Trial document





This trial has been registered retrospectively.
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  DRKS00003535

Trial Description

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Title

The effectiveness of a comprehensive lifestyle modification programme for asthma patients (ETHICO study): a randomized controlled trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Current standard symptomatic treatment doesn't control for all the factors, including patients’ psychosocial status, that play a role in asthma development and progression. The aim of the study is to evaluate the long-term effectiveness of an adjuvant 8-week comprehensive lifestyle modification programme for asthma over a 6-month period.
Patients are recruited from an out-patient hospital, a clinic, and hospital and community pharmacies.

Hypothesis: A comprehensive lifestyle modification programme for primary care asthma patients will result in reduced asthma symptoms/rescue medication use, better asthma quality of life, better asthma control, improved lung function, reduced level of stress, improved psychosocial and spiritual status compared to standard care.

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Brief Summary in Scientific Language

Current standard symptomatic treatment doesn't control for all the factors, including patients’ psychosocial status, that play a role in asthma ethiopatogenesis. The aim of the study is to evaluate the effectiveness of an adjuvant 8-week lifestyle modification programme for asthma compared to standard care in patients with bronchial asthma over a 6-month period.

Hypothesis: A comprehensive lifestyle modification programme for primary care asthma patients will result in reduced asthma symptoms/rescue medication use, better asthma quality of life, better asthma control, improved lung function, reduced level of stress, improved psychosocial and spiritual status compared to standard care.

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Organizational Data

  •   DRKS00003535
  •   2012/02/10
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  •   yes
  •   Approved
  •   200903S10P , Ethics board: Etická komise Fakultní nemocnice Hradec Králové FN Hradec Králové Sokolská 581 500 05 Hradec Králové Czech Republic
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Secondary IDs

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Health Condition or Problem studied

  •   J45 -  Asthma
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Interventions/Observational Groups

  •   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 treatment according to the GINA guidelines. All patients are followed-up for 4 months after the end of the intervention. Outcomes are measured at baseline, at the end of the eight-week programme and a 4-month follow-up. The eight week self-management programme involved four group meetings on lifestyle changes (1.5 hrs per session: asthma specific diet, yogic postures, stress management training) and four individual sessions on psychotherapy counseling (1 hr per session).
  •   The attention-placebo control group receives individual conventional asthma education supplemented with Pocket guide for asthma management. All patients including the control group follow a standard symptomatic treatment according to the GINA guidelines. All patients are followed-up for 4 months after the end of the intervention. Outcomes are measured at baseline, at the end of the eight-week programme and a 4-month follow-up.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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.

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Countries of Recruitment

  •   Czech Republic
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Locations of Recruitment

  • Medical Center 
  • Doctor's Practice 
  • other 
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Recruitment

  •   2009/05/01
  •   Actual
  •   72
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

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    • Faculty of Pharmacy in Hradec Kralove Charles University in Prague
    • Heyrovskeho 1203
    • 500 05  Hradec Kralove
    • Czech Republic
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    • Faculty of Pharmacy in Hradec Kralove Charles University in Prague
    • Ms.  PharmDr., Ph.D.  Jitka  Pokladnikova 
    • Heyrovskeho 1203
    • 500 05  Hradec Kralove
    • Czech Republic
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    • Faculty of Pharmacy in Hradec Kralove Charles University in Prague
    • Ms.  PharmDr., Ph.D.  Jitka  Pokladnikova 
    • Heyrovskeho 1203
    • 500 05  Hradec Kralove
    • Czech Republic
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Sources of Monetary or Material Support

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    • Olga Havlova Foundation - Sasakawa Asthma Fund
    • Senovážné náměstí 2
    • 11121  Prague 1
    • Czech Republic
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    • Josef Pliva Foundation
    • náměstí Míru 80
    • 56802  Svitavy
    • Czech Republic
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Status

  •   Recruiting complete, follow-up complete
  •   2010/03/15
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Trial Publications, Results and other Documents

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