Educational intervention to improve the treatment adherence in patients with chronic obstructive pulmonary disease (COPD)

ISRCTN	ISRCTN18841601
DOI	https://doi.org/10.1186/ISRCTN18841601
Secondary identifying numbers	EC07/90654

Submission date: 23/03/2010
Registration date: 28/04/2010
Last edited: 13/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Francisca Leiva Fernández
Scientific

Unidad Docente Medicina Familiar y Comunitaria
Distrito Sanitario Málaga
Plaza Hospital Civil s/n Pabellón 6 2ª planta
Málaga
29009
Spain

Phone	+34 951 29 03 10
Email	francisca.leiva.sspa@juntadeandalucia.es

Study information

Study design	Multicentre randomised controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Efficacy and safety of a multifactorial intervention to improve treatment adherence in patients with chronic obstructive pulmonary disease (COPD)
Study acronym	ICEPOC
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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 patients 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
Primary outcome measure	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 Georges Respiratory Questionnaire and the specifically developed SeguiEPOC Questionnaire
Overall study start date	01/09/2008
Completion date	30/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	140
Key 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
Key exclusion criteria	1. Diagnosis of other respiratory conditions which are not included in the COPD definition 2. Cognitive impairment problems
Date of first enrolment	01/09/2008
Date of final enrolment	30/09/2010

Locations

Countries of recruitment

Spain

Study participating centre

Unidad Docente Medicina Familiar y Comunitaria

Málaga
29009
Spain

Sponsor information

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

Health Research Fund
Ministry of Science and Innovation
C/ Sinesio Delgado 6
Madrid
28029
Spain

Phone	+34 918 22 21 00
Email	oficina.informacion@isciii.es
Website	http://www.isciii.es/htdocs/index.jsp
"ROR"	https://ror.org/00ca2c886

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/04/2014		Yes	No