The feasibility of using electronic clinical outcome assessments in people with schizophrenia and their informal caregivers

Figures & data

Table 1 Study recruitment strategy

Study inclusion criteria
People with schizophrenia	• A medically confirmed diagnosis of schizophrenia according to DSM-IV-TR classification criteria • Currently taking an atypical or typical antipsychotic • Aged ≥18 years • In good general health aside from their schizophrenia
Caregivers	• Identified as the primary informal caregiver of a person with schizophrenia (as reported by both the person with schizophrenia and the caregiver themselves) • Provides care to the person with schizophrenia for at least 4 hours per week • Aged ≥18 years
Support staff members	• Identified as the person at the site who would typically be responsible for administering questionnaires to patients
Recruitment quotas and justification
DSM-IV-TR schizophrenia subtype	Previous research implied that behaviors associated with certain subtypes of schizophrenia may have differential effects on the ability to complete instruments on an eCOA device.^Citation10,Citation26 Efforts, therefore, were made to recruit a sample representative of different DSM-IV-TR subtypes and varying manifestations of positive and negative symptoms associated with schizophrenia
Schizophrenia severity	Efforts were made to recruit participants of varying severities of schizophrenia. A CGI-S scale was completed by recruiting physicians as a means of assessing symptom severity. Representation of people with schizophrenia with CGI scores from 3 (mildly ill) to 6 (severely ill) was targeted. Note: people with a CGI score of 7 (among the most extremely ill patients) were judged by the recruiting physicians as unsuitable for participation in this study due to their symptomology and the fact that they would likely be receiving formal or paid care
Caregiver age	A quota was implemented to recruit a representative sample of caregivers both over and under 60 years of age.
Caregiver education	It was ensured that at least 20% of the caregivers had high school as their highest level of education

Abbreviations: CGI, Clinical Global Impression; CGI-S, Clinical Global Impression of Severity; DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; DSM-IV-TR, DSM-IV Text Revision; eCOA, electronic clinical outcome assessment.

Table 2 Demographic and clinical characteristics

Demographic characteristic	Person with schizophrenia	Caregiver	Research support staff member
Age (years)
Mean	47	57	44
Range	23–83	24–70	25–69
Sex, n (%)
Male	6 (50)	3 (25)	0
Female	6 (50)	9 (75)	6 (100)
Work status, n (%)
Working full or part time	4 (33)	6 (50)	6 (100)
Looking for work	1 (8)	0	0
Full-time homemaker	1 (8)	0	0
College or university student	0	0	0
Not working due to schizophrenia diagnosis	5 (42)	2 (17)	0
Retired	1 (8)	4 (33)	0
Other	0	0	0
Race, n (%)
Black/African American	9 (75)	9 (75)	5 (83)
White/Caucasian	3 (25)	3 (25)	1 (17)
Years since diagnosis, n (%)
0–10	5 (42)	N/A	N/A
11–20	2 (17)
20+	5 (42)
Range	2–33
Mean	14.8
Schizophrenia DSM-IV-TR subtype, n (%)
Paranoid	5 (42)	N/A	N/A
Disorganized	3 (25)
Undifferentiated	3 (25)
Paranoid, disorganized	1 (8)
Schizophrenia severity, n (%)
CGI-S score 3	4 (33)	N/A	N/A
CGI-S score 4	4 (33)
CGI-S score 5	3 (25)
CGI-S score 6	1 (8)
Medication, n (%)
Typical antipsychotic	2 (17)	N/A	N/A
Atypical antipsychotic	9 (75)
Antidepressant	6 (50)
Anti-anxiety	3 (25)
Other	3 (25)
Education, n (%)
High school diploma or GED	N/A	5 (42)	0
Some years of college		3 (25)	3 (50)
Certificate program		0	2 (33)
College or university degree (2- or 4-year)		3 (25)	0
Graduate or professional degree		1 (8)	1 (17)
Living with person with schizophrenia, n (%)
Yes	N/A	10 (83)	N/A
No		2 (7)
Relationship with person with schizophrenia, n (%)
Parent	N/A	4 (33)	N/A
Partner/spouse		2 (17)
Sibling		2 (17)
Son/daughter		2 (17)
Friend		1 (8)
Grandparent		1 (8)
Years spent caring for person with schizophrenia, n (%)
0–10	N/A	8 (67)	N/A
11–20		1 (8)
20+		3 (25)
Range		3–41
Mean		14
Hours per week spent caring for person with schizophrenia, n (%)
<20	N/A	5 (42)	N/A
21–40		3 (25)
40+		4 (33)
Range		5–40+
Mean		47
Years in current job
0–5	N/A	N/A	4 (67)
6–10			1 (17)
11–15			0
15+			1 (17)

