NCT01980641

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

September 30, 2019

Status Verified

March 1, 2017

Enrollment Period

4.4 years

First QC Date

October 14, 2013

Last Update Submit

September 27, 2019

Conditions

Stroke

Keywords

StrokeADLmHealthAppAdherenceHomeEnvironmentToolAdviceSmartphone

Outcome Measures

Primary Outcomes (1)

  • Barthel Index

    The 10-item Barthel Index was published in 1965 as a simple index of functional independence, particularly in personal and domestic activities of daily living. This instrument consists of 10 items on activities of daily living (grooming, dressing, bathing, and bowel and bladder status), each with 2 or 4 response categories (0-3 points).Total score range from 0 to 100. Houlden H, Edwards M, McNeil J, Greenwood R. Use of the Barthel Index and the Functional Independence Measure during early inpatient rehabilitation after single incident brain injury. Clin Rehabil. 2006 Feb;20(2):153-9. Grauwmeijer E, Heijenbrok-Kal MH, Haitsma IK, Ribbers GM. A prospective study on employment outcome 3 years after moderate to severe traumatic brain injury. Arch Phys Med Rehabil. 2012 Jun;93(6):993-9. Collin C, Wade DT, Davies S, Horne V. The Barthel ADL Index: a reliability study. Int Disabil Stud. 1988;10(2):61-3.

    Change from Baseline to 2, 4, 12 and 22 weeks

Secondary Outcomes (13)

  • Canadian Neurological Scale

    Change from Baseline to 2, 4, 12 and 22 weeks

  • Stroke impact scale-16

    Change from Baseline to 2, 4, 12 and 22 weeks

  • Mini-Mental State Examination

    Change from Baseline to 2, 4, 12 and 22 weeks

  • Functional Independence Measure

    Change from Baseline to 2, 4, 12 and 22 weeks

  • Trunk Control Test

    Change from Baseline to 2, 4, 12 and 22 weeks

  • +8 more secondary outcomes

Study Arms (4)

Control group

NO INTERVENTION

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

Experimental group

EXPERIMENTAL

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.

Behavioral: Educational intervention

Application smartphone-based group

EXPERIMENTAL

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.

Behavioral: Educational interventionDevice: Smartphone-based application

Non Application smartphone-based group

NO INTERVENTION

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

Interventions

Educational interventionBEHAVIORAL

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 groupExperimental group
Smartphone-based applicationDEVICE

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.

Application smartphone-based group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IBIMA

Málaga, Malaag, 29017, Spain

Location

Patronato Municipal de deportes de Torremolinos

Torremolinos, Malaga, 29620, Spain

Location

Related Publications (2)

  • 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.

    PMID: 34813082DERIVED

  • 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.

    PMID: 25757808DERIVED

Related Links

MeSH Terms

Conditions

StrokeAlzheimer Disease

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDementiaTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Antonio I Cuesta Vargas, PhD

    University of Malaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 14, 2013

First Posted

November 11, 2013

Study Start

September 1, 2013

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

September 30, 2019

Record last verified: 2017-03

Locations

ES(2)