Effectiveness of Telematic Instruction to Patients in the Correct Performance of Respiratory Polygraphy at Home

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea of Adult
• Intervention / Treatment: Other: Video-assisted training; Other: Nurse training

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 and/or 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 0.05 will be considered.

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Mataró, Barcelona, Spain, 08304
      • Mateu Serra-Prat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients above 18 years of age with a clinical suspicion of obstructive sleep apnea who had never undergone respiratory polygraphy

Exclusion Criteria:

• physical, mental or instrumental impairment for video-assisted training;
• the absence of a third person who could collaborate in the setup of the RP;
• the absence of internet connections;
• misunderstanding of Catalan or Spanish languages

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video-assisted training; Patients received a QR code and a link for access to a YouTube video recorded where the process of setting up the respiratory polygraph was explained.	Other: Video-assisted training; Patients received a QR code and a link for access to a YouTube video recorded to this effect where the process of setting up the respiratory polygraph was explained. The contents of the video were the same as those in the face-to-face instructions. The visualization of the video was at home, and it could be viewed as many times as necessary.
Placebo Comparator: Nurse training; A trained nurse with long experience in home sleep studies explained the setup of the Respiratory Polygraph.	Other: Nurse training; A trained nurse with long experience in home sleep studies explained the setup of the respiratory polygraph. At the end of the intervention doubts about the procedure were addressed. Patients did not have access to the video.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of valid respiratory polygraphies	Number of studies without recording errors	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal care time used in the training of the procedure	Minutes of caregiver's time spent in the instruction	1 day
Satisfaction with the instruction	Satisfaction of the patients with the instruction measured by an analogic visual scale (0-10)	1 day

Collaborators and Investigators

• Sponsor: Consorci Sanitari del Maresme
• Investigators: Principal Investigator: Alejandro Robles, MD PhD, Hospital de Mataró

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 13/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No