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

NCT01980641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-09-30

No results posted yet for this study

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).

Conditions

Interventions

BEHAVIORAL

Educational intervention

All subjects received an educational intervention consist in an educational advice provides by the therapist to improve the adherence of the treatment.

DEVICE

Smartphone-based application

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.

Sponsors & Collaborators

  • University of Malaga

    lead OTHER

Principal Investigators

  • Antonio I Cuesta Vargas, PhD · University of Malaga

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01980641 on ClinicalTrials.gov