TB - TuberculosisCoronavirus19NCT04412239
To Assess the Efficiency and Satisfaction of Pharmacist Giving Patient-centred Advice on Telephone Consultation in TB Patients: Experience of the COVID-19 Pandemic
A study testing Patient-centred advice on Telephone Consultation in TB Patients: in people with TB - Tuberculosis and Patient Satisfaction, run by Xi'an Jiaotong University at 2 sites in Pakistan.
Trial summary
The COVID-19 pandemic might be an opportunity to review and refine our practices in anti TB treatment. For the follow-up of selected patients, telephone consultations may be efficient and cost-effective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TB - Tuberculosis, Patient Satisfaction
- What is being tested?
- Patient-centred advice on Telephone Consultation in TB Patients:
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesPakistan
- Study dates
- 20 Apr 2020to 20 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New, smear-positive drug-susceptible TB who have been on treatment for less than two weeks Access to a mobile phone (self-reported)
Who cannot join
- Patients who do not have regular access to a mobile phone Patients who have previously received TB treatment Patients who have another member in their household who is already a part of the study
Trial locations and contacts
2 sites in 1 country.
Yu Fang, Phd contact
Pakistan2 sites, 2 recruiting
- Recruiting
Dhq Bannu Kpk
Bannu, KPK, 2800
Farman Ull ah Khan, +92331-3319443131, farmankhan@bs.qau.pk
- Recruiting
District Bannu TB Control Center
Bannu, KPK, 2800
Asif Ul Khan, Master, 0092334087008, asifkhanustb@gmail.com
Farman Ul Khan, Master
About this study
The COVID-19 pandemic might be an opportunity to review and refine our practices in anti TB treatment. For the follow-up of selected patients, telephone consultations may be efficient and cost-effective. The aim of the study is to assess the efficiency and the satisfaction with telephone consultation for the pharmacist and the TB patient. The study was conducted in tertiary care hospital TB control centres patients.
Read the detailed description
Tuberculosis (TB) is the world's biggest killer among infectious diseases, claiming more than 4000 lives each day. The unprecedented coronavirus pandemic seriously impacts people with pre-existing health conditions. People who have TB are usually more vulnerable to other infections, including the novel coronavirus, due to pre-existing lung damage. They are at a higher risk of developing complications from COVID-19. Certain populations are at greater risk of TB, because of where they live, where they work or because of other socio-economic factors which result in them experiencing barriers to accessing health services.
- Conditions
- TB - Tuberculosis, Patient Satisfaction
- Being tested
- Patient-centred advice on Telephone Consultation in TB Patients:
- Medical subject headings
- Latent Tuberculosis, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-centred advice on Telephone Consultation in TB Patients:Behavioural
The primary aim was to assess the efficiency and the satisfaction of the telephone consultation. The COVID-19 pandemic might be an opportunity to review and refine our practices in TB care. For the follow-up of selected patients, telephone consultations may be efficient and cost effective.
| Study group | Role | What they receive |
|---|---|---|
| Telephone Consultation in TB Patients | Experimental | The COVID-19 pandemic might be an opportunity to review and refine our practices in TB care. For the follow-up of selected patients, telephone consultations may be efficient and cost-effective. Receives: Behavioral: Patient-centred advice on Telephone Consultation in TB Patients: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of the telephone consultation,
To improve patient centered care/patient prescription refill
Measured: 2 Months
Patient satisfaction
Patient satisfaction Patient satisfaction resulting from pharmacist-led pharmaceutical care will be assessed Patient satisfaction feedback (PSF)
Measured: 2 Month
Secondary outcomes (1)
Adherence Rate
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start20 Apr 2020
- Primary completion20 Dec 2020 (estimated)
- Study completion20 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TB - TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- Pakistan Institute of Medical Sciences, District Headquarter Hospital Bannu Pakistan
- Responsible party
- Principal investigator, Farman Ullah Khan, Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412239
- Sponsor's protocol ID
- NO, F6-2017/NTP-ADMIN
- Acronym
- Coronavirus19
- Status last verified
- Nov 2020
- First submitted
- 30 May 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Efficiency and Satisfaction of Pharmacist Giving Patient-centred Advice on Telephone Consultation in TB Patients: Experience of the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04412239
- Acronym / sponsor ID
- Coronavirus19 / NO, F6-2017/NTP-ADMIN
- Conditions
- TB - Tuberculosis, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Pakistan Institute of Medical Sciences, District Headquarter Hospital Bannu Pakistan
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The COVID-19 pandemic might be an opportunity to review and refine our practices in anti TB treatment. For the follow-up of selected patients, telephone consultations may be efficient and cost-effective. The aim of the study is to assess the efficiency and the satisfaction with telephone consultation for the pharmacist and the TB patient. The study was conducted in tertiary care hospital TB control centres patients.
Detailed description
Tuberculosis (TB) is the world's biggest killer among infectious diseases, claiming more than 4000 lives each day. The unprecedented coronavirus pandemic seriously impacts people with pre-existing health conditions. People who have TB are usually more vulnerable to other infections, including the novel coronavirus, due to pre-existing lung damage. They are at a higher risk of developing complications from COVID-19. Certain populations are at greater risk of TB, because of where they live, where they work or because of other socio-economic factors which result in them experiencing barriers to accessing health services.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telephone Consultation in TB Patients | Experimental | Behavioral: Patient-centred advice on Telephone Consultation in TB Patients:The COVID-19 pandemic might be an opportunity to review and refine our practices in TB care. For the follow-up of selected patients, telephone consultations may be efficient and cost-effective. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- New, smear-positive drug-susceptible TB who have been on treatment for less than two weeks Access to a mobile phone (self-reported)
Key exclusion criteria (1 listed)
- Patients who do not have regular access to a mobile phone Patients who have previously received TB treatment Patients who have another member in their household who is already a part of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-centred advice on Telephone Consultation in TB Patients:The primary aim was to assess the efficiency and the satisfaction of the telephone consultation. The COVID-19 pandemic might be an opportunity to review and refine our practices in TB care. For the follow-up of selected patients, telephone consultations may be efficient and cost effective. | Behavioural | Telephone Consultation in TB Patients |
Primary outcome
Efficiency of the telephone consultation,
Time frame: 2 Months
To improve patient centered care/patient prescription refill
Patient satisfaction
Time frame: 2 Month
Patient satisfaction Patient satisfaction resulting from pharmacist-led pharmaceutical care will be assessed Patient satisfaction feedback (PSF)
1 secondary outcome
Adherence Rate
Time frame: 2 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Fang, Phd contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-centred advice on Telephone Consultation in TB Patients: in people with TB - Tuberculosis and Patient Satisfaction, run by Xi'an Jiaotong University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farman Ul Khan, Master (003319443131, farmankhan@bs.qau.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of the telephone consultation, (time frame: 2 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.