Mobile based observation of physiotherapy in children with cystic fibrosis

Completed

Conditions: Chronic obstructive pulmonary disease, unspecified,

Registration Number: CTRI/2021/09/036796

Lead Sponsor: AIIMS New Delhi

Brief Summary: | | |

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|Background

Objectives of the study

In this study we aim to establish whether the video based directly observed physiotherapy (VDOP) improves the adherence to airway clearance technique in children with cystic fibrosis.

Children with cystic fibrosis are on life long treatment with various medications and airway clearance therapy (ACT). The assessment of physiotherapy is generally done when the patient visits the CF specific center which has become difficult and inconvenient in the COVID era. Therefore, we want to see whether the directly observed physiotherapy via a smartphone/ internet based method improves the adherence to ACT i in children with cystic fibrosis of 1 month to 18 years of age.

**Primary objective**

To evaluate the adherence with correct technique for airway clearance therapy in children with cystic fibrosis of 1 month to 18 years of age using video based direct observation physiotherapy (VDOP) approach.

**Secondary objectives**

To evaluate

1. Improvement in lung function by spirometry parameters

2. Change in consistency of sputum

3. Number of exacerbations requiring antibiotic usage and/or hospitalization.

4. Clinical improvement

5. Quality of life by revised CF QOL score (Hindi Version)

|Justification for the conduct of the study

There is paucity of data about the assessment of airway clearance techniques in children with CF by mobile/ smartphone/ internet based methods. To assess the ACT properly, patient has to travel to the CF specific centres. This has become difficult and inconvenient in the COVID era. Mobile video based modality can assess the ACT by directly observing them either live or by videos at the patientsâ€™ home itself. Interaction between parents and health care providers without visiting health care facility will improve the adherence to therapy. Also, it can be corrected and a proper technique can be ensured. The physician and physiotherapist can connect to the parents and reinforce the importance of regular and appropriate physiotherapy. This will help in optimizing the management of CF, preventing the deterioration of lung function, improve quality of life and prevent long term morbidity.

|Methodology

**Sample size:** We expect an increase in adherence with correct technique to 67%, 30% of the previous study (effect size- 80%) and plan to enrol 92 children (46 in each arm) with cystic fibrosis to. As per available data we have a follow up of around 300-400 CF patients. We will review rate of enrolment in mid-term thesis evaluation and may modify sample size.

**Inclusion Criteria:** Children 1 month - 18 years of age diagnosed with Cystic fibrosis using Airway clearance therapy.

**Exclusion Criteria**

1. Non availability of a smart phone/ video capturing device.

2. Non availability of internet facility.

3. Unwilling to send videos for the study.

4. Children on home oxygen therapy.

**Methods:**

All children with diagnosis of cystic fibrosis attending the OPD/ Chest clinic/ ward will be screened for eligibility. Children meeting the inclusion criteria and no exclusion criteria will be considered for participation in the study. After taking an informed written consent from parent/ (legally authorized representative) LAR, children will be enrolled in the study. Patients will be divided into two groups: intervention group (VDOP) and control group (routine physiotherapy) after stratified block randomization in 1:1 ratio.

Details of clinical history and examination including anthropometry will be recorded in a predesigned performa. The baseline spirometry parameters, SK score, and revised CF QOL score will also be recorded and training for ACT will be given to all participants.

Patients in the intervention group will be asked to send daily videos of the ACT, initially for 7 days and then weekly for a total of 12 weeks. These videos will be assessed by two observers and the technique will be rated correct/ incorrect as per the checklist.

The other group will do physiotherapy as usual.

At the end of 12 weeks, following parameters will be assessed in both the groups.

1.     ACT technique will be assessed physically by 2 independent assessors. If there is any discrepancy a 3rd person will assess who will also be masked.

2.     Diary record check

3.     Inhaler count (ICS)

4.     Spirometry parameters -FeV1 FVC, FEV1/ FVC, PEF, FEF (25-75)

5.     Ease of sputum expectoration

6.     Number of exacerbations requiring antibiotic usage and/or hospitalization

7.     Shwachman-Kulczycki clinical score

8.     Revised CF- QOL score

**Duration of treatment**: The patients will receive standard treatment for their condition. **The videos will be observed for 12 weeks.**

