NCT06106854

Brief Summary

The SystemCHANGETM intervention harnesses patients' established daily routines/habits, environment, and important others, as possible solutions that are reoccurring and thus reliable systems that could support medication taking to become a dependable routine/habit. The aim of this study was to evaluate the effect of a six-month SystemCHANGE™ intervention compared to a six-month attention-control education intervention on medication adherence in adult kidney transplant recipients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration 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

September 16, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 29, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
Last Updated

October 30, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

September 29, 2023

Last Update Submit

October 24, 2023

Conditions

Medication Adherence

Keywords

medication adherenceimmunosuppressive medicationsadult kidney transplant recipientsnursingSystemCHANGE

Outcome Measures

Primary Outcomes (1)

  • medication adherence

    The six-month maintenance phase followed the intervention phase. In this phase, the patients continued to use the electronic medication monitoring cap and bottle. They were not contacted by the researcher until the completion of the six-month maintenance phase when they were contacted to return their electronic medication monitoring cap and Medication Event Monitoring System (MEMS) diary.

    12-months

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Behavioral: SystemCHANGE

Control

PLACEBO COMPARATOR
Other: Education

Interventions

Behavioral: SystemCHANGEBEHAVIORAL

six-month SystemCHANGE™ intervention

Intervention
EducationOTHER

Six patient education booklets

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yaprak Sarıgöl Ordin

Izmir, 35240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Medication Adherence

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Doctor

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 30, 2023

Study Start

September 16, 2019

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

October 30, 2023

Record last verified: 2023-09

Locations

TU(1)