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

NCT ID: NCT01980641

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2018-02-28

Brief 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Assessment of each participant's home and his or her performance of ADL.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental group

Educational intervention: Assessment of each participant's home and his or her performance of ADL and the therapist will provide to the participants of the experimental group a list of advice related to the HTAS items that are evaluated negatively.

Group Type: EXPERIMENTAL

Educational intervention

Intervention Type: BEHAVIORAL

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

Application smartphone-based group

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.

Group Type: EXPERIMENTAL

Educational intervention

Intervention Type: BEHAVIORAL

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

Intervention Type: DEVICE

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.

Non Application smartphone-based group

Non Smartphone-based application group (NSG) sample won't have a reminder

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Educational intervention

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Acute Stroke (<3 months since the discharge to their homes)
• A score from 20 to 50 on Barthel Index
• A score from 35 to 75 on Functional Independence Measure

Exclusion Criteria

• Severe cognitive impairment (scoring 0-17 in the Mini-Mental State Examination)
• Inability to walk 3 meters without physical assistance
• Inability to stay standing more than 30 "without physical support
• Serious communication or comprehension problems
• Surgical intervention in lower limbs 12 months prior to recruitment
• Secondary neurological pathology
• Severe cardiovascular, respiratory, orthopedic or metabolic problems

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Dr. Antonio I Cuesta-Vargas

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio I Cuesta Vargas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Malaga

Locations

IBIMA

Málaga, Malaag, Spain

Patronato Municipal de deportes de Torremolinos

Torremolinos, Malaga, Spain

Countries

Spain

References

Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.

Reference Type: DERIVED

PMID: 34813082 (View on PubMed)

Merchan-Baeza JA, Gonzalez-Sanchez M, Cuesta-Vargas A. Clinical effect size of an educational intervention in the home and compliance with mobile phone-based reminders for people who suffer from stroke: protocol of a randomized controlled trial. JMIR Res Protoc. 2015 Mar 10;4(1):e33. doi: 10.2196/resprot.4034.

Reference Type: DERIVED

PMID: 25757808 (View on PubMed)

Related Links

http://www.uma.es

University of Malaga

Other Identifiers

FCCSS-15-2013

Identifier Type: -

Identifier Source: org_study_id