Chronic Obstructive Pulmonary DiseaseNCT04196699
Evaluating the Feasibility, Acceptability and Pre Testing the Impact of a Self-management and Tele Monitoring Program for COPD Patients in Lebanon
A study testing self-management program in people with Chronic Obstructive Pulmonary Disease, run by University of Paris 13.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- self-management program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2020to 28 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients diagnosed with lung cancer
- Patients who have cognitive problems related to memory loss or speech disorders that would not allow a constructive exchange
About this study
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
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- self-management program
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-management programBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 month
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.
Measured: 2 month
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.
Measured: 2 month
Fidelity
Fidelity will be assessed by comparing the protocol of the intervention with what will be done in the field.
Measured: 2 month
Cost
Based on "Utilization and Cost Questionnaire" we have created our own qualitative evaluation grid composed of 4 questions.
Measured: 2 month
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.
Measured: 2 month
Secondary outcomes (5)
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.
Measured: 3 month
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
Measured: 3 month
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
Measured: 3 month
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.
Measured: 3 month
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).
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start10 Jan 2020 (estimated)
- Primary completion28 May 2020 (estimated)
- Study completion28 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Paris 13
- Sponsor type
- University, hospital or other
- Collaborators
- Lebanese University, Hotel Dieu Hospital
- Responsible party
- Principal investigator, Rita Nohra, University of Paris 13
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196699
- Sponsor's protocol ID
- Feasibility study (Neith)
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04196699
- Acronym / sponsor ID
- Feasibility study (Neith)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Paris 13University, hospital or other
- Collaborators
- Lebanese University, Hotel Dieu Hospital
- Study start
- 10 Jan 2020 (estimated)
- Primary completion
- 28 May 2020 (estimated)
- Study completion
- 28 Jun 2020 (estimated)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients diagnosed with lung cancer
- Patients who have cognitive problems related to memory loss or speech disorders that would not allow a constructive exchange
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-management programOur 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. | Behavioural | – |
Primary outcome
Acceptability
Time frame: 2 month
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
Time frame: 2 month
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
Time frame: 2 month
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
Time frame: 2 month
Fidelity will be assessed by comparing the protocol of the intervention with what will be done in the field.
Cost
Time frame: 2 month
Based on "Utilization and Cost Questionnaire" we have created our own qualitative evaluation grid composed of 4 questions.
Coverage
Time frame: 2 month
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.
5 secondary outcomes
Impact on quality of life
Time frame: 3 month
Rehospitalization rate
Time frame: 3 month
Emergency visit
Time frame: 3 month
Respiratory health status
Time frame: 3 month
Anxiety
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing self-management program in people with Chronic Obstructive Pulmonary Disease, run by University of Paris 13.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: 2 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.