Clinical Effect Size of an Educational Intervention in the Home and Compliance on People Who Suffer From Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Background. Cognitive, communication and physical weakness combined with environmental
      changes frequently cause changes in roles, routines and daily occupations. The educational
      intervention combines the best choice for teaching new behaviours since it involves the
      active participation of the patient in learning.

      Methods. Design. Randomized clinical trial. Participants. Total sample: 80 adults who have
      suffered a stroke with moderate severity and who have been discharged to their homes.Outcome
      variables. BI, FIM, MMSE, CNS, SIS-16, TCT, MRS, MSPSS, QLSF, FRT, RT, TUG, TST, a portable
      dynamometer and a sociodemographic questionnaire. Data analysis. Descriptive analyses will
      include mean and 95% CI of the values for each variable. The Kolmogov-Smirnov (KS) test and a
      2x2 mixed model ANOVA will be used. Intergroup effect sizes will be calculated (Cohen's d).
    

Detailed description: 
      Background. Stroke is the third leading cause of death and the leading cause of long-term
      neurological disability in the world. Cognitive, communication and physical weakness combined
      with environmental changes frequently cause changes in roles, routines and daily occupations.
      The educational intervention combines didactic and interactive intervention, which combines
      the best choice for teaching new behaviours since it involves the active participation of the
      patient in learning. Nowadays there are many types of intervention or means to increase
      adherence to treatment.

      Methods. This study is a randomized clinical trial. Participants. The total sample will
      consist of 80 adults who have suffered a stroke with moderate severity and who have been
      discharged to their homes in the 3 months prior to recruitment to the study. Outcome
      variables. 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, the Timed-Stands Test, a portable dynamometer and a sociodemographic questionnaire.
      Data analysis. Descriptive analyses will include mean and 95% confidence intervals of the
      values for each variable. The Kolmogov-Smirnov (KS) test and a 2x2 mixed model ANOVA will be
      used. Intergroup effect sizes will be calculated (Cohen's d).

      Sample Size Calculation 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) 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.

      Procedure. Stage 1 will begin with the collection of the participants' demographic data
      through a questionnaire and by conducting various tests to measure primary and secondary
      outcome variables. Subsequently, the ergonomics of the home and the implementation of ADL
      from both the experimental group and the control group will be assessed using the HTAS tool,
      which was developed by the authors. For the development of the tool, a literature review was
      performed using the PubMed electronic database and by reviewing different practice guides
      about stroke. Subsequently, the HTAS tool was evaluated by a panel of experts composed of
      occupational therapists, physiotherapists, nurses, caregivers, and patients.

      Following the assessment of each participant's home and his or her performance of ADL, the
      therapist will provide the participants of the experimental group with a list of pieces of
      advice related to the HTAS items that were evaluated negatively. The advice will be aimed at
      changing the environment in which the participants execute the ADL. This may include
      facilitation in the execution of the ADL, promoting the active use of the affected side of
      the body in such execution, or to show them the most appropriate way of performing certain
      tasks according to their situation after the stroke.

      The evaluation of the variables and the execution of the advised tasks will be carried out at
      participants' homes 2 and 4 weeks following the initial assessment. Researchers will analyze
      and compare the data obtained from the outcome variables of the experimental group and the
      control group to check whether the educational intervention was effective in patients who
      have suffered stroke and who have been discharged to their homes. If the hypothesis is
      confirmed, the educational intervention would be implemented in the control group.

      Stage 2 For the pilot study in stage 2, one group will receive the app reminders on their
      mobile phones (MPG) and another group will not (NMPG). Placement in the first group depends
      on whether the participant has a mobile phone and if its characteristics are adapted to the
      requirements of the study. The app will provide the advice previously given by the therapist
      in the participants' homes. The timing of reminders will differ for each participant
      depending on the amount of advice given. However, in the 4 weeks of the app being used, each
      piece of advice will be given 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 or has
      not complied with the advice. After this period, the outcome variables will be analyzed in
      both groups to check whether there are differences between the MPGand NMPG groups.

      After 8 weeks, and after having removed the app from mobile phones of the MPG, we will
      reanalyze the outcome variables. Will do this by testing both groups to see whether the
      MPGparticipants have continued to perform the advised tasks provided by the therapist, and if
      differences still exist between them and the NGS group. If so, a reminder system will be
      implemented in the NMPG.
    

Intervention name(s): Educational intervention; Smartphone-based application
Intervention type(s): Behavioral; Device
Intervention description(s): All subjects received an educational intervention consist in an educational advice provides by the therapist to improve the adherence of the treatment.; Smartphone-based application group (SG) sample will have a reminder. The app will provide the advice previously given by the therapist in the participants' homes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Stroke; ADL; mHealth; App; Adherence; Home; Environment; Tool; Advice; Smartphone