Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Maritta Välimäki
ORCID ID
Contact details
Department of Nursing Science
Turku
20014
Finland
+358 (0)2 333 8495
mava@utu.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
207384
Study information
Scientific title
Evaluation of internet-based patient support system in mental health care: a randomised controlled cost-effectiveness analysis
Acronym
Mieli.Net
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?
Ethics approval
Ethics Committee of Pirkanmaa Hospital District approved on the 13th December 2004 (ref: ETL R01181)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet (Finnish only)
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
14/03/2005
Overall trial end date
04/10/2007
Reason abandoned
Eligibility
Participant 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])
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. Unable to use the Finnish language
2. Unable to give written informed consent to participate
Recruitment start date
14/03/2005
Recruitment end date
04/10/2007
Locations
Countries of recruitment
Finland
Trial participating centre
Department of Nursing Science
Turku
20014
Finland
Sponsor information
Organisation
Academy of Finland (Finland)
Sponsor details
Vilhonvuorenkatu 6
PL 99
Helsinki
00501
Finland
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Academy of Finland (Finland) (ref: 207384)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Jalmari and Rauha Ahokas Foundation (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Finnish Cultural Foundation Uusimaa Regional Fund (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Hospital District of Helsinki and Uusimaa (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Pirkanmaa Hospital District (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22381805
Publication citations
-
Results
Anttila M, Välimäki M, Hätönen H, Luukkaala T, Kaila M, Use of web-based patient education sessions on psychiatric wards., Int J Med Inform, 2012, 81, 6, 424-433, doi: 10.1016/j.ijmedinf.2012.02.004.