No ]
We used a standardized patient reporting approach to collect direct healthcare utilizations data, including days in hospital. A brief healthcare screening questionnaire was administered to both the intervention and control groups on a monthly basis during the one-year study period. Monthly recall periods were chosen to minimize bias and forgetfulness. The questionnaire collected the number of times each month a participant utilized a direct medical service, specifically, days in hospital, emergency department (ED) visit, outpatient visit (clinic, physician office), and home healthcare visit.
Analysis compared proportion of each group who had at least one day in hospital during the 12-month study period.
|Study Start Date:||January 2010|
|Study Completion Date:||June 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Intervention Group
Behavioral contract intervention
Behavioral: Behavioral Contract
Intervention activities were performed by a study clinical pharmacist. Behavioral contract goal was achieving and maintaining IST adherence. Other components of the contract addressed: (a) motivation(s) or positive reinforcement for achieving IST adherence; (b) problems or barriers that may interfere with achieving IST adherence and possible solutions to overcome problems/barriers; (c) social support available to the RTR such as a significant other who may assist the RTR in following the IST dosing schedule; (d) tools/strategies the RTR may use to remind himself/herself to follow the IST dosing schedule; and (e) possible consequences of IST nonadherence (e.g., graft loss).
No Intervention: Control Group
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739803
|United States, Arizona|
|University of Arizona College of Pharmacy|
|Tucson, Arizona, United States, 85721|
|Principal Investigator:||Marie A Chisholm-Burns, PharmD||University of Tennessee College of Pharmacy|