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To determine the role of shared decision making in tobacco cessation when provided at the primary health centers to tobacco users

Efficacy of shared decision making for tobacco cessation at primary care level â?? A Randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046793
Enrollment
596
Registered
2022-10-26
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z720- Tobacco use

Interventions

Intervention1: Shared decision making: Participants and health professionals will make a shared decision for the pharmacotherapy provided in the health care centers for tobacco cessation Intervention2

Sponsors

Science and Engineering Research Board
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients attending the outpatient clinics of PHCs will be the study population, Patients of age 18 years and above, Patients with history of tobacco use during the last one or more years and willing to quit, Patients being able to read and understand English or Hindi, Patient should be a resident of the area under the jurisdiction of the health facility, Patients willing to give consent

Exclusion criteria

Exclusion criteria: Patients below 18years of age, Patients who do not have the mental capacity to provide informed consent and complete the study, Migrant patients will not be included

Design outcomes

Primary

MeasureTime frame
Urinary cotinine analysis for evaluating 7 day Point prevalence abstinence of study participants (no tobacco used during the preceding 7days) after three months of intervention and six months of follow up to determine the tobacco use status. For confirmation of not using tobacco in any form in the past 7 days will be tested using immune-chromatographic test strip .Timepoint: 3 and 6 months

Secondary

MeasureTime frame
1. Cumulative days of tobacco abstinence within 6 months of follow-up 2. Self-reported number of quit attempts within 6 months 3. Self-reported temporary or complete relapse to tobacco use within 6 months 4. Rate of withdrawal from the intervention among the study participants within 6months 5. Change in knowledge of tobacco users before and after intervention 6. Patient satisfaction with the intervention Timepoint: 3 and 6 months

Countries

India

Contacts

Public ContactDr Sonu Goel

PGIMER Chandigarh

sonugoel007@yahoo.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026