Table 1.
List of measures and evaluation time points.
| Outcome variables | Measurements/instruments used | Screening | Baseline | 1 month | 3 months | 6 months | 12 months | |
| Primary outcomes | ||||||||
|
|
Medication adherence | Vaica (time-stamped) | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|
|
BPa | Clinic resting SBPb | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Secondary outcomes | ||||||||
|
|
Therapeutic Inertia | Provider adherence to KDIGOc goals: Timely medication changes (date of medication change following medication adherence) and BP feedback (biweekly SMASKd reports for SMASK participants) and from clinic visits for all subjects (Figure 2) | Weeklye | Weeklye | Weeklye | Weeklye | Weeklye | Weeklye |
|
|
Self Determination Theory Constructs | TSRQf autonomous self-regulation [51,52] (α=0.81-0.84; correlation with GCOSg: r=0.38, P<.001; correlation with HCCQh: r=0.38, P<.001), weight loss attendance (r=0.34, P<.001), body mass index (r=-0.11, P<.05), 18-month test-retest autonomous (r=0.47), controlled items (rs=0.34]) [53], correlation with medication adherence (r=0.58, P<.001)] [54] | ✓ |
|
|
✓ | ✓ | ✓ |
| Exploratory outcomes | ||||||||
|
|
eGFRi | GFRj estimation equations [55,56] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|
Ambulatory BP | 24-h ambulatory BP with SpaceLabs 90207 |
|
✓ |
|
|
✓ | ✓ |
|
|
Methodological parameters | |||||||
|
|
|
Recruitment and retention rates: patient/provider satisfaction and usefulness scale (TSUQk) [57] (satisfaction: α=0.96; usefulness: α=0.92; 1-week test-retest r=0.98 [58]) |
|
|
|
|
✓ |
|
|
|
Fidelity checklists: patient level (eg, connection/reloads of Vaica, BP uploads via phone, and opening of messages/education information) and provider level (eg, opening of patient summary reports and phone alerts) |
|
|
|
|
|
|
|
|
|
Ancillary medication adherence measures | Medication possession rate | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Potential moderators/mediators | ||||||||
|
|
Demographics | Age, education level, income, type of health care insurance | ✓ |
|
✓ | ✓ | ✓ | ✓ |
|
|
Anthropometrics | Height, weight, girth | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|
Health literacy | Health Literacy Scale [59-62], correlated with short test of functional health literacy in adults. Three questions compared to those in the Short Test of Functional Health Literacy in Adults to detect inadequate health literacy: areas under the receiver operating characteristic curve were 0.76, 0.80, and 0.87. When correlated with Short Form-36 (r=0.86-0.87), it differentiates between healthy status and various types of illnesses (eg, migraine vs healthy using components: physical and mental quality of life; all P<.001) |
✓ |
|
|
|
|
|
| Adverse events | ||||||||
|
|
Medication Side Effects Scale [63,64] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
|
|
Hypertension/immunosuppression knowledge [59,65] (α=0.70, high-low correlation: P<.01) | ✓ |
|
|
|
|
|
|
|
|
Short Form-8 (α=0.87) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
|
|
Perceived Stress Scale (α=0.84-0.86; 2-day test-retest r=0.85) [64] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
aBP: blood pressure.
bSBP: systolic blood pressure.
cKDIGO: Kidney Disease Improving Global Outcomes.
dSMASK: Smartphone Medication Adherence Saves Kidneys.
eWeekly SMASK reports and from clinic visits for all subjects.
fTSRQ: Treatment Self-Regulation Questionnaire.
gGCOS: General Causality Orientations Scale.
hHCCQ: Health Care Communication Questionnaire.
ieGFR: estimated glomerular filtration rate.
jGFR: glomerular filtration rate.
kTSUQ: Telemedicine Satisfaction and Usefulness Questionnaire.