Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201609001793108 Date of Approval: 24/09/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Asthma action plan
Official scientific title Asthma action plan for proactive bronchial asthma self-management in adults: a randomized controlled trial
Brief summary describing the background and objectives of the trial Background: Written personalized asthma action plans are recommended as part of patient education and self management. the Objective of the RCT is to enable asthmatic adults to proactively self- manage bronchial asthma and sustain asthma quiescent status through utilization of the AAP and to establish a feasible asthmatic/care taker ¿ health care provider communication.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied bronchial asthma,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/08/2015
Actual trial start date
Anticipated date of last follow up 31/01/2016
Actual Last follow-up date 31/01/2016
Anticipated target sample size (number of participants) 320
Actual target sample size (number of participants) 320
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
nil known institutional review board and ethics committeHigh Institute of Public Health, Alexandria University
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard care daily 6 months Standard asthma care 160 Active-Treatment of Control Group
Experimental Group Asthma action plan Daily 6 months A written description of some instrutionc to enable asthmatic adults to proactively self-manage bronchial asthma and sustain asthma quiescent status 160
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
asthmatic adults > 18 year both gender moderate to sever asthma admission in last 12 months none 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/04/2015 Ethics committee of High Institute of Public Health
Ethics Committee Address
Street address City Postal code Country
165 El Horreya Road Alexandria 21561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome proactively self- manage bronchial asthma and sustain asthma quiescent status every months for 6 months
Primary Outcome improved patient doctor communication monthly for 6 months
Primary Outcome decrease number of hospitalizations, emergency department admissions and intensive care admission monthly for 6 months
Primary Outcome avoid asthma triggers monthly for 6 months
Primary Outcome decrease days of sick leaves and absenteesim monthly for 6 months
Primary Outcome decrease cost of treatment monthly for 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gamal Abdel Nasser Hospital 164 El Horreya Road, Alexandria 21561 Egypt
High Institute of Public Health, Alexandria University 165 El Horreya Road, Alexandria 21561 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
none; self funded 164 El Horreya Road, Alexandria 21561 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor self funded by the auothors 165 El Horreya Road, Alexandria 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
none
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ekram Abd El-Wahab ekramwassim@mail.com 00201110456072 165 El Horreya Road
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Associate profesor, , High Institute of Public Health, Alexandria University
Role Name Email Phone Street address
Public Enquiries Ekram Abd El-Whab ekramwassim@mail.com 0020111456072 165 El Horreya Road
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Associate profesor, , High Institute of Public Health, Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Ekram Abd El-Wahab ekramwassim@mail.com 00201110456072 165 El Horreya Road
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Associate profesor, , High Institute of Public Health, Alexandria University
REPORTING
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