Clinical Effect Size of an Educational Intervention in the Home and Compliance on People Who Suffer From Stroke

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Educational intervention Behavioral
    Intervention Desc: All subjects received an educational intervention consist in an educational advice provides by the therapist to improve the adherence of the treatment.
    ARM 1: Kind: Experimental
    Label: Control group
    Description: Follow up detraining effect of multimodal intervention
    ARM 2: Kind: Experimental
    Label: Application smartphone-based group
    Description: Smartphone-based application group (SG) sample will have a reminder to do Phisical activity everyday where patients will have to select if they have done or they haven´t done physical activity.
    ARM 3: Kind: Experimental
    Label: Experimental group
    Description: Assessment of each participant's home and his or her performance of ADL, the therapist will provide to the participants of the experimental group a list of advice related to the HTAS items that are evaluated negatively.
  • Smartphone Device
    ARM 1: Kind: Experimental
    Label: Application smartphone-based group
    Description: Smartphone-based application group (SG) sample will have a reminder to do Phisical activity everyday where patients will have to select if they have done or they haven´t done physical activity.
  • Smartphone-based application Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Application smartphone-based group
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Investigator)
  • Purpose: Treatment
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Barthel Index Changes from Baseline to 8; 18 and 28 weeks Yes
Secondary Canadian Neurological Scale Change from Baseline to 8, 18 and 28 weeks Yes
Secondary Stroke impact scale-16 Changes from Baseline; 8; 18 and 28 weeks Yes
Secondary Mini-Mental State Examination Changes from Baseline; 8; 18 and 28 weeks Yes
Secondary Functional Independence Measure Changes from Baseline; 8; 18 and 28 weeks Yes
Secondary Trunk Control Test Baseline; 8; 18 and 28 weeks Yes
Secondary Modified Rankin Handicap Scale Baseline; 8; 18 and 28 weeks Yes
Secondary Escala de Apoyo Social Percibido Baseline; 8; 18 and 28 weeks Yes
Secondary Escala de Calidad de Vida para el Ictus Baseline; 8; 18 and 28 weeks Yes
Secondary Functional Reach test Baseline; 8; 18 and 28 weeks Yes
Secondary Romberg Test Baseline; 8; 18 and 28 weeks Yes
Secondary Time Up and Go Baseline; 8; 18 and 28 weeks Yes
Secondary Strength testing with a portable dynamometer Baseline; 8; 18 and 28 weeks Yes
Secondary Timed-stands test Baseline; 8; 18 and 28 weeks Yes
Secondary Perceived Social Support Scale Change from Baseline to 2, 4, 12 and 22 weeks Yes
Secondary Quality of Life Scale for Stroke Change from Baseline to 2, 4, 12 and 22 weeks Yes

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