Information technology in mental health

ISRCTN	ISRCTN74919979
DOI	https://doi.org/10.1186/ISRCTN74919979
Secondary identifying numbers	207384

Submission date: 07/12/2009
Registration date: 07/01/2010
Last edited: 11/09/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Maritta Välimäki
Scientific

Department of Nursing Science
Turku
20014
Finland

Phone	+358 (0)2 333 8495
Email	mava@utu.fi

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet (Finnish only)
Scientific title	Evaluation of internet-based patient support system in mental health care: a randomised controlled cost-effectiveness analysis
Study acronym	Mieli.Net
Study objectives	1. Does information technology (IT) affect patients' insight, quality of life, symptoms, compliance, knowledge of illness and its treatment, support treatment satisfaction, and independence or shore up opportunities for psychosocial functioning more effectively than written patient information or traditional information methods? 2. Does the use of IT in clinical practice improve the staffs' knowledge level and IT-related skills, attitudes towards technology use or affect staff co-operation and working methods? 3. What are the short and long-run costs of IT compared with written material and traditional methods used in clinical practice and does IT benefit the health care organisation and society more than the two other methods from the viewpoint of cost-effectiveness?
Ethics approval(s)	Ethics Committee of Pirkanmaa Hospital District approved on the 13th December 2004 (ref: ETL R01181)
Health condition(s) or problem(s) studied	Schizophrenia, schizotypal disorders or delusional disorders
Intervention	Staff in Group X will receive education (basic/advanced groups) on how to use computers, access internet-based services, and use IPSS during their educational sessions with patients. Only nurses in Group X have access to IPSS to avoid inter-group contamination. Staff in Group Y will be educated to manage education sessions with written/oral material only. In patient groups, Intervention Group A will receive need-based computerised information during discussions with a staff member with five technology sessions each lasting about 20 - 60 minutes roughly twice a week. At the end of the session, patients will receive individualised leaflets. They will also be instructed on how to use IPSS after discharge. Patients in Comparison Group B will have five oral sessions on their education programs (no use of IT). The content, number and length of the sessions is the same as in Group A. Patients in Control Group C will receive standard care, i.e. no educational sessions will be offered and they receive written information (e.g. leaflets) according to ward standards. Total duration of intervention was all together five education sessions after baseline measurement during one month and 1 - 2 sessions/week. Total duration of follow-up for all arms was 12 months.
Intervention type	Other
Primary outcome measure	Insight: The Schedule for the Assessment of Insight (SAI), measured at baseline (BL), 1, 3, 6 and 12 months
Secondary outcome measures	1. Quality of Life: Quality of life (the Quality of Well-Being, the Health Utilities Index, EQ-5D) and the Manchester Quality of Life Instrument (MANSA), measured at BL, 1, 3, 6 and 12 months 2. Symptoms: Semi-structured interview addressing psychiatric symptoms (Positive and Negative Syndrome Scale [PANNS]), measured at BL, 1, 3, 6 and 12 months 3. Compliance: Patients' compliance with treatment, patients' compliance with medication (Drug Attitude Inventory [DAI]), measured at BL, 1, 3, 6 and 12 months 4. Follow-up of medication adherence and treatment appointments (analysis of medical records) 5. Knowledge about illness and treatment: Knowledge test, measured at BL, 1, 3, 6 and 12 months 6. Treatment satisfaction during discharge process (Client Satisfaction Questionnaire-8 [CSQ-8]), measured at BL and before discharge 7. Disability and psychosocial functioning: symptoms disturbing work, social life, and family responsibilities (Sheehan Disability Scale) and the Global Assessment of Functional Scale (GAF), measured at BL, 1, 3, 6 and 12 months In addition, drop-outs in each arm were analysed to estimate the acceptance of the interventions.
Overall study start date	14/03/2005
Completion date	04/10/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	300
Key inclusion criteria	1. Aged 18 - 65 years, either sex 2. Diagnosis of schizophrenia, schizotypal disorders or delusional disorders (chapters F20 - F29, International Classification of Disease, version 10 [ICD-10])
Key exclusion criteria	1. Unable to use the Finnish language 2. Unable to give written informed consent to participate
Date of first enrolment	14/03/2005
Date of final enrolment	04/10/2007

Locations

Countries of recruitment

Finland

Study participating centre

Department of Nursing Science

Turku
20014
Finland

Sponsor information

Academy of Finland (Finland)
Government

Vilhonvuorenkatu 6
PL 99
Helsinki
00501
Finland

Website	http://www.aka.fi/en-gb/A/
"ROR"	https://ror.org/05k73zm37

Funders

Funder type

Government

The Academy of Finland (Finland) (ref: 207384)

No information available

The Jalmari and Rauha Ahokas Foundation (Finland)

No information available

The Finnish Cultural Foundation Uusimaa Regional Fund (Finland)

No information available

The Hospital District of Helsinki and Uusimaa (Finland)

No information available

The Pirkanmaa Hospital District (Finland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2012		Yes	No