Condition category
Mental and Behavioural Disorders
Date applied
12/05/2011
Date assigned
01/08/2011
Last edited
02/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
University of Turku
Turku
20014
Finland
+358 (0)2 333 84 95
mava@utu.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

132581

Study information

Scientific title

Mobile telephone text messages to encourage compliance with medication and to follow up with people with psychosis: a multi-centre randomised controlled two-armed trial

Acronym

Mobile.Net

Study hypothesis

SMS use will reduce service use of people with serious mental illness whose use of services has been high

Ethics approval

Ethics Committee of The Hospital District of Southwest Finland, 16/12/2010, ref:109/180/2010

Study design

Multi-centre randomised controlled two-armed trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (in Finnish)

Condition

Psychosis

Intervention

Intervention group will receive the SMS messages (a semi-automatic system) at out-patient care after their discharge from acute psychiatric in-patient care. The SMS messages to the patients will continue for the end of the study period or until they wish these messages to stop. The intervention will be consumer-led rather than researcher-led to increase acceptability of the prompt. Therefore, the format and frequency of the messages to be sent will be all agreed with the patient. For example, patients choose text messages content areas related to their medication and/or keeping appointments. Additionally, they can choose messages related to other daily issues (e.g. taking care of hygiene, physical exercise, nutrition, day routines, wearing, avoiding danger, communication, taking care of pets, following rules, hobbies, work or other activities, house hold, symptom management or other supporting messages). The content of the messages mentioned have been designed by patients in rehabilitative units in Finland. Patients/their career can inform the Data Manager who can change the system based on patients' wishes. In addition, patients in intervention group receive standard care with face-to-face sessions with staff.

Patients in control group ('treatment as usual') receive standard care.

Total duration of treatment: 12 months, total duration of follow-up: 12 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Admission to psychiatric hospital (register data). Data collection will take 12 months follow-up from baseline.

Secondary outcome measures

1. Use of social and health care services. Data collection will take 12 months follow-up from baseline:
1.1. Involuntary treatment in psychiatric hospital (register data)
1.2. Use of coercive measures (register data)
1.3. Use of specialiced mental health in- and out-patient care (register data)
1.4. Use of primary health care, health care centers (register data)
1.5. Use of reimbursements of National Health Insurance (register data)
2. Adverse events (register data). Data collection will take 12 months follow-up from baseline.
3. Patient requests to stop the text-messages. Data collection will take 12 months follow-up from baseline
4. Drop-outs, data collection will take 12 months follow-up from baseline
5. Quality of life (Q-Les-Q, Endicott ym. 1993, 14 questions). Data collection will take 12 months follow-up at two points: at baseline, and at 12 months
6. Satisfaction with treatment Client Satisfaction Questionnaire(CSQ-8). Data collection will take 12 months follow-up at two points: at baseline, and at 12 months

Overall trial start date

01/06/2011

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 - 65 years, either sex
2. Antipsychotic medication
3. Discharged from psychiatric hospital
4. Have mobile phone
5. Able to use Finnish language
6. Able to give written informed consent to participate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3100, 1550 for both arms

Participant exclusion criteria

1. Unable to use the Finnish language
2. Unable to give written informed consent to participate
3. Planned non-acute treatment period or visit in-psychiatric hospital
4. Forensic patients

Recruitment start date

05/09/2011

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Finland

Trial participating centre

University of Turku
Turku
20014
Finland

Sponsor information

Organisation

Academy of Finland (Finland)

Sponsor details

Vilhonvuorenkatu 6
PL 99
Helsinki
00501
Finland
-
kirjaamo@aka.fi

Sponsor type

University/education

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Academy of Finland (Finland) ref: 132581

Alternative name(s)

Academy of Finland

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Finland

Funder name

Satakunta Hospital District, EVO (Finland) ref: 12/2010, 81096

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

South-West Hospital District, EVO (Finland) ref: 13893

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26293215
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553830

Publication citations

Additional files

Editorial Notes

02/09/2016: Publication reference added.