Abbreviations: CGI-S, Clinical Global Impression of Severity; DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; DSM-IV-TR, DSM-IV Text Revision; N/A, not applicable or not asked of that population; GED, General Educational Development.

Table 3 Participant comments on electronic clinical outcome assessment completion

Participant quotes
General thoughts	Person with schizophrenia • “It was easy. Um, it was easy. It was very simple.” (BM-P1-F-40-R) • “Because all you had to do was read it – read it and tap – and tap it at the bottom.” (NO-P3-M-42-P) • “I just think it was easier than dealing with a pen and paper … It was pretty simple and straightforward.” (SL-P5-M-47-U)
	Caregiver • “It’s very easy to use. It’s fast.” (NO-C2-F-57) • “The questions were clear and the answers were clear. And you just press the one that you want to.” (SL-C1-F-70)
	Staff member • “I think it was very easy – to maneuver through, very self-explanatory.” (BM-S2-F-35) • “It’s more clear-cut and simple.” (SL-S1-F-42)
Appearance and size	Person with schizophrenia • “Absolutely perfect. The writing is bold. Um, I put my glasses on, but I would’ve probably not really needed – you know, to have them on. The size of the letters and stuff like that. It just things was – it was just perfect.” (BM-P3-F-55-R) • “It’s a little big. I mean, you’re just answering questions on it. Uh, it doesn’t have to be that big.” “It could be smaller, though, because it would be easier to hold in your hand and what have you.” (BM-P1-F-40-R)
	Caregiver • “The screen is perfect. The size is really good.” (SL-C4-F-46) • “I – what I don’t like about it is like I wanted to kind of put it down when I did it, you know, like that … It’s so heavy.” (SL-C1-F-70). • “I would change the outer case and probably make it thinner.” (NO-C5-M-57)
	Staff member • “And it’s, uh, reliable – and durable. And I think that would be the most important parts.” (NO-S1-F-59) • “I think it’s a little big. Um, it could be smaller. Um – And it’s a – it’s a – the weight is a little heavy.” (NO-S3-F-35)
Touchscreen	Person with schizophrenia • “Because I just had to tap. I didn’t have to write.” (NO-P1-F-42-P)
	Caregiver • “Moving on to the next thing took maybe a little longer than I’m used to, but it wasn’t an impediment at all.” (SL-C3-F-69).
	Staff member • “And you don’t have to keep pressing it or maybe even put in a – trying to pluck it out – to – it’s just touch screen is just easier.” (NO-S1-F-59)
Question layout	Person with schizophrenia • “They were good. It was set up well.” “Q: The layout of it?” “Yeah, the layout. It was good, it was simple.” (BM-P2-F-53-R)
	Caregiver • “I thought the questions were very good and I thought they were worded good and the layout was very well – where you could just read it and it wasn’t hard to understand, because it’s pretty straightforward.” (SL-C4-F-46). • “And that top part, every time I went to – a question, that top part came back up. So why continue to, uh, include that? You know, I mean, let it be one time and just move on to the questions.” (NO-C4-F-63).
	Staff member • “It’s very clear. Very clear. If you read, uh, you know, the questions, they got straight to the point.” (NO-S2-F-25)
Text size	Person with schizophrenia • “It was an easily readable font.” (SL-P5-M-47-U) • “Well, or not necessarily make the text bigger or maybe give you an option that would allow – like if you realized that you couldn’t read it very well because the text was smaller maybe something that would enlarge it that way.” (SL-P5-M-47-U)
	Caregiver • “The size of the type and the, um the spacing … I thought it was clear.” (SL-C3-F-69)
