Adherence Enhancement for Renal Transplant Patients
Primary Purpose
Renal Failure, Medication Adherence, Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure focused on measuring renal failure, medication adherence, hypertension
Eligibility Criteria
Inclusion Criteria:
- Persons > 21 years of age
- first time recipient of a solitary kidney transplant
- prescribed at least 3 medications for immunosuppression and hypertension
- previous history of non-adherence
- functioning kidney transplant
- ability to speak, hear and understand English
- able to use medication delivery device and self administer medications
- able to operate blood pressure monitor
- comfortable using cell phone
- no other diagnosis that might shorten lifespan
- transplant physician's assent that the patient can participate
Exclusion Criteria:
- failure to meet all inclusion criteria
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Care
mHealth
Arm Description
Standard Care after kidney transplantation
subjects provided with electronic medication tray, electronic blood pressure cuff, and a smart phone.
Outcomes
Primary Outcome Measures
medication adherence
adherence to immunosuppressive medications
Secondary Outcome Measures
blood pressure
resting blood pressure
Full Information
NCT ID
NCT01859273
First Posted
May 17, 2013
Last Updated
June 8, 2016
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT01859273
Brief Title
Adherence Enhancement for Renal Transplant Patients
Official Title
Adherence Enhancement for Renal Transplant Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Despite significant advances in the care of kidney transplant recipients, long term graft survival after renal transplantation remains suboptimal. Medication nonadherence and clinical inertia are key contributors to graft loss. The purpose of the proposed RCT feasibility study is to evaluate impact of a "bundled" wireless real time medication reminder system and blood pressure monitoring system in combination with a cognitive behavioral adherence skills enhancement program upon medication adherence, therapeutic drug concentration, and blood pressure, in nonadherent kidney transplant recipients with hypertension. We propose to recruit 60 kidney transplant recipients in phase 1 with 20 non-adherent continuing to phase 2 for a 5-month feasibility RCT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Medication Adherence, Hypertension
Keywords
renal failure, medication adherence, hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard Care after kidney transplantation
Arm Title
mHealth
Arm Type
Experimental
Arm Description
subjects provided with electronic medication tray, electronic blood pressure cuff, and a smart phone.
Intervention Type
Behavioral
Intervention Name(s)
mHealth
Intervention Description
mHealth prototype system consisting of electronic medication tray, blood pressure cuff and smart phone
Primary Outcome Measure Information:
Title
medication adherence
Description
adherence to immunosuppressive medications
Time Frame
5 months
Secondary Outcome Measure Information:
Title
blood pressure
Description
resting blood pressure
Time Frame
5 months
Other Pre-specified Outcome Measures:
Title
acceptability
Description
patients' willingness to utilize the protocol mHealth system
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persons > 21 years of age
first time recipient of a solitary kidney transplant
prescribed at least 3 medications for immunosuppression and hypertension
previous history of non-adherence
functioning kidney transplant
ability to speak, hear and understand English
able to use medication delivery device and self administer medications
able to operate blood pressure monitor
comfortable using cell phone
no other diagnosis that might shorten lifespan
transplant physician's assent that the patient can participate
Exclusion Criteria:
failure to meet all inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
john w mcgillicuddy, md
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
7871562
Citation
De Geest S, Borgermans L, Gemoets H, Abraham I, Vlaminck H, Evers G, Vanrenterghem Y. Incidence, determinants, and consequences of subclinical noncompliance with immunosuppressive therapy in renal transplant recipients. Transplantation. 1995 Feb 15;59(3):340-7.
Results Reference
background
PubMed Identifier
15307839
Citation
Vlaminck H, Maes B, Evers G, Verbeke G, Lerut E, Van Damme B, Vanrenterghem Y. Prospective study on late consequences of subclinical non-compliance with immunosuppressive therapy in renal transplant patients. Am J Transplant. 2004 Sep;4(9):1509-13. doi: 10.1111/j.1600-6143.2004.00537.x.
Results Reference
background
PubMed Identifier
17131276
Citation
Russell CL, Conn VS, Ashbaugh C, Madsen R, Hayes K, Ross G. Medication adherence patterns in adult renal transplant recipients. Res Nurs Health. 2006 Dec;29(6):521-32. doi: 10.1002/nur.20149.
Results Reference
background
PubMed Identifier
19386076
Citation
De Bleser L, Matteson M, Dobbels F, Russell C, De Geest S. Interventions to improve medication-adherence after transplantation: a systematic review. Transpl Int. 2009 Aug;22(8):780-97. doi: 10.1111/j.1432-2277.2009.00881.x. Epub 2009 Apr 6.
Results Reference
background
PubMed Identifier
21077956
Citation
Russell C, Conn V, Ashbaugh C, Madsen R, Wakefield M, Webb A, Coffey D, Peace L. Taking immunosuppressive medications effectively (TIMELink): a pilot randomized controlled trial in adult kidney transplant recipients. Clin Transplant. 2011 Nov-Dec;25(6):864-70. doi: 10.1111/j.1399-0012.2010.01358.x. Epub 2010 Nov 16.
Results Reference
background
PubMed Identifier
16162098
Citation
Denhaerynck K, Dobbels F, Cleemput I, Desmyttere A, Schafer-Keller P, Schaub S, De Geest S. Prevalence, consequences, and determinants of nonadherence in adult renal transplant patients: a literature review. Transpl Int. 2005 Oct;18(10):1121-33. doi: 10.1111/j.1432-2277.2005.00176.x.
Results Reference
background
PubMed Identifier
10665703
Citation
Mange KC, Cizman B, Joffe M, Feldman HI. Arterial hypertension and renal allograft survival. JAMA. 2000 Feb 2;283(5):633-8. doi: 10.1001/jama.283.5.633.
Results Reference
background
PubMed Identifier
36094829
Citation
Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
Results Reference
derived
PubMed Identifier
24004517
Citation
McGillicuddy JW, Gregoski MJ, Weiland AK, Rock RA, Brunner-Jackson BM, Patel SK, Thomas BS, Taber DJ, Chavin KD, Baliga PK, Treiber FA. Mobile Health Medication Adherence and Blood Pressure Control in Renal Transplant Recipients: A Proof-of-Concept Randomized Controlled Trial. JMIR Res Protoc. 2013 Sep 4;2(2):e32. doi: 10.2196/resprot.2633.
Results Reference
derived
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Adherence Enhancement for Renal Transplant Patients
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