Clinical trial NCT04196699: Evaluating the Feasibility, Acceptability and Pre Testing the Impact of a Self-management and Tele Monitoring Program for COPD Patients in Lebanon
Official title: Evaluating the Feasibility, Acceptability and Pre Testing the Impact of a Self-management and Tele Monitoring Program for COPD Patients in Lebanon: Protocol for a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Paris 13
Sponsor class: OTHER
Collaborators: name: Lebanese University
name: Hotel Dieu Hospital
First posted: 2019-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability
timeFrame: 2 month
measure: Adoption
timeFrame: 2 month
measure: Adequacy
timeFrame: 2 month
measure: Fidelity
timeFrame: 2 month
measure: Cost
timeFrame: 2 month
measure: Coverage
timeFrame: 2 month
Secondary outcomes:
measure: Impact on quality of life
timeFrame: 3 month
measure: Rehospitalization rate
timeFrame: 3 month
measure: Emergency visit
timeFrame: 3 month
measure: Respiratory health status
timeFrame: 3 month
measure: Anxiety
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
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