Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507098
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-05
Brief Title:
Effectiveness of Telematic Instruction to Patients in the Correct Performance of Respiratory Polygraphy at Home
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Telematic Instruction to Patients in the Correct Performance of Respiratory Polygraphy at Home
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this trial is to evaluate the use of a video-assisted training for the use of a home-respiratory polygraph for the diagnosis of obstructive sleep apnea compared to standard training by a nurse
A clinical trial is conducted to this effect One arm is video-assisted training and the other arm is conventional training by a nurse
A clinical trial is conducted to this effect One arm is video-assisted training and the other arm is conventional training by a nurse
Detailed Description:
Hypotheses
1 The use of a video for the correct performance of home respiratory polygraphy RP reduces the number of errors derived from poor placement of the polygraph
2 The degree of satisfaction of telematic instruction will be higher than that of in-person instruction
3 Telematic instruction will achieve a reduction in care time allocated to instruction for the nursing staff of the Pneumology Day Hospital
Objectives
Main objective
Compare the number of errors in the RP record derived from poor placement of the polygraph between an in-person nursing instruction and a telematic instruction using a video
Secondary objectives
Compare the number of total errors in the RP record between an in-person nursing instruction and a telematic instruction using a popular video
Compare the level of patient satisfaction between in-person nursing instruction and telematic instruction using a video
Compare the time invested in nursing at the Pneumology Day Hospital in the delivery and instruction of polygraph use between in-person instruction and telematic instruction
Study design
Open randomized clinica trial with two arms of intervention instruction in the functioning of the respiratory polygraph according to usual clinical practice and instruction in audiovisual media
Study population Patients with suspected Obstructive sleep apnea OSA who have been indicated for performing a home respiratory polygraphy for the first time
Study exhibition Consecutive patients with OSA who come to the Pneumology Service for the collection of a respiratory polygraph for the performance of a home PR for the first time Recruitment is made at the time you go to collect the respiratory polygraph if you decide to participate in the study after signing the informed consent and checking the inclusion and exclusion criteria At that moment randomization will be made and they will be assigned to one of the two intervention groups
Statistical analysis
The data will be registered in an electronic data base in a dissociated manner so that the analyzers will not be able to connect the identity of the persons participating in the study The database will be stored in the CSdM information system along with standard security measures The analysis plan includes
1 Description of the main characteristics of the study sample age gender participation of a third person number of views etc including values and typical deviations for numerical variables and percentages for categorical variables
2 Assessment of the homogeneity andor comparability of the two study groups The categorical variables are compared using the Khi al quadrat test or the Fisher exact test and the numerical variables with the T-Student test or the Man Whitney U test
3 Comparison of the main results measures percentage of valid PRs number of errors satisfaction investment times between the two study groups using the same statistical tests as in the previous section
4 Description of the main causes of error with percentage percentages for each of the identified causes
5 Evaluation of the factors associated with an invalid RPR using the statistical tests previously carried out and estimating the corresponding OR and the six 95 confidence intervals 95 CI using bivariate and multivariate logistic regression to adjust for possible risk factors confused
6 Assessment of secondary objects In all statistical analyses a statistical significance level of 005 will be considered
1 The use of a video for the correct performance of home respiratory polygraphy RP reduces the number of errors derived from poor placement of the polygraph
2 The degree of satisfaction of telematic instruction will be higher than that of in-person instruction
3 Telematic instruction will achieve a reduction in care time allocated to instruction for the nursing staff of the Pneumology Day Hospital
Objectives
Main objective
Compare the number of errors in the RP record derived from poor placement of the polygraph between an in-person nursing instruction and a telematic instruction using a video
Secondary objectives
Compare the number of total errors in the RP record between an in-person nursing instruction and a telematic instruction using a popular video
Compare the level of patient satisfaction between in-person nursing instruction and telematic instruction using a video
Compare the time invested in nursing at the Pneumology Day Hospital in the delivery and instruction of polygraph use between in-person instruction and telematic instruction
Study design
Open randomized clinica trial with two arms of intervention instruction in the functioning of the respiratory polygraph according to usual clinical practice and instruction in audiovisual media
Study population Patients with suspected Obstructive sleep apnea OSA who have been indicated for performing a home respiratory polygraphy for the first time
Study exhibition Consecutive patients with OSA who come to the Pneumology Service for the collection of a respiratory polygraph for the performance of a home PR for the first time Recruitment is made at the time you go to collect the respiratory polygraph if you decide to participate in the study after signing the informed consent and checking the inclusion and exclusion criteria At that moment randomization will be made and they will be assigned to one of the two intervention groups
Statistical analysis
The data will be registered in an electronic data base in a dissociated manner so that the analyzers will not be able to connect the identity of the persons participating in the study The database will be stored in the CSdM information system along with standard security measures The analysis plan includes
1 Description of the main characteristics of the study sample age gender participation of a third person number of views etc including values and typical deviations for numerical variables and percentages for categorical variables
2 Assessment of the homogeneity andor comparability of the two study groups The categorical variables are compared using the Khi al quadrat test or the Fisher exact test and the numerical variables with the T-Student test or the Man Whitney U test
3 Comparison of the main results measures percentage of valid PRs number of errors satisfaction investment times between the two study groups using the same statistical tests as in the previous section
4 Description of the main causes of error with percentage percentages for each of the identified causes
5 Evaluation of the factors associated with an invalid RPR using the statistical tests previously carried out and estimating the corresponding OR and the six 95 confidence intervals 95 CI using bivariate and multivariate logistic regression to adjust for possible risk factors confused
6 Assessment of secondary objects In all statistical analyses a statistical significance level of 005 will be considered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None