Evaluating the Feasibility, Acceptability and Pre Testing the Impact of a Self-management and Tele Monitoring Program for COPD Patients in Lebanon
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
self-management program
Sponsored by
About this trial
This is an interventional other trial for Chronic Obstructive Pulmonary Disease
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
Sites / Locations
Outcomes
Primary Outcome Measures
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.
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.
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.
Fidelity
Fidelity will be assessed by comparing the protocol of the intervention with what will be done in the field.
Cost
Based on "Utilization and Cost Questionnaire" we have created our own qualitative evaluation grid composed of 4 questions.
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.
Secondary Outcome Measures
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.
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
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
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.
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).
Full Information
NCT ID
NCT04196699
First Posted
December 4, 2019
Last Updated
December 11, 2019
Sponsor
University of Paris 13
Collaborators
Lebanese University, Hotel Dieu Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04196699
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2020 (Anticipated)
Primary Completion Date
May 28, 2020 (Anticipated)
Study Completion Date
June 28, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Paris 13
Collaborators
Lebanese University, Hotel Dieu Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
self-management program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability
Description
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.
Time Frame
2 month
Title
Adoption
Description
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.
Time Frame
2 month
Title
Adequacy
Description
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.
Time Frame
2 month
Title
Fidelity
Description
Fidelity will be assessed by comparing the protocol of the intervention with what will be done in the field.
Time Frame
2 month
Title
Cost
Description
Based on "Utilization and Cost Questionnaire" we have created our own qualitative evaluation grid composed of 4 questions.
Time Frame
2 month
Title
Coverage
Description
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.
Time Frame
2 month
Secondary Outcome Measure Information:
Title
Impact on quality of life
Description
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.
Time Frame
3 month
Title
Rehospitalization rate
Description
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
Time Frame
3 month
Title
Emergency visit
Description
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
Time Frame
3 month
Title
Respiratory health status
Description
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.
Time Frame
3 month
Title
Anxiety
Description
"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).
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Feasibility, Acceptability and Pre Testing the Impact of a Self-management and Tele Monitoring Program for COPD Patients in Lebanon
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