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 92

Inclusion Criteria

Children with cystic fibrosis on airway clearance therapy Sample size: W e expect an increase in adherence with correct technique to 67%, 30% of the previous study (effect size- 80%) and plan to enrol 92 children (46 in each arm) with cystic fibrosis to. As per available data we have a follow up of around 300-400 CF patients. We will review rate of enrolment in mid-term thesis evaluation and may modify sample size . Inclusion Criteria: Children 1 month.
18 years of age diagnosed with Cystic fibrosis using Airway clearance therapy. Exclusion Criteria Non availability of a smart phone/ video capturing device. Non availability of internet facility. Unwilling to send videos for the study. Children on home oxygen therapy. Methods: All children with diagnosis of cystic fibrosis attending the OPD/ Chest clinic/ ward will be screened for eligibility . Children meeting the inclusion criteria and no exclusion criteria will be considered for participation in the study . After taking an informed written consent from parent/ (legally authorized representative) LAR, children will be enrolled in the study. Patients will be divided into two groups: intervention group (VDOP) and control group (routine physiotherapy) after stratified block randomization in 1:1 ratio. Details of clinical history and examination including anthropometry will be recorded in a predesigned performa . The baseline spirometry parameters, SK score, and revised CF QOL score will also be recorded and training for ACT will be given to all participants. Patients in the intervention group will be asked to send daily videos of the ACT, initially for 7 days and then weekly for a total of 12 weeks. These videos will be assessed by two observers and the technique will be rated correct/ incorrect as per the checklist. The other group will do physiotherapy as usual. At the end of 12 weeks, following parameters will be assessed in both the groups. 1. ACT technique will be assessed physically by 2 independent assessors. If there is any discrepancy a 3rd person will assess who will also be masked. 2. Diary record check 3. Inhaler count (ICS) 4. Spirometry parameters -FeV1 FVC, FEV1/ FVC, PEF, FEF (25-75) 5. Ease of sputum expectoration 6. Number of exacerbations requiring antibiotic usage and/or hospitalization 7. Shwachman-Kulczycki clinical score 8. Revised CF- QOL score Duration of treatment : The patients will receive standard treatment for their condition. The videos will be observed for 12 weeks.

Exclusion Criteria

1.Non availability of a smart phone/ video capturing device. 2.Non availability of internet facility. 3.Unwilling to send videos for the study. 4.Children on home oxygen therapy. Sample size: W e expect an increase in adherence with correct technique to 67%, 30% of the previous study (effect size- 80%) and plan to enrol 92 children (46 in each arm) with cystic fibrosis to. As per available data we have a follow up of around 300-400 CF patients. We will review rate of enrolment in mid-term thesis evaluation and may modify sample size . Inclusion Criteria: Children 1 month.
18 years of age diagnosed with Cystic fibrosis using Airway clearance therapy. Exclusion Criteria Non availability of a smart phone/ video capturing device. Non availability of internet facility. Unwilling to send videos for the study. Children on home oxygen therapy. Methods: All children with diagnosis of cystic fibrosis attending the OPD/ Chest clinic/ ward will be screened for eligibility . Children meeting the inclusion criteria and no exclusion criteria will be considered for participation in the study . After taking an informed written consent from parent/ (legally authorized representative) LAR, children will be enrolled in the study. Patients will be divided into two groups: intervention group (VDOP) and control group (routine physiotherapy) after stratified block randomization in 1:1 ratio. Details of clinical history and examination including anthropometry will be recorded in a predesigned performa . The baseline spirometry parameters, SK score, and revised CF QOL score will also be recorded and training for ACT will be given to all participants. Patients in the intervention group will be asked to send daily videos of the ACT, initially for 7 days and then weekly for a total of 12 weeks. These videos will be assessed by two observers and the technique will be rated correct/ incorrect as per the checklist. The other group will do physiotherapy as usual. At the end of 12 weeks, following parameters will be assessed in both the groups. 1. ACT technique will be assessed physically by 2 independent assessors. If there is any discrepancy a 3rd person will assess who will also be masked. 2. Diary record check 3. Inhaler count (ICS) 4. Spirometry parameters -FeV1 FVC, FEV1/ FVC, PEF, FEF (25-75) 5. Ease of sputum expectoration 6. Number of exacerbations requiring antibiotic usage and/or hospitalization 7. Shwachman-Kulczycki clinical score 8. Revised CF- QOL score Duration of treatment : The patients will receive standard treatment for their condition. The videos will be observed for 12 weeks.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the adherence with correct technique for airway clearance therapy in children with cystic fibrosis of 1 month to 18 years of age using video based direct observation physiotherapy (VDOP) approach.	To evaluate the adherence with correct technique for airway clearance therapy in children with cystic fibrosis of 1 month to 18 years of age using video based direct observation physiotherapy (VDOP) approach. \| Outcome- Ratio (%) between the number of sessions performed daily to the prescribed daily sessions of ACT as reported by self-reported adherence (diary records) in both the groups.
Outcome- Ratio (%) between the number of sessions performed daily to the prescribed daily sessions of ACT as reported by self-reported adherence (diary records) in both the groups.	To evaluate the adherence with correct technique for airway clearance therapy in children with cystic fibrosis of 1 month to 18 years of age using video based direct observation physiotherapy (VDOP) approach. \| Outcome- Ratio (%) between the number of sessions performed daily to the prescribed daily sessions of ACT as reported by self-reported adherence (diary records) in both the groups.

Secondary Outcome Measures

Name	Time	Method
evaluate	1.Improvement in lung function by spirometry parameters

Trial Locations

Locations (1): AIIMS, New Delhi
🇮🇳
Delhi, DELHI, India
AIIMS, New Delhi
🇮🇳Delhi, DELHI, India
Dr Sheetal Agarwal
Principal investigator
9310034300
drsheetalshah@gmail.com