Clinical trial NCT01980641: Clinical Effect Size of an Educational Intervention in the Home and Compliance on People Who Suffer From Stroke
Official title: Clinical Effect Size of an Educational Intervention in the Home and Compliance With a Smartphone-based Reminder on People Who Suffer From Stroke: a Protocol Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
ADL
mHealth
App
Adherence
Home
Environment
Tool
Advice
Smartphone
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Barthel Index
timeFrame: Change from Baseline to 2, 4, 12 and 22 weeks
Secondary outcomes:
measure: Canadian Neurological Scale
timeFrame: Change from Baseline to 2, 4, 12 and 22 weeks
measure: Stroke impact scale-16
timeFrame: Change from Baseline to 2, 4, 12 and 22 weeks
measure: Mini-Mental State Examination
timeFrame: Change from Baseline to 2, 4, 12 and 22 weeks
measure: Functional Independence Measure
timeFrame: Change from Baseline to 2, 4, 12 and 22 weeks
measure: Trunk Control Test
timeFrame: Change from Baseline to 2, 4, 12 and 22 weeks
measure: Modified Rankin Handicap Scale
timeFrame: Change from Baseline to 2, 4, 12 and 22 weeks
measure: Perceived Social Support Scale
timeFrame: Change from Baseline to 2, 4, 12 and 22 weeks
measure: Quality of Life Scale for Stroke
timeFrame: Change from Baseline to 2, 4, 12 and 22 weeks
measure: Functional Reach test
timeFrame: Change from Baseline to 2, 4, 12 and 22 weeks
measure: Romberg Test
timeFrame: Change from Baseline to 2, 4, 12 and 22 weeks
measure: Time Up and Go
timeFrame: Baseline; 8; 18 and 28 weeks
measure: Strength testing with a portable dynamometer
timeFrame: Change from Baseline to 2, 4, 12 and 22 weeks
measure: Timed-stands test
timeFrame: Change from Baseline to 2, 4, 12 and 22 weeks
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: IBIMA
state: Malaag
city: Torremolinos
country: Spain
facility: Patronato Municipal de deportes de Torremolinos
state: Malaga
Study officials:
affiliation: University of Malaga
name: Antonio I Cuesta Vargas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.