This study is a clinical randomized controlled trial (RCT) and will be conducted following the CONSORT rules for reporting [36]. This trial has been registered with ClinicalTrials.gov (NCT01980641).

The total sample will consist of 80 adults who have suffered a stroke with moderate severity (score between 0 and 49 on the Barthel Index [37]), who have been discharged to their homes in the 3 months prior to recruitment to the study [28]. The sample will be taken from the Carlos Haya Hospital complex in Málaga, Spain.

Individuals with dementia or other severe cognitive impairment (scoring 0 to 17 in the Mini-Mental State Examination) will not be included [38].

In stage 1, the sample will be divided into two groups of 40 participants each—experimental group and control group. The allocation and the randomization will be performed by a blinded researcher. The assignment of subjects to each group will be made through a system of sealed envelopes. Subsequently, for the pilot study in stage 2, we will create a group that will receive the app reminders on their mobile phones—the mobile phone group—and another group that will not receive the app reminder—the no mobile phone group. Group allocation will depend on whether the participant has a mobile phone and if its characteristics are adapted to the requirements of the study.

The therapist will go to each participant's home and perform an ergonomic assessment of the home. The therapist will also assess the execution of ADL by the participant using the home therapeutic advice for people who suffer stroke (HTAS) tool, which is a checklist of 60 items—the therapist will mark those items he valued as deficient. Later, with the experimental group, the therapist will mark on the participant’s advice sheet those items that were rated negatively and will advise them on how to solve these shortcomings. With this advice, the therapist will educate participants on the correct or easiest way to perform their daily tasks, on which adaptations they should make at home, and on what kind of technical assistance could be useful for them. Previous studies on the impact of stroke in patients have demonstrated that cognitive, communication, and physical weakness combined with environmental changes frequently cause changes in roles, routines, and daily occupations [8-11].

In stage 2 of the study, the app will be installed on the mobile phones of participants in the mobile phone group, which will remind them of the advice previously offered by the therapist. The timing of reminders will differ for each participant depending on the amount of advice they received. However, in the 18 weeks of the app being used, each piece of advice will be given as a reminder three times. The mobile phone will beep once for each piece of advice and the participant must check and mark the option indicating whether he has complied with the advice or not. Participants who will take part in the app intervention will have to answer at least 80% of the messages.

The app used in the study is called isoTimer (see Figure 1) and will be installed on participants’ phones who have a mobile phone with Android OS 3.2 or higher. For correct use of the app, the Google Calendar app will also be installed through which educational advice will be implemented and synchronized on the day and time scheduled by the researcher.

Because of the complications that can occur in this population with the use of mobile phones, the app has been designed to open and start working automatically when the mobile phone is switched on. At no time does the participant have to open the app.

The app works as a reminder, so that the daily educational advice will appear on the screen and the participant must indicate whether the task has been carried out. These responses will be saved in the participants’ mobile phones and then the researcher will download them to be added to the database.

To carry out this study we will follow the guideline for Good Clinical Practice (GCP) from the International Conference on Harmonisation (ICH), thus guaranteeing protection of the rights, safety, and welfare of trial subjects in accordance with the principles of the Declaration of Helsinki. This will also guarantee the credibility of the clinical trial data.

Before any intervention, each participant and his/her family will be presented with an information sheet and an informed-consent form. This form will explain the study (the voluntary nature thereof), the protection of personal data in accordance with the Organic Law on Personal Data Protection 19/55, as well as their freedom to leave the study at any time they choose.

When the agreement is signed, a copy will be given to each participant, which they will hand in at the clinical trial.

The outcome measure of this study will allow us to know and assess the level of patient dependency, cognitive ability, quality of life, social support, and physical condition. All of these factors will be measured by the Barthel Index, the Functional Independence Measure, the Mini-Mental State Examination, the Canadian Neurological Scale, the Stroke Impact Scale-16, the Trunk Control Test, the Modified Rankin Scale, the Multidimensional Scale of Perceived Social Support, the Quality of Life Scale for Stroke, the Functional Reach Test, the Romberg Test, the Time Up and Go test, the Timed-Stands Test, a portable dynamometer, and a sociodemographic questionnaire (see Table 1).

In addition, visits to the emergency department, the general practitioner, and specialists after discharge from hospital to home, as well as taking drugs associated with stroke, will be controlled.

Descriptive analyses will include mean, standard deviation, and 95% confidence intervals of the values for each variable. The normality of the variables will be performed using the Kolmogov-Smirnov (KS) test. Preintervention values prior to each condition will be compared. A 2x2 mixed-model analysis of variance (ANOVA) with supplementation (mobile phone group or no mobile phone group) as the between-subjects variable, and time (pre- and postintervention) as the within-subjects variable will be used. Intergroup effect sizes will be calculated (Cohen’s d). An effect size <0.2 reflects a negligible difference, between ≥0.5 and ≤0.8 a moderate difference, and ≥0.8 a large difference. A P value <.05 will be considered statistically significant. Data will be analyzed using SPSS version 19.0.

A power analysis was conducted using the program G*Power 3.1. A priori, a sample of approximately 40 participants per group for the stage 1 intervention is needed to detect a significant difference (17.3 in the FIM [39]) between the experimental group and the control group (effect size d=0.59, alpha=.05, beta=.08). The randomization will be performed by a blinded researcher.

The aim of this study is that patients who suffer stroke and who have been discharged to their homes improve the performance of ADL in the home environment, in spite of the restrictions caused by the stroke, after advice given by the therapist. A secondary aim is that these patients continue the treatment through a reminder app installed on their mobile phones (isoTimer).

Some studies have analyzed the ergonomics of the workplace through a tool and other studies have carried out different kinds of treatments at home on people with stroke. Because of this, it is thought that an educational intervention at home with people who have suffered a stroke and who have been discharged to their homes could be an innovative and necessary study.

The use of a mobile phone reminder app is an innovative method because the mobile phone has been used with people who have suffered a stroke, but it has not been used before as a means of improving adherence to treatment at home with this population. This method could result in advances in facilitating the continuity of treatment in this population once they return to their homes.

This study could be a breakthrough in the treatment of people who have suffered a stroke and who have been discharged to their homes, since during the first months the largest changes occur and it is essential to continue the rehabilitation treatment received at the hospital. The HTAS tool would allow a proper assessment of the home environment and the implementation of the ADL by the patient, bringing some useful advice that will guide them through the process of recovery of functional independence. Also, being able to have an app that reminds them of the advice provided by the therapist ensures that all patients who suffer a stroke and are discharged to their homes do not encounter barriers in the environment, and that they can advance their functional independence. Additionally, this continuity in the treatment without interruption and its early implementation would favor not only the recovery and rehabilitation of the patient, but could also result in cost savings in care services.

The aim of this project was that patients who have suffered a stroke and been discharged to their homes can continue with the rehabilitation treatment received at the hospital. This treatment should occur without interruption and in the shortest time possible in order for patients to achieve the highest possible level of functional independence, and so that their readaptation to the environment is optimal. To do this, there will be a therapist intervention using the HTAS tool and an app (isoTimer) that will communicate reminders of the advice. The potential effectiveness of this educational intervention lies in the active participation of the patient.