Smart Phone Medication Adherence Saves Kidneys--SMASK

Investigators will employ a 2-arm Randomized Controlled Trial (RCT) design with the subject as the unit of randomization and analysis. Kidney transplant recipients having uncontrolled hypertension will be enrolled into a screening phase to measure medication non-adherence. Each subject will use an electronic pill tray for 1 month without any reminder functions activated. Non-adherent subjects who remain uncontrolled will be randomly assigned to SMASK or Standard Care (SC). SC will continue to use the pill tray with reminders turned off and will receive attention control texts with healthy lifestyle information. SMASK will have the reminder functions of the electronic pill tray activated and will receive a Bluetooth blood pressure monitor and an app to collect the data and send to researchers.

Subjects in the second phase will participate in 4 more evaluations at months 1, 3, 6, 12 post randomization. Research staff will measure resting blood pressure and heart rate.

Study Overview

• Status: Completed
• Conditions: Hypertension; Medication Adherence; Kidney Transplantation
• Intervention / Treatment: Behavioral: SMASK; Behavioral: EnhancedSC

Detailed Description

A randomized RCT will be conducted with kidney transplant patients identified as hypertensive (>129 SBP following KDIGO guidelines) via medical history. Those identified as being nonadherent for 4 weeks during the first month post enrollment (adherence score <0.85) will be eligible to participate in the second phase. Participants in the second phase will be randomly assigned to standard care (SC) + attention control or the mHealth program plus SC.

Following informed written consent, eligible patients will be asked to complete several brief surveys aimed at determining, mood state, perceived stress, self-efficacy assessment, comfort with mHealth devices, perceptions of treatment burden and attitudes towards mhealth. Subjects will have their blood pressure measured and if SBP is >129 they will enter the screening phase. Subjects will be provided a Medication dispensing device system. Subjects will be called the following day to check if there were any problems in filling the Simplemed tray.

The Simplemed has four compartments for each day of the week for potential use. Microelectronic circuitry in each compartment on the tray date stamps the opening of each compartment and removal of the refill tray. These signals are relayed via an internal modem to a server for processing. Data can then be sent directly into the MUSC server that compiles individuals' health data from multiple delivery points. Adherence rate across the first month will be calculated at weekly intervals.

All subjects will return for a visit at the end of their 4 week screening period. Those with an adherence score <0.85 for 4 weeks and whose SBP continues to be >129 will be invited to participate in the second phase of the RCT. Evaluations performed at this visit will include anthropometrics, questionnaires, and resting BP. A Spacelabs ABP monitor will be applied with instructions for wearing the monitor 24 hrs. The subjects will be randomized to SMASK+SC or SC+ attention control groups after the baseline procedures are completed. Those with med adherence score ≥0.85 or who have SBP ≤ 129 will return their pill tray but not proceed into the second phase. Recruitment will end when 80 subjects have successfully transitioned into the second phase (RCT) of the study.

The SC+ attention control group will continue to use Simplemed with reminder functions disabled, they will be sent daily text messages or links to PDF documents or videos containing health information as attention control. The SMASK mhealth intervention group will also receive SC and have the Simplemed reminder functions turned on (blink for ½ hr when medication is due, chime additional ½ hr, then text or email after 1 hour) and receive training in use of the A&D BP monitor. They will be instructed to measure their blood pressure twice daily AM, PM) on at least every third day. Patients will be provided with and shown how to use the smart phone app and activate the app when they record their blood pressure readings.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ≥21 years old;
2. First time recipient of a functioning solitary kidney transplant;
3. Prescribed ≥3 medications for immunosuppression and HTN;
4. Transplant MD's assent that patient is able to participate;
5. Ability to speak, hear and understand English;
6. Able to take their own BP;
7. Self-administers medications;
8. SBP >129 mmHg at clinic visit(s) in 4 weeks prior, and at initial study evaluation at enrollment;
9. ***Only subjects with adherence score <.85 after 1-month screening and SBP >129 mmHg at baseline will be randomized.

Exclusion Criteria:

1. Failure to meet any inclusion criterion;
2. Ongoing substance abuse (e.g., >21 alcoholic drinks/week);
3. Psychiatric illness requiring treatment beyond antidepressants;
4. Will attempt to become pregnant within the year;
5. Pregnant or nursing women, prisoners, and institutionalized persons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SMASK; Subjects will receive electronic pill tray with reminder functions activated and Bluetooth blood pressure monitor and phone app.	Behavioral: SMASK; Medication adherence and BP monitoring
Other: EnhancedSC; Subjects will receive daily attention control texts with healthy lifestyle information and continue to use the pill tray without reminder functions.	Behavioral: EnhancedSC; Standard care without med reminder functions with healthy lifestyle texts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence	% with electronic monitor-derived adherence scores >.90;	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider adherence to KDIGO guidelines	measured by timing of medication changes	six months
Changes in Self-Determination Theory mediators	Survey responses demonstrate increased (e.g., perceived competence and autonomous regulation).	six months
BP control	% reaching and sustaining Kidney Disease Improving Global Outcomes (KDIGO) guidelines for BP control (resting and 24-hr BP<130/80 mmHg).	Six months

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: John McGillicuddy, MD, MUSC Transplant Surgery

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: Pro00053471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO