Table 2 Summary of outcomes measures for the Task Sharing for the Care of Severe Mental Disorders in a Low-income Country (TaSCS) trial
| Â | Outcome | Measure | Timing |
|---|---|---|---|
Primary outcome | |||
1 | SMD symptom severity | BPRS-E | Baseline, 12* and 18Â months |
Secondary outcomes | |||
1. | Functional impairment± | WHODAS 2.0 (12-item) | Baseline, 12 and 18 months |
Local functioning scale | Baseline, 12 and 18Â months | ||
2. | Relapse of mental disorder | LCS | Baseline, 12 and 18Â months |
3. | Service use costs | CSRI | Baseline, 12 and 18Â months |
4. | Satisfaction with mental health care | Mental health service satisfaction scale (MHSSS) | Baseline, 12 and 18Â months |
Qualitative in-depth interviews | From 6Â months post-randomisation | ||
5. | Nutritional status | Body Mass Index | Baseline, 12 and 18Â months |
6. | Service use for physical health conditions | CSRI | Baseline, 12 and 18Â months |
7. | Medication side effects | ASC | Baseline, 12 and 18Â months |
8 | Patient engagement and adherence | Medication Adherence Measure Clinic attendance | Baseline, 12 and 18Â months |
9. | Perceived stigma | ISMI | Baseline, 12 and 18Â months |
10. | Restraint± | Proportion chained, restrained or confined in last month | Baseline, 12 and 18 months |
11. | Quality of care | Document review | Monthly for 3Â months, 6, 12 and 18Â months |
13. | Adverse events (AEs) | LCS and project reporting mechanisms for AEs | Continuous for serious AEs 6-monthly for other AEs |
Mediating variable | |||
1. | Therapeutic alliance | HAQ | Baseline, 12 and 18Â months |
Caregiver outcomes | |||
1. | Perceived stigma | FIS | Baseline, 12 and 18Â months |
2. | Caregiver burden | FIS | Baseline, 12 and 18Â months |
3. | Time burden of caring and opportunity costs | CSRI | Baseline, 12 and 18Â months |
Potential confounding variables | |||
1. | Sociodemographic characteristics | Structured self-report of age, sex and marital status | Baseline |
2. | Socio-economic status | Structured self-report of educational level, occupational status, food insecurity and family size | Baseline |
3. | Alcohol use disorder | FAST | Baseline |
4. | Khat use disorder | CIDI substance use module | Baseline |
5. | Medical co-morbidity or physical disability | Structured self-report | Baseline |