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Clinical Trials/CTRI/2022/11/047068
CTRI/2022/11/047068
Not yet recruiting
未知

Effect of digital (mHealth) and paper-based self-management educational interventions on quality of life of patients with common chronic respiratory diseases (bronchial asthma and chronic obstructive pulmonary disease): A mixed-methods pragmatic, randomized controlled trial

Science and Engineering Research Board (SERB)0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecifiedHealth Condition 2: J452- Mild intermittent asthmaHealth Condition 3: J453- Mild persistent asthmaHealth Condition 4: J454- Moderate persistent asthmaHealth Condition 5: J459- Other and unspecified asthmaHealth Condition 6: J455- Severe persistent asthma
Sponsor
Science and Engineering Research Board (SERB)
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Science and Engineering Research Board (SERB)

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria for patients with COPD:
  • (1\) Men and women aged \<65 years with mild, moderate or severe COPD as per GOLD criteria;
  • (2\) Resident of Chandigarh Tricity or Ambala district;
  • (3\) Have basic digital literacy and have access to Android smart phones with internet connection;
  • (4\) Can read and write English, Hindi or Punjabi;
  • (5\) Consent to participate in the study.
  • Inclusion criteria for patients with asthma:
  • (1\) Age 18\-65 years and both sex with bronchial asthma;
  • (2\) Resident of Chandigarh Tricity or Ambala district;
  • (3\) Can read and write English, Hindi or Punjabi and have basic digital literacy;

Exclusion Criteria

  • Exclusion criteria for patients with COPD:
  • (1\) Patients with coexisting non\-COPD pulmonary conditions (e.g., lung cancer, sarcoidosis, and others);
  • (2\) Prior lung\-volume reduction surgery and/or lung transplant;
  • (3\) Long\-term supplemental oxygen \>\=12h/day;
  • (4\) \>6 weeks of oral corticosteroids;
  • (5\) Serious or uncontrolled comorbidities likely to interfere with the study.
  • Exclusion criteria for patients with asthma:
  • (1\) Severe refractory asthma (defined as difficult to control asthma i.e., on high intensity treatment and uncontrolled asthma despite good adherence (\>\=80% of prescribed inhaled corticosteroids) to prescription and good inhalation technique);
  • (2\) Presence of any active lung disease other than asthma (e.g., COPD, lung cancer, sarcoidosis, active tuberculosis, chronic pulmonary aspergillosis, bronchiectasis, allergic broncho\-pulmonary aspergillosis, interstitial lung disease) or underwent lung reduction or related surgical interventions;
  • (3\) Long\-term supplemental oxygen or home NIV as these patients generally have end\-stage lung disease and may not respond to our interventions;

Outcomes

Primary Outcomes

Not specified

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