Condition category
Respiratory
Date applied
23/03/2010
Date assigned
28/04/2010
Last edited
13/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francisca Leiva Fernández

ORCID ID

Contact details

Unidad Docente Medicina Familiar y Comunitaria
Distrito Sanitario Málaga
Plaza Hospital Civil s/n Pabellón 6 2ª planta
Málaga
29009
Spain
+34 951 29 03 10
francisca.leiva.sspa@juntadeandalucia.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EC07/90654

Study information

Scientific title

Efficacy and safety of a multifactorial intervention to improve treatment adherence in patients with chronic obstructive pulmonary disease (COPD)

Acronym

ICEPOC

Study hypothesis

A multifactorial educational intervention (information about chronic obstructive pulmonary disease [COPD], doses reminder, development of inhalation technique skills and audiovisual support) in patients with COPD prescribed fixed daily doses of inhaled treatment, with a follow up period of 1 year and two reinforcement visits (3 and 6 month after intervention) increases at least 25% the treatment adherence in the intervention group versus the control group.

Ethics approval

1. Ethical Committee of Distrito Sanitario Málaga approved on the 1st March 2007
2. Ethical Committee of Distrito Sanitario Axarquía approved on the 13th May 2008
3. Committee of Clinical Trials of Hospital Cínico Universitario Virgen de la Victoria approved on the 30th November 2007

The study protocol was reviewed by Spanish Medicine Agency and Sanitary products.

Study design

Multicentre randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

Subjects will be divided randomly into two groups, using the block randomisation technique: a control group and an intervention group. All patients will attend the same number of appointments. The intervention group will have an educational intervention.

The intervention consists in three parts that include the most relevant aspects related to the treatment adherence in patients with COPD:

Part 1: Motivational aspects to improve the adherence -
Why the recommended therapeutic regimen is not accomplished, to emphasize on the motivational aspects that could improve the treatment adherence in the next follow up visits. This intervention session will be recorded with a patient formal consent for later analysis.

Part 2: Cognitive aspects related with treatment adherence -
The intervention group received information about the disease so they can be more confident and more conscious about the importance of the daily treatment intake.

Part 3: Skills developing -
Inhaled technique training. The intervention group was trained about how they use their inhalers, why a good technique is important and practice the proper technique with placebo inhalers.

Groups will be formed from 6 to 9 patients, a proper number according to the bibliography for this type of intervention. The session time lasts about 2 hours including the patient's reception, the material distribution, the mentioned contents and the farewell. All interventions will be conducted by two professionals specially trained in motivational techniques and in the use of inhaler devices. Audiovisual and written material will be used in parts 2 and 3 of the intenvention (leaflet with the most relevant disease aspects and scheme about inhalation technique).

The educational intervention has a duration of 1 - 2 hours, depending on the group of patients. The follow-up period is one year with 3 appointments to emphasize on the motivational aspects that could improve treatment adherence. The duration of these appointments depends on the patient’s adherence and skills. The measurement of duration of visits will be a result of our study.

In the control arm the participants have the same follow-up period and visits without the intervention.

Visit scheme:

Intervention group:
Visit 0 (inclusion): all the study data (primary, secondary and independent variables) will be recorded and the treatment adherence will be measured
pVisit 1 pre-adherence: It will take place one month before visit 1 in order to measure its compliance
Visit 1: It will take place 3 months after the intervention. Primary outcome will be measured and encouraging work about inhalers techniques and motivational aspects related to adherence will be individually applied.
pVisit 2 pre-adherence: It will take place 1 month before visit 2 in order to measure its adherence
Visit 2: It will take place 6 months after the intervention. Primary outcome will be measured and encouraging work about inhalers techniques and motivational aspects related to adherence will be individually applied.
pVisit 3 pre-adherence: It will take place 1 month before visit 3 in order to measure its adherence
Visit 3: It will take place after 1 year follow up. It will involve a whole visit in which all the study data will be measured.

Control group:
Visit 0 (inclusion): all the study data (primary, secondary and independent variables) will be recorded and the treatment adherence will be measured
pVisit 1 pre-adherence: It will take place one month before visit 1 in order to measure its compliance
Visit 1: It will take place 3 months after the intervention. Primary outcome will be measured.
pVisit 2 pre-adherence: It will take place 1 month before visit 2 in order to measure its adherence
Visit 2: It will take place 6 months after the intervention. Primary outcome will be measured.
pVisit 3 pre-adherence: It will take place 1 month before visit 3 in order to measure its adherence
Visit 3: It will take place after 1 year follow up. It will involve a whole visit in which all the study data will be measured.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Treatment adherence evaluated using dose or pill recount, measured at the three visits of the trial.

Secondary outcome measures

Measured at start and end of study:
1. Functional status (spirometry)
2. Quality of life, measured using the Spanish version of the St George’s Respiratory Questionnaire and the specifically developed SeguiEPOC Questionnaire

Overall trial start date

01/09/2008

Overall trial end date

30/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Confirmed COPD diagnose by spirometry (Spanish Society of Pulmonology and Thoracic Surgery [SEPAR] guidelines)
2. Belong to the selected Primary Care Centres in Malaga area
3. Prescription of fixed daily doses of inhaled treatment
4. Accepted to participate in the study and gives informed consent
5. Aged greater than or equal to 18 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

Participant exclusion criteria

1. Diagnosis of other respiratory conditions which are not included in the COPD definition
2. Cognitive impairment problems

Recruitment start date

01/09/2008

Recruitment end date

30/09/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Unidad Docente Medicina Familiar y Comunitaria
Málaga
29009
Spain

Sponsor information

Organisation

Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)

Sponsor details

Health Research Fund
Ministry of Science and Innovation
C/ Sinesio Delgado 6
Madrid
28029
Spain
+34 918 22 21 00
oficina.informacion@isciii.es

Sponsor type

Government

Website

http://www.isciii.es/htdocs/index.jsp

Funders

Funder type

Government

Funder name

Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) - Health Research Fund, Ministry of Science and Innovation (MICINN)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24762026

Publication citations

Additional files

Editorial Notes