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Table 1 Overview of objectives and measures at different time-points

From: Comparison of a home-based (multi) systemic intervention to promoting Medication AdheRence and Self-management among kidney transplant recipients with care-as-usual: the MARS randomized controlled trial protocol

Objectives Measures T0 T1 T2 T3
Primary objective
 To test the effectiveness of the MARS- intervention (experimental group) in promoting medication adherence as measured by Electronic Monitoring in comparison to CAU (control group). Data from Electronic Monitoring   X X X
Secondary objectives patient
 To test the effectiveness of the MARS-intervention in promoting the medication adherence as measured by secondary outcome measures in comparison to CAU (control group).
 To test whether the effectiveness of the MARS-intervention on medication adherence sustains after six months (T2-T3).
 To asses when the MARS-intervention influences medication adherence the most.
Questionnaires patient     
Medication adherence (BAASIS) X X X X
Medical data patient file     
Intra patient variability (IPV) X X X X
Rejection of the graft (treatment for rejection)    X X
Graft loss    X X
Kidney functioning (eGFR) X X X X
Collateral report social network     
Medication adherence (BAASIS) X X X X
Collateral report Health Care Professional     
Adherent to medication (Y/N) X X X X
 To test the effectiveness of the MARS-intervention (experimental group) in promoting self-management in comparison to CAU (control group). Questionnaires patient     
Self-management skills (PiH-NL) X X X X
Medical data patient file     
Blood pressure X X X X
Weight X X X X
 To test the effectiveness of the MARS-intervention (experimental group) in promoting self-efficacy in comparison to CAU (control group). Questionnaires patient     
Self-efficacy (GSE) X X X X
 To test the effectiveness of the MARS-intervention (experimental group) in promoting mental health in comparison to CAU (control group). Questionnaires patient     
Quality of life (WHOQoL-Bref) X X X X
Depression & Anxiety (HADS) X X X X
Positive & Negative affect (PANAS) X X X X
 To test the effectiveness of the MARS-intervention (experimental group) in promoting social support in comparison to CAU (control group). Questionnaires patient     
Social support (MOS-SSS) X X X X
(heiQ- subscale Social Integration and Support) X X X X
(Self-developed item on who provides support in general and in relation to medication) X X X X
Secondary objectives important other from the social network
 To test the effectiveness of the MARS-intervention (experimental group) in promoting mental health among an important other in the social network of the patient in comparison to CAU (control group). Questionnaires important other     
Quality of life (CarerQol-7D)   X X X
Depression (PHQ-9)   X X X
Anxiety (GAD-7)   X X X
Positive & Negative affect (PANAS)   X X X
 To test the effectiveness of the MARS-intervention (experimental group) in promoting social support among an important other in the social network of the patient in comparison to CAU (control group). Questionnaires important other     
Social support (MOS-SSS)   X X X
(heiQ- subscale Social Integration and Support)   X X X
(self-developed item on who provides support)   X X X