In brief
This is the 2012 study protocol for Mobile. Net, a Finnish trial testing patient-tailored SMS reminders to support medication adherence and follow-up after psychiatric hospital discharge; it describes the planned design, not results.
What this article is about
Quick Answer
This is the 2012 study protocol for Mobile.Net, a Finnish trial testing patient-tailored SMS reminders to support medication adherence and follow-up after psychiatric hospital discharge; it describes the planned design, not results.
Student takeaways
Key Takeaways
- The protocol describes Mobile.Net as a pragmatic, multicenter randomized controlled trial across 24 sites and 45 psychiatric hospital wards in Finland, testing tailored SMS text messages against usual care.
- Eligible participants were adults 18-65 with antipsychotic medication at discharge from a psychiatric hospital, owning a mobile phone, able to use Finnish, and able to give informed consent.
- The intervention let participants choose the content, timing, and frequency of their own SMS reminders covering medication, appointments, and daily care, continuing up to 12 months or until withdrawal.
- Randomization used a computer-generated permuted block design with sealed, sequentially numbered envelopes, with wards allocated to arms and participants individually randomized within wards.
- Primary outcomes were hospital service use and 'healthy days' at 12 months from national health registers, with secondary outcomes covering coercive measures, medication, adverse events, satisfaction, social functioning, and cost, analyzed by intention-to-treat.
Student summary
Why This Research Matters
This article is a study protocol, not a results paper. It describes how researchers in Finland planned to test whether text messages sent to a mobile phone could help people with psychosis take their medication and keep follow-up appointments after leaving hospital. The trial is called Mobile.Net, and it was designed by Maritta Välimäki, Heli Hätönen, and Clive E Adams and published in JMIR Research Protocols in 2012.
Schizophrenia and related psychotic illnesses are costly, long-term conditions, and the authors note that simple, low-cost tools to support people after discharge were missing. Text messaging was chosen because mobile phones are widely available and a message can be personalized without requiring extra staff time for every contact.
The plan was a pragmatic, multicenter randomized controlled trial across 24 sites and 45 psychiatric hospital wards in Finland. Whole wards were randomized to one of two arms, and participants within each ward were then allocated individually using a computer-generated permuted block design with sealed, sequentially numbered envelopes handled by research nurses. Eligible participants were adults aged 18 to 65 being discharged from a psychiatric hospital on antipsychotic medication, who owned a mobile phone, could use Finnish, and could give informed consent. People needing only planned non-acute care or those in forensic psychiatric services were excluded. The protocol set a recruitment target of roughly 1,511 participants per arm, calculated to have 80% power to detect a 5-percentage-point reduction in hospital readmission.
In the intervention arm, participants received semiautomatic SMS messages after discharge. What made this different from many earlier text-message studies is that patients themselves chose the wording, topic, timing, and frequency of the messages, covering things like medication reminders, appointment reminders, and general daily care. Messages continued for up to 12 months, or stopped earlier if a participant asked to withdraw. Everyone in both arms kept receiving whatever usual psychiatric and nursing care their team normally provided; the SMS messages were added on top of standard care for the intervention group only.
The primary outcomes planned were service use and "healthy days" over 12 months, drawn from Finland's national health registers: whether someone was readmitted to hospital, how long it took before a first readmission, and total days spent in hospital during the year. Secondary outcomes included further service use, use of coercive measures (such as restraint or seclusion), medication-related data, adverse events, satisfaction with care and with the trial itself, social functioning, and cost. The researchers planned to analyze the results by intention-to-treat, meaning participants would be analyzed according to the group they were randomized to, regardless of how much they actually used the messages. The trial was registered publicly (ISRCTN27704027) and received ethics approval from the Hospital District of Southwest Finland in December 2010.
Because this is a protocol article, it reports no outcome results — it only describes what the researchers intended to measure and how. For nursing students, this is a useful example of how a rigorous mental-health intervention trial is designed before any data are collected: defining eligibility clearly, choosing a randomization method that limits bias, deciding outcomes in advance, and planning the statistical approach ahead of time. It also shows an interesting design choice worth discussing in class: letting patients control the content of their own reminder messages, which is meant to increase acceptability and reduce the feeling of being "nagged" by a rigid, one-size-fits-all system. Students appraising this article should notice what is, and is not, claimed: a protocol tells you the plan, not whether the plan worked.
