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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04196699
• Other study ID #: Feasibility study (Neith)
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: June 28, 2020

Study information

• Verified date: December 2019
• Source: University of Paris 13
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 28, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Paris 13	Hotel Dieu Hospital, Lebanese University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	Based on "Pre-Referral intervention team inventory" we have created our own evaluation grid composed of 9 questions. Answers ranged between strongly agree to strongly disagree.	2 month
Primary	Adoption	Based on "adoption of information technology innovation" we have created our own evaluation grid composed of 5 questions. Patient must choose one of the proposed answers that best suits him/her.	2 month
Primary	Adequacy	Based on "Parenting strategies questionnaire" we have created our own qualitative evaluation grid composed of three questions. the patient must assign a score to each question that varies between 0 and 10.	2 month
Primary	Fidelity	Fidelity will be assessed by comparing the protocol of the intervention with what will be done in the field.	2 month
Primary	Cost	Based on "Utilization and Cost Questionnaire" we have created our own qualitative evaluation grid composed of 4 questions.	2 month
Primary	Coverage	Based on "levels of institutionalization". it is composed of 15 multiple-choice questions. Based on the average of the responses, the score will range from a low to high level of institutionalization.	2 month
Secondary	Impact on quality of life	We will use the COPD assessment test (CAT) to evaluate the quality of life of participants.; CAT is composed of eight questions measured on a 5-point scale, with a score ranging from 0 to 40. Highest scores indicate a higher impact of COPD on patients' quality of life.	3 month
Secondary	Rehospitalization rate	The hospital register of each participant will be consulted to collect and evaluate the number of hospitalizations during the year preceding the intervention and during the intervention	3 month
Secondary	Emergency visit	The hospital register of each participant will be consulted to collect and evaluate the emergency room visits during the year preceding the intervention and during the intervention	3 month
Secondary	Respiratory health status	COPD clinical questionnaire (CCQ). It consists of 10 questions in 3 domains (symptoms, functional state, and mental state). All scores ranged from 0 to 6, and the final score is the mean of the sum of all items, with a higher score indicating a lower health status.	3 month
Secondary	Anxiety	"Hospital Anxiety and Depression" (HAD). It includes 14 rated items from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), resulting in two scores (maximum score of each score = 21).	3 month