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Information technology in mental health
ISRCTN ISRCTN74919979
DOI 10.1186/ISRCTN74919979
ClinicalTrials.gov identifier
EudraCT number
Public title Information technology in mental health
Scientific title Evaluation of internet-based patient support system in mental health care: a randomised controlled cost-effectiveness analysis
Acronym Mieli.Net
Serial number at source 207384
Study hypothesis 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?
Lay summary Not provided at time of registration
Ethics approval Ethics Committee of Pirkanmaa Hospital District approved on the 13th December 2004 (ref: ETL R01181)
Study design Randomised controlled trial
Countries of recruitment Finland
Disease/condition/study domain Schizophrenia, schizotypal disorders or delusional disorders
Participants - 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])
Participants - exclusion criteria 1. Unable to use the Finnish language
2. Unable to give written informed consent to participate
Anticipated start date 14/03/2005
Anticipated end date 04/10/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet (Finnish only)
Target number of participants 300
Interventions 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.
Primary outcome measure(s) Insight: The Schedule for the Assessment of Insight (SAI), measured at baseline (BL), 1, 3, 6 and 12 months
Secondary outcome measure(s) 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.
Sources of funding 1. The Academy of Finland (Finland) (ref: 207384)
2. The Jalmari and Rauha Ahokas Foundation (Finland)
3. The Finnish Cultural Foundation Uusimaa Regional Fund (Finland)
4. The Hospital District of Helsinki and Uusimaa (Finland)
5. The Pirkanmaa Hospital District (Finland)
Trial website http://users.utu.fi/mava/index2.html
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22381805
Contact name Prof  Maritta  Välimäki
  Address Department of Nursing Science
  City/town Turku
  Zip/Postcode 20014
  Country Finland
  Tel +358 (0)2 333 8495
  Fax +358 (0)2 333 8400
  Email mava@utu.fi
Sponsor Academy of Finland (Finland)
  Address Vilhonvuorenkatu 6
PL 99
  City/town Helsinki
  Zip/Postcode 00501
  Country Finland
  Sponsor website: http://www.aka.fi/en-gb/A/
Date applied 07/12/2009
Last edited 11/09/2012
Date ISRCTN assigned 07/01/2010
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