Source abstract
Study Overview
BackgroundSchizophrenia is a high-cost, chronic, serious mental illness. There is a clear need to improve treatments and expand access to care for persons with schizophrenia, but simple, tailored interventions are missing. ObjectiveTo evaluate the impact of tailored mobile telephone text messages to encourage adherence to medication and to follow up with people with psychosis at 12 months. MethodsMobile.Net is a pragmatic randomized trial with inpatient psychiatric wards allocated to two parallel arms. The trial will include 24 sites and 45 psychiatric hospital wards providing inpatient care in Finland. The participants will be adult patients aged 18–65 years, of either sex, with antipsychotic medication (Anatomical Therapeutic Chemical classification 2011) on discharge from a psychiatric hospital, who have a mobile phone, are able to use the Finnish language, and are able to give written informed consent to participate in the study. The intervention group will receive semiautomatic system (short message service [SMS]) messages after they have been discharged from the psychiatric hospital. Patients will choose the form, content, timing, and frequency of the SMS messages related to their medication, keeping appointments, and other daily care. SMS messages will continue to the end of the study period (12 months) or until participants no longer want to receive the messages. Patients will be encouraged to contact researchers if they feel that they need to adjust the message in any way. At all times, both groups will receive usual care at the discretion of their team (psychiatry and nursing). The primary outcomes are service use and healthy days by 12 months based on routine data (admission to a psychiatric hospital, time to next hospitalization, time in hospital during this year, and healthy days). The secondary outcomes are service use, coercive measures, medication, adverse events, satisfaction with care, the intervention, and the trial, social functioning, and economic factors. Data will be collected 12 months after baseline. The outcomes are based on the national health registers and patients’ subjective evaluations. The primary analysis will be by intention-to-treat. Trial RegistrationInternational Standard Randomised Controlled Trial Number (ISRCTN): 27704027; http://www.controlled-trials.com/ISRCTN27704027 (Archived by WebCite at http://www.webcitation.org/69FkM4vcq)
Evidence appraisal
Main Findings
- The protocol describes Mobile.Net as a pragmatic, multicenter randomized controlled trial across 24 sites and 45 psychiatric hospital wards in Finland, testing tailored SMS text messages against usual care.
- Eligible participants were adults 18-65 with antipsychotic medication at discharge from a psychiatric hospital, owning a mobile phone, able to use Finnish, and able to give informed consent.
- The intervention let participants choose the content, timing, and frequency of their own SMS reminders covering medication, appointments, and daily care, continuing up to 12 months or until withdrawal.
- Randomization used a computer-generated permuted block design with sealed, sequentially numbered envelopes, with wards allocated to arms and participants individually randomized within wards.
- Primary outcomes were hospital service use and 'healthy days' at 12 months from national health registers, with secondary outcomes covering coercive measures, medication, adverse events, satisfaction, social functioning, and cost, analyzed by intention-to-treat.
Practice transfer
Clinical Relevance
- Nurses supporting discharge planning can consider that patient-controlled reminder content (rather than fixed, generic messages) was the design feature this team believed would improve acceptability of a text-messaging support tool.
- Because this is a protocol, not a results paper, nurses should not assume text messaging improves adherence or reduces readmission based on this article alone; effectiveness has to be judged from the completed trial's outcome data.
- The trial's reliance on national health-register data for hospitalization outcomes illustrates how administrative data can supplement self-report in evaluating adherence-support interventions in real practice settings.
- The inclusion of coercive measures and adverse events as secondary outcomes reflects appropriate safety monitoring practice when introducing any new communication-based intervention into psychiatric aftercare.
- The exclusion of forensic psychiatric patients and those needing only planned non-acute care is a reminder that adherence-support interventions studied in one population may need separate evaluation before extending to other psychiatric populations.
Faculty notes
Educational Relevance
This is the trial protocol for Mobile.Net, a pragmatic, multicenter, two-armed randomized controlled trial (Välimäki, Hätönen, and Adams, JMIR Research Protocols, 2012; ISRCTN27704027) evaluating tailored SMS text messaging to support medication adherence and post-discharge follow-up for adults with psychosis in Finland. It is well suited for teaching study design and critical appraisal of protocol papers, since it separates planned methodology from eventual results.
