Trial Outcomes & Findings for Evaluation the Effectiveness of a Telemonitoring Program in a Cohort of COPD Patient With Frequent Readmissions (NCT NCT02528370)

Results Overview

The primary outcome of the program was to diminish the rate of hospitalizations for eCOPD. We defined an exacerbation as a sustained worsening of the participant's COPD symptoms from their usual stable state that was beyond normal day-to-day variations, and with a severity level that need hospital admission to be solved.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

197 participants

Primary outcome timeframe

two years

Results posted on

2021-02-16

Participant Flow

Participant milestones

Participant milestones
Measure	telEPOC The program consisted of: 1) Educational program about chronic obstructive pulmonary disease (COPD). This educational program was carried-out by a respiratory nurse in two 30-minute speeches to the patient and career, once at their inclusion in the program and again 1 year later. 2) Training in using the device (smart phone) that supported the telemonitoring. 3) Daily phone calls to make self-confident the patient during the first week. Afterwards the phone calls were established according to the capacity of the patient to manage on their own.	No telEPOC / Usual Care The control group follows the usual care protocol in our health system. That includes periodic control by their primary and respiratory specialist. They receive non-structured information/education about COPD and follow a programmed control agenda depending on the severity of the disease every 4-6 months. Generally speaking the differences between the two cohorts were the educational structured program and the telemonitoring control.
Overall Study STARTED	119	78
Overall Study COMPLETED	102	77
Overall Study NOT COMPLETED	17	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation the Effectiveness of a Telemonitoring Program in a Cohort of COPD Patient With Frequent Readmissions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	telEPOC n=119 Participants The program consisted of: 1) Educational program about COPD. This educational program was carried-out by a respiratory nurse in two 30-minute speeches to the patient and career, once at their inclusion in the program and again 1 year later. 2) Training in using the device (smart phone) that supported the telemonitoring. 3) Daily phone calls to make self-confident the patient during the first week. Afterwards the phone calls were established according to the capacity of the patient to manage on their own.	No telEPOC / Usual Care n=78 Participants The control group follows the usual care protocol in our health system. That includes periodic control by their primary and respiratory specialist. They receive non-structured information/education about COPD and follow a programmed control agenda depending on the severity of the disease every 4-6 months. Generally speaking the differences between the two cohorts were the educational structured program and the telemonitoring control.	Total n=197 Participants Total of all reporting groups
Age, Continuous	71.34 years STANDARD_DEVIATION 9.36 • n=93 Participants	70.1 years STANDARD_DEVIATION 7.5 • n=4 Participants	70.83 years STANDARD_DEVIATION 8.83 • n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	10 Participants n=4 Participants	26 Participants n=27 Participants
Sex: Female, Male Male	103 Participants n=93 Participants	68 Participants n=4 Participants	171 Participants n=27 Participants
Region of Enrollment Spain	119 Participants n=93 Participants	78 Participants n=4 Participants	197 Participants n=27 Participants
Body mass, airflow obstruction, dyspnea, and exercise capacity (BODE) index	4.3 units on a scale STANDARD_DEVIATION 2.5 • n=93 Participants	3.9 units on a scale STANDARD_DEVIATION 2.2 • n=4 Participants	4.1 units on a scale STANDARD_DEVIATION 2.4 • n=27 Participants

PRIMARY outcome

Timeframe: two years

The primary outcome of the program was to diminish the rate of hospitalizations for eCOPD. We defined an exacerbation as a sustained worsening of the participant's COPD symptoms from their usual stable state that was beyond normal day-to-day variations, and with a severity level that need hospital admission to be solved.

Outcome measures

Outcome measures
Measure	telEPOC n=119 Participants The program consisted of: 1) Educational program about COPD. This educational program was carried-out by a respiratory nurse in two 30-minute speeches to the patient and career, once at their inclusion in the program and again 1 year later. 2) Training in using the device (smart phone) that supported the telemonitoring. 3) Daily phone calls to make self-confident the patient during the first week. Afterwards the phone calls were established according to the capacity of the patient to manage on their own.	No telEPOC / Usual Care n=78 Participants The control group follows the usual care protocol in our health system. That includes periodic control by their primary and respiratory specialist. They receive non-structured information/education about COPD and follow a programmed control agenda depending on the severity of the disease every 4-6 months. Generally speaking the differences between the two cohorts were the educational structured program and the telemonitoring control.
Number of Hospitalizations for COPD Exacerbation (eCOPD)	1.1 number of hospital admissions Interval 0.7 to 1.5	2.8 number of hospital admissions Interval 2.2 to 3.4

Adverse Events

telEPOC

Serious events: 2 serious events

Other events: 0 other events

Deaths: 13 deaths

No telEPOC / Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 22 deaths

Serious adverse events

Serious adverse events
Measure	telEPOC n=119 participants at risk The program consisted of: 1) Educational program about COPD. This educational program was carried-out by a respiratory nurse in two 30-minute speeches to the patient and career, once at their inclusion in the program and again 1 year later. 2) Training in using the device (smart phone) that supported the telemonitoring. 3) Daily phone calls to make self-confident the patient during the first week. Afterwards the phone calls were established according to the capacity of the patient to manage on their own.	No telEPOC / Usual Care n=78 participants at risk The control group follows the usual care protocol in our health system. That includes periodic control by their primary and respiratory specialist. They receive non-structured information/education about COPD and follow a programmed control agenda depending on the severity of the disease every 4-6 months. Generally speaking the differences between the two cohorts were the educational structured program and the telemonitoring control.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	1.7% 2/119	0.00% 0/78

Other adverse events

Adverse event data not reported

Additional Information

Dr Cristobal Esteban

Hospital Galdakao-Usansolo

Phone: 0034 94 400 7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place