Condition category
Mental and Behavioural Disorders
Date applied
07/12/2009
Date assigned
07/01/2010
Last edited
11/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://users.utu.fi/mava/index2.html

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

http://www.aka.fi/en-gb/A/

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

  1. 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.

Additional files

Editorial Notes