Table 1.
Timepoint | Study period | ||||
Preallocation | Postallocation | Close-out | |||
Enrolment | Baseline | 6 months | 12 months | 18 months | |
Eligibility screen | X | ||||
Informed consent | X | ||||
Interventions | |||||
VCoP | |||||
Usual care | |||||
Assessments | |||||
PAM | X | X | X | X | |
Sociodemographic and clinical variables | X | X* | X* | X* | |
Knowledge | X | X | X | X | |
SMCDS | X | X | X | X | |
Mediterranean Diet Questionnaire | X | X | X | X | |
IPAQ | X | X | X | X | |
PHQ-9 | X | X | X | X | |
HADS-A | X | X | X | X | |
ARMS-e | X | X | X | X | |
EQ-5D-5L | X | X | X | X | |
Use of resources | X | X | X | ||
Use of VCoP | |||||
Adverse events |
*Follow-up of just clinical variables.
ARMS-e, Adherence Refill and Medication Scale; HADS, Hospital Anxiety and Depression Scale; IPAQ, International Physical Activity Questionnaire; PAM, Patient Activation Measure; PHQ-9, Patient Health Questionnaire; SMCDS, Self-efficacy Managing Chronic Disease Scale; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; VCoP, Virtual Community of Practice.