Design: the trial randomized whole psychiatric wards (24 sites, 45 wards) to intervention or control, then individually randomized participants within each ward using a computer-generated permuted block design with sequentially numbered, sealed envelopes managed by research nurses — a cluster-then-individual approach intended to limit contamination between arms while preserving individual-level allocation concealment. The protocol reports a target sample of approximately 1,511 participants per arm (roughly 3,022 total), powered at 80% to detect a 5-percentage-point absolute reduction in hospital readmission (relative risk 0.92) at the 5% significance level — useful for a discussion of a priori power calculations and what a 'pragmatic' trial design trades off versus efficacy trials.
Population: adults 18-65, discharged from psychiatric hospital wards on antipsychotic medication, owning a mobile phone, Finnish-speaking, and capable of informed consent; those in forensic psychiatric services or receiving only planned non-acute care were excluded. This is a reasonably representative discharge population for Finnish adult mental health services, though the Finnish-language and mobile-phone-ownership requirements narrow generalizability.
Intervention: a patient-led, semiautomatic SMS system in which participants chose message wording, topic (medication, appointments, daily care), timing, and frequency, continuing up to 12 months or until withdrawal. Both arms continued to receive usual psychiatric and nursing care; blinding of participants and clinical staff was not attempted (open, pragmatic design), but the protocol specifies that outcome assessors and analysts were kept masked to allocation — worth highlighting as a partial-blinding strategy appropriate to a behavioral/service intervention.
Outcomes: primary outcomes were hospital service use and 'healthy days' at 12 months (admission, time to next hospitalization, total inpatient days) drawn from Finnish national health registers; secondary outcomes spanned coercive measures, medication data, adverse events, satisfaction, social functioning, and economic factors. Analysis was planned as intention-to-treat. A notable protocol-stage limitation the authors flagged themselves is a roughly one-year lag in national register data, which precluded any planned interim analysis.
For faculty use: this protocol pairs well with the eventual results paper (Välimäki et al., J Med Internet Res 2017;19(7):e245; PMC5529737), which reported 1,139 participants randomized and found the intervention did not significantly reduce readmission (43.0% vs 38.8%, RR 1.11, p=0.28) or improve most secondary outcomes, though SMS-group participants who were readmitted had somewhat better global functioning, and overall costs were higher in the SMS arm. Comparing protocol to outcome paper is a strong exercise for teaching trial registration, outcome-switching checks, and the gap between a promising, well-designed pragmatic trial and a null clinical result — and for discussing why 'ineffectual' findings are still valuable evidence for practice and policy in digital mental health.
Critical appraisal
Limitations
- As a protocol paper, no outcome results are reported here; conclusions about whether the intervention worked cannot be drawn from this article.
- The authors themselves flagged a roughly one-year lag in national register data, which prevented the planned interim analysis during the trial.
- Eligibility required Finnish-language ability and mobile phone ownership, which may limit how well the planned sample generalizes to non-Finnish-speaking or lower-resource populations.
Classroom use
Discussion Questions
- Why is it important to distinguish a trial protocol paper, like this one, from a results paper when critically appraising evidence?
- What are the advantages and risks of letting patients choose the content, timing, and frequency of their own SMS reminders rather than using a fixed message schedule?
- How does randomizing whole psychiatric wards, then individuals within wards, help reduce contamination between the intervention and control groups, and what risks remain?
- Why might outcome assessors and analysts be masked to allocation even when participants and clinical staff are not, in a pragmatic trial like this one?
- What ethical considerations arise when recruiting adults with psychosis, at the point of hospital discharge, into a randomized trial?
- How might reliance on national health-register data for outcomes like readmission and hospital days differ from relying on self-report, and what are the tradeoffs?
- Why did the researchers include coercive measures and adverse events as secondary outcomes, and what does this suggest about safety monitoring in behavioral intervention trials?
- What limitations does excluding non-Finnish speakers and people without mobile phones place on the generalizability of this trial's eventual findings?
- If you were designing a similar SMS adherence-support trial in a Canadian nursing context, what changes would you make to the eligibility criteria or intervention design?
