Evaluating the Feasibility, Acceptability and Pre Testing the Impact of a Self-management and Tele Monitoring Program for COPD Patients in Lebanon

NCT ID: NCT04196699

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2020-06-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Chronic obstructive pulmonary disease (COPD) has a significant impact on quality of life and is costly to the health care system. It has been demonstrated that a self-management program improves quality of life, but programs are not universally available and telehealth interventions can provide home-based support, but have mixed results.

The aims of this study are to (1) assess the feasibility and acceptability of a 6 weeks' educational program related to self-management with remote monitoring for Lebanese COPD patients; (2) pre-test its impact on quality of life, emergency visits, and rate of rehospitalization, and (3) to make recommendations for a future randomized trial.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study aims to evaluate the feasibility, acceptability and pre-test the impact of a nursing consultation and tele-monitoring in Lebanon. It will be conducted at the Hôtel-Dieu de France (HDF) hospital, one of the largest university hospitals in Beirut, and will use quantitative and qualitative methods in pre- and post-intervention to collect data over a period of 3 months. Data will be collected by two researchers. A consent form will be signed by each participant prior to the intervention. Patients will be informed about the purpose of the study, the course of the intervention, and the freedom to withdraw from the study at any time. Their consent for the video recording will also be taken.

This study is the first to evaluate the application of telehealth to optimize COPD management in Lebanon. The results of this study will provide evidence regarding the efficacy and feasibility of this approach for Lebanese patients with moderate to severe COPD.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

self-management program

Our intervention will be based on the following framework and will consist of 3 phases :

Phase I: At the end of a medical consultation, the doctor will offer the patient the opportunity to benefit from a nursing consultation and remote monitoring to better manage his COPD. A nursing consultation will be scheduled during which the nurse will explain the procedure, obtain the written consent of the patient, and develop an educational diagnosis with the participation of the patient.

Phase II: During the next six weeks education sessions will be provide to the participants and a telephone number will be available in case of emergency and for any additional information.

Phase III: A final consultation will be scheduled at the nurse office to evaluate the patient's achievements and modify his/her educational assessment. A telephone follow-up will be conducted after one month to assess the maintenance of learning.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult,18 years of age or older
* Male or female
* Outpatient
* With moderate (GOLD 2) or severe (Gold 3) COPD.
* Cognitively capable, with an adequate health status to participate in the study according to the clinical consensus between nurses and physicians.

Exclusion Criteria

* Patients diagnosed with lung cancer
* Patients who have cognitive problems related to memory loss or speech disorders that would not allow a constructive exchange
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lebanese University

OTHER

Sponsor Role collaborator

Hotel Dieu Hospital

OTHER

Sponsor Role collaborator

University of Paris 13

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rita Nohra

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Feasibility study (Neith)

Identifier Type: -

Identifier Source: org_study_id