NCT02827695

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

4 years

First QC Date

July 6, 2016

Last Update Submit

October 20, 2020

Conditions

Kidney TransplantationMedication AdherenceHypertension

Outcome Measures

Primary Outcomes (1)

  • Medication Adherence

    % with electronic monitor-derived adherence scores \>.90;

    six months

Secondary Outcomes (3)

  • Provider adherence to KDIGO guidelines

    six months

  • Changes in Self-Determination Theory mediators

    six months

  • BP control

    Six months

Study Arms (2)

SMASK

EXPERIMENTAL

Subjects will receive electronic pill tray with reminder functions activated and Bluetooth blood pressure monitor and phone app.

Behavioral: SMASK

EnhancedSC

OTHER

Subjects will receive daily attention control texts with healthy lifestyle information and continue to use the pill tray without reminder functions.

Behavioral: EnhancedSC

Interventions

SMASKBEHAVIORAL

Medication adherence and BP monitoring

SMASK
EnhancedSCBEHAVIORAL

Standard care without med reminder functions with healthy lifestyle texts

EnhancedSC

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Ongoing substance abuse (e.g., \>21 alcoholic drinks/week);
  • Psychiatric illness requiring treatment beyond antidepressants;
  • Will attempt to become pregnant within the year;
  • Pregnant or nursing women, prisoners, and institutionalized persons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • 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.

    PMID: 36094829DERIVED

MeSH Terms

Conditions

Medication AdherenceHypertension

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorVascular DiseasesCardiovascular Diseases

Study Officials

  • John McGillicuddy, MD

    MUSC Transplant Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 11, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2020

Study Completion

August 31, 2020

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)