- The completed Mobile.Net trial later reported no significant reduction in readmission from SMS messaging. How should a protocol like this be interpreted differently once its results are known, and why do null results still matter for practice?
Knowledge check
Quiz
1. What type of article is this Mobile.Net publication?
- A completed trial results paper
- A study protocol for a planned trial
- A systematic review
- A qualitative case study
Rationale: The abstract describes 'Methods and Protocol for a Multicenter Randomized Controlled Two-Armed Trial' with no reported outcome results, indicating this is a protocol paper.
2. How many psychiatric hospital sites and wards did the protocol plan to include in Finland?
- 10 sites and 20 wards
- 24 sites and 45 wards
- 50 sites and 100 wards
- 5 sites and 10 wards
Rationale: The abstract states the trial 'will include 24 sites and 45 psychiatric hospital wards providing inpatient care in Finland.'
3. Who was eligible to participate in the trial, according to the protocol?
- Adults 18-65 on antipsychotic medication at discharge, with a mobile phone and Finnish language ability
- Children under 18 with any psychiatric diagnosis
- Adults over 65 in long-term forensic psychiatric care
- Anyone regardless of medication status or language
Rationale: The abstract specifies participants aged 18-65 on antipsychotic medication at discharge, with a mobile phone, Finnish language ability, and capacity to consent.
4. What made the SMS intervention in this trial distinctive compared to a generic reminder system?
- Messages were sent only by physicians
- Patients chose the form, content, timing, and frequency of their own messages
- Messages were identical for every participant
- Messages were sent only once at discharge
Rationale: The abstract states 'Patients will choose the form, content, timing, and frequency of the SMS messages related to their medication, keeping appointments, and other daily care.'
5. What were the primary outcomes planned for this trial?
- Patient satisfaction scores only
- Service use and healthy days by 12 months, based on routine register data
- Cost of the intervention only
- Number of text messages sent per participant
Rationale: The abstract states: 'The primary outcomes are service use and healthy days by 12 months based on routine data.'
6. What randomization method did the full protocol describe for allocating individual participants within wards?
- Simple coin flip by nursing staff
- A computer-generated permuted block design with sealed, sequentially numbered envelopes
- Participants chose their own group
- Alphabetical order of last name
Rationale: The full protocol describes a computer-generated permuted block design using sealed envelopes with identification numbers, sequentially assigned by research nurses.
7. Approximately what sample size per arm did the protocol's power calculation target?
- 100 per arm
- 500 per arm
- About 1,511 per arm
- 10,000 per arm
Rationale: The full protocol reports a target of approximately 1,511 participants per arm for 80% power to detect a 5-percentage-point reduction in hospital admissions.
8. What analysis approach did the researchers plan to use for the primary outcomes?
- Per-protocol analysis only
- Intention-to-treat analysis
- Case-control matching
- Post-hoc subgroup analysis only
Rationale: The abstract states: 'The primary analysis will be by intention-to-treat.'
9. What limitation did the researchers themselves note about the national health register data used for outcomes?
- The registers were not available at all
- There was roughly a one-year lag in register data, preventing a planned interim analysis
- The registers only covered private hospitals
- Register data was collected daily with no delay
Rationale: The full protocol notes a 'a 1-year lag time' in register data prevented interim analysis after recruitment began.
10. Under what trial registry number was Mobile.Net registered?
- NCT01234567
- ISRCTN27704027
- PMID23611874
- DOI10.2196
Rationale: The abstract states: 'Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN): 27704027.'
Study cards
Flashcards
What is Mobile.Net?
A pragmatic, multicenter randomized controlled trial testing tailored SMS text messages to encourage medication adherence and follow-up for adults with psychosis discharged from Finnish psychiatric hospitals.
Who authored this Mobile.Net protocol paper?
Maritta Välimäki, Heli Hätönen, and Clive E Adams, published in JMIR Research Protocols in 2012.
How many sites and wards did the trial plan to recruit from?
24 sites and 45 psychiatric hospital wards in Finland.
What age range was eligible for the trial?
Adults aged 18 to 65 years.
What medication requirement did eligible participants need to meet?
They needed to be on antipsychotic medication at the time of discharge from a psychiatric hospital.
