The role of the pharmacist in the team care of hospitalized patients with Chronic Brochitis or Emphysema

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-5bw2wt
• Date of registration: 01/05/2012
• Primary sponsor: Hospital de Clínicas de Porto Alegre - UFRGS - Porto Alegre, RS, Brazil
• Public title: The role of the pharmacist in the team care of hospitalized patients with Chronic Brochitis or Emphysema
• Scientific title: Pharmaceutical care Programme for inpatients with Chronic Obstructive Pulmonary Disease in a Tertiary Teaching Hospital in Southern Brazil - PHARBE: PHARmaceutical Care Programme for Inpatients with COPD in a Tertiary Teaching Hospital in Southern Brazil
• Date of first enrolment: 01/04/2012
• Target sample size: 150
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-5bw2wt/
• Study design: Open-label Randomized Controlled Clinical Trial with two parallel groups.

Countries of recruitment

Brazil

Contacts

• Name: Fernando Augusto Dias
• Affiliation: Universidade Federal do Rio Grande do Norte

• Name: Fernando Augusto Dias
• Affiliation: Universidade Federal do Rio Grande do Norte

Key inclusion & exclusion criteria

Inclusion criteria: Unhealed venous ulcer with at least eight weeks of duration
Ankle-brachial index equal or higher than 0,8
Without signs of venous ulcer infecction
Without previous diagnosis of connective tissue disease that may interfere in the healing process
Without contraindication for ultrasound use
Exclusion criteria: Wound infecction
Exclusion by patient request

Age minimum: 18Y
Age maximum: 90Y
Gender: -

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease
I83.0

I00-I99

Intervention(s)

75 patients will be randomized to control and 75 to intervention group.
Control Group- usual care provided by assistential team (pneumology or internal medicine service) without pharmacist participation.
Intervention Group - usual care plus pharmacist intervention by the pharmaceutical care Programme with the Dader Method adapted for hospitalized patients with COPD. A monthly monitoring will be conducted by telephone after discharge to complete 12 months of follow-up. The pharmacist will give couseling about selfcare, the disease and treatment adherence.

Primary Outcome(s)

Decrease in metalloproteinase (MMP) type 2 and 9 gene expression and/or activity in samples taken from lower limb venous ulcer exsudate. The MMPs expression will be assessed by real-time polymerase chain reaction and MMP and MMPs activity assessed by zymography. The biological sample will be collected before the first and after the last treatment using ultrasonic waves.

Decrease in the area of lower limb venous ulcer measured by an image editing software. The outline corresponding to the edges of lower limb venous ulcer will be digitized and its area will be measured in square centimeters before and after treatment using ultrasonic waves.

Secondary Outcome(s)

Pain intensity will be assessed by a visual analog scale. Pain intensity is expected to decrease or maintain pre-treatment levels.

Quality of life will be assessed by the quality of life questionnaires SF-36 and Venous Insufficiency Epidemiological and Economic Study (VEINES). The indexes of quality of life are expect to improve after the treatment.

Secondary ID(s)

CAAE 0163.0.051.294-09

Protocolo CEP/HUOL 376/09

Source(s) of Monetary Support

FAPERN - Fundação de apoio à pesquisa do estado do Rio Grande do Norte - Natal, RN, Brazil

CNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico - Brasilia, DF, Brazil

Secondary Sponsor(s)

Hospital Universitário Onofre Lopes - Natal, RN, Brazil