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

NCT04196699 | Unknown

• 1 other identifier: Feasibility study (Neith)
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• Fidelity

  Fidelity will be assessed by comparing the protocol of the intervention with what will be done in the field.

  2 month

• Cost

  Based on "Utilization and Cost Questionnaire" we have created our own qualitative evaluation grid composed of 4 questions.

  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.

  2 month

Secondary Outcomes (5)

• Impact on quality of life

  3 month

• Rehospitalization rate

  3 month

• Emergency visit

  3 month

• Respiratory health status

  3 month

• Anxiety

  3 month

Interventions

self-management program BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Paris 13: lead
• Lebanese University: collaborator
• Hotel Dieu Hospital: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 12, 2019
• Study Start: January 10, 2020
• Primary Completion: May 28, 2020
• Study Completion: June 28, 2020
• Last Updated: December 12, 2019

Record last verified: 2019-12