What other eligibility requirements did participants need beyond age and medication?
Owning a mobile phone, ability to use the Finnish language, and capacity to give written informed consent.
What made the intervention's SMS messages 'tailored'?
Participants chose the form, content, timing, and frequency of their own messages related to medication, appointments, and daily care.
How long did the SMS intervention continue for participants?
Up to 12 months, or until the participant no longer wanted to receive messages.
What did the control group receive in this trial?
Usual psychiatric and nursing care at the discretion of their care team, without the added SMS messaging system.
What were the trial's primary outcomes?
Service use and 'healthy days' by 12 months, including hospital admission, time to next hospitalization, and total time hospitalized, based on national register data.
Name examples of the trial's secondary outcomes.
Service use, coercive measures, medication, adverse events, satisfaction with care, social functioning, and economic factors.
How was randomization structured across wards and individuals?
Wards were allocated to one of two arms, and individual participants within each ward were then randomized using a computer-generated permuted block design with sealed, sequentially numbered envelopes.
Was this trial blinded?
It was open-label for participants and staff, but outcome assessors and data analysts were masked to group allocation.
What sample size did the protocol's power calculation target?
Approximately 1,511 participants per arm (about 3,022 total), for 80% power to detect a 5-percentage-point reduction in hospital readmission.
What analysis method was planned for the primary outcomes?
Intention-to-treat analysis.
What limitation regarding data timing did the researchers note?
A roughly one-year lag in national register data prevented the planned interim analysis.
Under what registration number was this trial registered?
ISRCTN27704027.
Which populations were excluded from the trial?
People needing only planned non-acute treatment and those in forensic psychiatric services.
When and by whom was ethical approval granted for this trial?
By the Ethics Committee of the Hospital District of Southwest Finland, approved December 16, 2010.
What did the later completed Mobile.Net trial (published 2017) find about SMS messaging and readmission?
It found no significant reduction in psychiatric hospital readmission (43.0% SMS group vs 38.8% control, RR 1.11, p=0.28), and the authors concluded the SMS approach was ineffectual for the primary clinical outcomes, though this is reported in a separate later results paper, not this protocol article.
Search-ready answers
Frequently asked questions
What is the Mobile.Net trial about?
Mobile.Net is a Finnish multicenter randomized controlled trial testing whether tailored SMS text messages, chosen in content and timing by the patients themselves, help people with psychosis stick to medication and keep follow-up appointments after hospital discharge.
Is this article a study protocol or a results paper?
It is a study protocol, published in 2012, describing the planned design and methods before the trial's outcomes were known; it does not report whether the intervention worked.
Who was eligible to join the Mobile.Net trial?
Adults aged 18-65 discharged from a Finnish psychiatric hospital on antipsychotic medication, who owned a mobile phone, could use Finnish, and could give informed consent.
How were participants randomized in this trial?
Wards were allocated to one of two study arms, and within each ward individual participants were randomized using a computer-generated permuted block design with sealed, sequentially numbered envelopes managed by research nurses.
What made the SMS messages in this study different from a standard reminder system?
Patients chose the wording, topic, timing, and frequency of their own messages, covering things like medication reminders, appointments, and daily care, rather than receiving a fixed generic message.
What outcomes did the researchers plan to measure?
Primary outcomes were hospital service use and 'healthy days' at 12 months from national health registers; secondary outcomes included coercive measures, medication data, adverse events, satisfaction, social functioning, and cost.
How large a sample did the trial aim to recruit?
The protocol's power calculation targeted about 1,511 participants per arm (roughly 3,022 total) to detect a 5-percentage-point reduction in hospital readmission with 80% power.
What limitation did the authors identify about the data sources used?
They noted a roughly one-year lag in the national health register data, which prevented the interim analysis they had originally planned.
Where was this trial registered, and what was its registration number?
It was registered with the International Standard Randomised Controlled Trial Number registry as ISRCTN27704027.
Did the completed Mobile.Net trial ultimately show that SMS reminders reduced hospital readmission?
According to the later published results (a separate 2017 paper from the same research group, not this protocol article), the SMS intervention did not significantly reduce readmission and was described by the authors as ineffectual for the main clinical outcomes, though readmitted SMS-group participants had somewhat better global functioning.