J45
Conditions
Interventions
Group 1: The intervention group receives an 8-week comprehensive lifestyle modification programme in addition to standard care. All patients including the control group follow a standard symptomatic t
Sponsors
Faculty of Pharmacy in Hradec Kralove
Charles University in Prague
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All patients fulfilled the following inclusion criteria: 1. Patients had to be of age 18 and older, and 2. had an established diagnosis of mild-to-severe asthma for at least 6 months partially controlled or uncontrolled by symptomatic treatment based on GINA guidelines.
Exclusion criteria
Exclusion criteria: Exclusion criteria were: occupational asthma, oral or systematic corticosteroid use during the last 6 months, concomitant lung disease or a chronic unstable condition, use of any complementary therapies, use of specific allergen immunotherapy, current or past participation in an integrative self-management programme, current nicotine use, and pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Asthma quality of life (AQLQ): A higher score indicated better quality of life with a minimal important difference of 0.5=MID being considered a clinically significant change in asthma quality of life. 2. Asthma control (ACQ, ACT): ACQ - A well-controlled asthma = a mean score of 0.75=ACQ. Uncontrolled asthma= a mean score of ACQ=1.5. ACT - Well-controlled = a total score of 20=. Poorly controlled asthma = a total score of =15. Outcomes (No. 1-2 ) are measured at baseline, at the end of the eight-week programme and a 4-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. General burden of asthma symptoms (Visual analogue scale – VAS): A lower score indicated lower burden of asthma symptoms. 2. Rescue medication reduction: reliever use 3. Lung function: peak expiratory flow (PEFR), forced expiratory volume (FEV1), forced vital capacity (FVC), and FEV1/FVC ratio 4. Perceived Stress Scale (PSS): A lower score indicated lower stress level. 5. The psychopathology profile (Symptom Check-list-90 - SCL-90): A lower score indicated psychopatology symptoms. 6. Subjective Quality of Life (SQUALA): A lower score indicated better quality of life. 7. Self-esteem scale (RSES): A lower score indicated a higher self-esteem. 8. Positive attitudes towards life subscale of the Berner Questionnaire for Well-being (BFW): A lower score indicated more positive attitudes. 9. Spirituality: Personal meaning profile (PMP), Ecospirituality subscale of the Prague spiritual questionnaire (PSQ): A lower score indicated higher spirituality. 10. Health care utilisation (scheduled and unscheduled primary care consultations, emergency visits, intensive care unit, hospital admissions, severe asthma exacerbations) 11. Common cold episodes (a sore throat, cough, sneezing, runny and stuffed nose, and/or systemic symptoms) Outcomes (No. 1-11) are measured at baseline, at the end of the eight-week programme and a 4-month follow-up. Rescue medication use is recorded daily in patients’ diaries (data were cross-checked by data retrieval from the outpatient database of patient medication records). Medication, health care service use and common cold episodes were collected using a patient questionnaire and were cross-checked by data retrieval from the outpatient database of patient medication records. | — |
Countries
Czechia
Contacts
Public ContactJitka Pokladnikova
Faculty of Pharmacy in Hradec Kralove Charles University in Prague
Outcome results
None listed