	Staff member • “Um, it wasn’t too big. It wasn’t too bright.” (BM-S2-F-35) • “We had some elderly people, and, uh – would be easier – I changed the fonts – be able to change the font size. That’s the only thing, so.” (BM-S1-F-69)
Completion time	Person with schizophrenia • “It was pretty fast. It didn’t take a lot of time at all actually.” (SL-P1-M-31-P)
	Caregiver • “It didn’t take long at all. Before I knew it, I was at the end.” (SL-C4-F-46)
	Staff member • “Actually, I thought it was pretty fast. I thought they answered it, uh, pretty quickly.” (NO-S2-F-25) • “And a lot of times it depends on the patient. If the patient understands and how fast or slow they read.” (NO-S3-F-35)
Ability to go back	Person with schizophrenia • “I thought about it. I – I thought that maybe in a couple I should have – um, I didn’t – I didn’t answer, like, 100% truthfully, but – Not – not that it wasn’t 100% truthfully. It’s – just say I can’t – I couldn’t make up my mind on the answer.” (BM-P1-F-40-R)
	Caregiver • “I just wanted to check and make sure, like, it was accurate.” (NO-C2-F-57)
Number of items per screen	Person with schizophrenia • “See, sometimes things get complicated. That confuse somebody, or they get anxiety when they see all these questions on paper. Oh Lord, this is a test! You know? But here – I was in a good mode doing what I was doing when I focus.” (BM-P2-F-53-R) • “And I liked the way that it was one question per page, not a whole looming page of questions that makes it look much more intimidating.” (SL-P5-M-47-U)
	Caregiver • “You can focus on this one question – without drifting – on the other questions.” (NO-C5-M-57)
Moving to next questionnaire	Person with schizophrenia • “Maybe the first one should have been highlighted or had a check box next to it so you knew you always – you had already done that. Because whenever we got to – through like the third questionnaire and there was the fourth one there – I kind of paused going, OK, which one did I just come out of?” (SL-P5-M-47-U)
	Staff member • “He knew to go to the next one. So I didn’t even have to tell him to go.” (NO-S1-F-59) • “Yeah. I – I think probably it could have just simply said, eh, the word completed … And just say – and the next screen – and to complete it, tap. And then the next section could have said, start next section.” (BM-S1-F-69)
Repeated completion over 3 months	Person with schizophrenia • “ I think, if I knew that I was answering it on the same type of device I think I would probably agree to it faster than I would if it was paper and pencil.” (SL-P5-M-47-U)
	Caregiver • “That would be fine. It’s – it’s really quick and – easy, like – and I mean, like I said, for the amount of information I filled it out – filled out – it wasn’t – the timing wasn’t bad.” (BM-C2-F-24)
Assisting completion	Staff member • “The questions for the schizophrenia patients, um, were a little – a little bit easier than the caregiver questions. They were more easy for them to read, and it was a – a lot shorter, straight to the point questions. They were – to which the caregiver questions were a little more in – in dep – in detail.” (NO-S3-F-35) • “Yes. Yeah, because he – he caught on fast.” (NO-S1-F-59)

Notes: Subject IDs are provided in parenthesis after quotes. IDs refer to site, subject type, gender, age and DSM-IV-TR subtype.

Abbreviation: DSM-IV-TR, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.

GranholmELohCSwendsenJFeasibility and validity of computerized ecological momentary assessment in schizophreniaSchizophr Bull20083450751417932087

 PubMed Web of Science ®Google Scholar

ChinmanMYoungASSchellTHassellJMintzJComputer-assisted self-assessment in persons with severe mental illnessJ Clin Psychiatry2004651343135115491237

 PubMed Web of Science ®Google Scholar