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Table 2 Summary table of data collection in COPSI.

From: Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial

TYPE OF DATA
1. Quantitative: (using a combination of programmed palmtops and paper and pencil methods)    Measured at:
Primary Outcome Interviewee Outcome assessment scale description 0 month 6 months 12 months
Symptoms Person with schizophrenia Positive and Negative Syndrome Scale (PANSS). The PANSS has 30 items to record current psychopathology on 3 domains- positive symptoms, negative symptoms and general psychopathology; each item rated on 1-7 scale thus having a total score range of 30-210. X   X
Disability Primary caregivers Indian Disability Evaluation and Assessment Scale (IDEAS). For the IDEAS evaluation, the participant is assessed on 4 domains- Self Care, Interpersonal Activities, Communication and Understanding and Work. The scale generates a global score of 0-20 with increasing scores indicating more severe disabilities X X X
Secondary outcomes
Stigma and discrimination Person with schizophrenia Discrimination and Stigma Scale (DISC). The version to be used is based on DISC-12, but was adapted for the study. The revised version has 30 items in total, all rated on a 4 point Likert scale ranging from 'not at all' to 'a lot'. X   X
   There are 20 items in the Negative Discrimination Subscale plus 1 new negative discrimination item generated for the trial, 4 items on anticipated discrimination, 1 item relating to efforts of overcoming stigma and discrimination and 4 items for recording experiences of positive discrimination.    
Internalized stigma   The Internalized Stigma of Mental Illness (ISMI) scale is designed to measure the subjective experience of internalized stigma and consists of 5 subscales. For the study, the 'Alienation' subscale was chosen. It consists of 6 items which are scored on a 4-point Likert scale ranging from 'strongly disagree' to 'strongly agree'. X   X
Willingness to disclose illness   An item on willingness to disclose mental illness rated on a 5-point Likert scale ranging from 'very uncomfortable' to 'very comfortable'. X   X
Quality of life   Euroqol EQ-5D that has a descriptive assessment of 5 domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each domain is coded as level 1, 2 or 3 and combined into a 5 digit code together with a summary visual analogue scale assessment of quality of life score 0-100. X   X
Subjective rating of adherence with antipsychotic medication   Adherence rating tool with 5 ordinal ratings to describe a range of adherence (from non adherent- fully adherent) X X X
Knowledge of and attitudes towards illness Primary caregiver(s) Knowledge about Schizophrenia Interview (KASI). There are 6 domains of understanding that are assessed; the maximum score for each domain being 4. X   X
The family burden of caring   The Burden Assessment Schedule (BAS). The BAS is scored on 40 items with a maximum score of 120; the minimum score can be less than 40 as some questions can be rated as 'not applicable'. X   X
Costs of illness   Cost of Illness Schedule (CIS) X X X
Adherence with antipsychotic medication   Adherence rating tool with 5 ordinal ratings ranging from non- adherent to fully adherent supplemented by audit of actual medicine use over last 2 months that is extrapolated to the previous 6 month period X X X
Experiences of stigma and discrimination   14 items from the Stigma section of the Family Interview Schedule (FIS) will be used to assess the experiences of stigma the primary caregivers. These cover several aspects of internalized stigma as well including perceived need to conceal the illness and anticipated discrimination. The items are scored on a 4-point Likert scale (0 - 3) ranging from 'not at all' to 'a lot'. X   X
Willingness to disclose   Item on willingness to disclose mental illness rated on a 5-point Likert scale ranging from 'very uncomfortable' to 'very comfortable'. X   X
2. Clinical outcomes of interest: Information source How recorded? Frequency of measurement
Treating Psychiatrist's assessment of overall clinical change Clinical records maintained by treating Psychiatrist Clinical Global Impression-Schizophrenia 'overall change' scale section Every 3 months
Treating Psychiatrist's assessment of adherence   5 point nominal measure, similar to that used by participants and caregivers Every 3 months
Inpatient stay details   Recorded for each such episode by treating Psychiatrist Collated at endpoint
Relapse of illness   Relapse is defined as clinically significant exacerbations of symptoms after at least 2 months of well- being; clinical significance involves meeting at least 2 of the following 3 criteria: marked increase in positive symptoms, hospitalization for acute care and significant increase in dosage of antipsychotic medications Collated at endpoint
Serious antipsychotic medication side effects As above; also during by 6 and 12 month outcome assessments.   Collated at endpoint
3. Process indicators    
A. For participants in both arms of study Clinical records maintained by treating Psychiatrist Number of contacts with treating Psychiatrists Type (face to face or telephone) contacts Treatment details- use of psychotropic medications and Electro Convulsive Treatments    
B. For participants in the CCBC arm Individual care plan records maintained by the Community Health Workers' (CHW's) The delivery of the components of the intervention as per protocol over the 3 phases of the intervention Collated at endpoint
   Per protocol supervision for CHW's Every 3 months
   Total number of contact by the CHW's during the 12 month period of the intervention Every 3 months