Text messages to support the well being of patients with severe mental health problems

ISRCTN	ISRCTN27704027
DOI	https://doi.org/10.1186/ISRCTN27704027
Secondary identifying numbers	132581

Submission date: 12/05/2011
Registration date: 01/08/2011
Last edited: 17/07/2017

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

Contact information

Prof Maritta Välimäki
Scientific

Department of Nursing Science
University of Turku
Turku
20014
Finland

Phone	+358 (0)2 333 84 95
Email	mava@utu.fi

Study information

Study design	Multi-centre randomised controlled two-armed trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet (in Finnish)
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
Study acronym	Mobile.Net
Study objectives	SMS use will reduce service use of people with serious mental illness whose use of services has been high.
Ethics approval(s)	Ethics Committee of The Hospital District of Southwest Finland, 16/12/2010, ref: 109/180/2010
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/2011
Completion date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	3100, 1550 for both arms
Key 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
Key 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
Date of first enrolment	05/09/2011
Date of final enrolment	31/12/2013

Locations

Countries of recruitment

Finland

Study participating centre

University of Turku

Turku
20014
Finland

Sponsor information

Academy of Finland (Finland)
University/education

Vilhonvuorenkatu 6
PL 99
Helsinki
00501
Finland

Email	kirjaamo@aka.fi
Website	http://www.aka.fi/en-GB/A/
"ROR"	https://ror.org/05k73zm37

Funders

Funder type

Hospital/treatment centre

Academy of Finland (Finland) ref: 132581
Government organisation / Universities (academic only)

Alternative name(s): Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
Location: Finland

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

No information available

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

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	Peer reviewed?	Patient-facing?
Results article	results	01/10/2015	Yes	No
Results article	results	09/11/2015	Yes	No
Results article	results	21/02/2017	Yes	No
Results article	results	12/07/2017	Yes	No

Editorial Notes

27/07/2017: Publication reference added.
27/02/2017: Publication reference added.
02/09/2016: Publication reference added.