Table-I.
Schedule of enrollment, intervention and assessment of recruited participants according to SPIRIT 2013
| Study Period (In weeks) | |||||
|---|---|---|---|---|---|
| Enrolment | Baseline | Allocation | Post-allocation | ||
| TIMEPOINT | 1-2 | 12 | 24 | ||
| ENROLMENT: | |||||
| Eligibility screen | X | ||||
| Informed consent | X | ||||
| Empowering with Self-monitoring devices & brochure to fill | X | ||||
| Allocation | X | ||||
| INTERVENTIONS: | |||||
| [Group A] | ⟷ | ||||
| [Group B] | ⟷ | ||||
| ASSESSMENTS: | |||||
| Basic Demographic Variables | X | ||||
| HRQoL (MacNew QMLI & SF-12) | X | X | X | ||
| Clinical Outcomes | X | X | X | ||
| Behavioural Outcomes | X | X | X | ||
| Adherence | X | ||||