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Table 4 Schema of patient-level data collection

From: Collaborative care for the detection and management of depression among adults with hypertension in South Africa: study protocol for the PRIME-SA randomised controlled trial

Outcome

 

Baseline

6 months

12 months

Outcome

Measurement

Source

Metric

   

Primary measurements

 Depression symptoms

PHQ-9

Self-reported

50% reduction in PHQ-9 score

a

b

Secondary mental health outcomes

 Depression symptoms

PHQ-9

Self- reported

50% reduction in PHQ-9 score

 Depression symptoms

PHQ-9

Self- reported

Remission defined as score of < 5 on PHQ-9

 Depression symptoms

PHQ-9

Self- reported

Mean PHQ-9 scores at 6 and 12 months

 Antidepressant treatment

 

Self- reported

Proportion with antidepressant treatment initiated or intensified

 Counselling

 

Self- reported

Proportion receiving counselling by clinic-based counsellor

 Referral to specialist mental health worker/service

 

Self- reported

Proportion referred

 Stress

Perceived Stress Scale

Self-reported

Mean score

 

Secondary hypertensive outcomes

 Blood pressure

 

Interviewer measured

Difference in means

 Retention in care

 

Self-reported; clinic records

Proportion in care

 

 Integrated care outcomes

 Cardiovascular risk factors

Blood pressure, weight, Body Mass Index, waist circumference

Interviewer measured

Difference in means

 Diagnosis of other co-morbid illnesses

 

Self-reported

Proportion diagnosed

  

 Quality of chronic illness care received

Patient Assessment of Care for Chronic Conditions (PACIC)

Self-reported

Mean PACIC score

 

 Health economic outcomes

 Health care utilisation

 

Self- reported; linkage with hospitalisation databases

Incidence rate ratio

 

 Productivity and economic outcomes

 

Self- reported

 

 

 Disability

WHO Disability Assessment Schedule 2.0

Self- reported

Mean score

 

 Safety measurements

Hospitalisation

 

Self- reported; linkage with hospitalisation databases

Proportion hospitalised

All-cause mortality

 

Clinic, report, linkage with mortality register

Proportion who died

Suicide

 

Follow-up of cause of all known deaths with clinic and family interview

Proportion of suicides

  1. a data measured
  2. b time when endpoint for outcome will be reported