NCT03495622

Brief Summary

The study is a multi-center 1-year community-based cluster randomized controlled trial to assess the role of a combined community health worker and mobile health intervention in controlling one of the most common cardiovascular risk factors, tobacco use. Participants will include 560 adults, 18-70 years of age, from the urban communities of Dalkhola, West Bengal, and Jabalpur, Madhya Pradesh, India. The hypothesis of the study is that this combined approach can result in increased quit rate among tobacco users.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

March 26, 2018

Last Update Submit

August 6, 2019

Conditions

Smoking Cessation

Keywords

Text messagingCommunity health workerSmoking cessationIndiaCardiovascular mortality

Outcome Measures

Primary Outcomes (1)

  • Quit rate at the end of 1 year

    Self-reported abstinence, biochemically verified, for the past 14 days at the end of 1 year from the start of the intervention.

    1 year

Secondary Outcomes (1)

  • Relapse rate at the end of 1 year

    1 year

Study Arms (2)

Motivational Interviewing/Text messaging

EXPERIMENTAL

Home visits by community health worker to deliver motivational interviewing and set up a structured text messaging strategy designed around a pre-determined quit date for smoking cessation.

Behavioral: Motivational Interviewing/Text messaging

Control

NO INTERVENTION

All participants will receive brief verbal advice about the hazards of smoking and the benefits of smoking cessation.

Interventions

Motivational Interviewing/Text messagingBEHAVIORAL

The intervention is a multi-component one that is tailored to the individual and will target smoking cessation. The CHW, after identifying the individual's stage of behavior change, will provide motivational interviewing and set up an automatic text messaging system with their mobile phones that are structured around a quit date chosen by the participant. The CHW visits are pre-determined and she monitors the progress of the individual regularly. She may restart the process of determining the stage of behavior change for those who relapse or quit the intervention midway thereby reassigning them to the appropriate phase of the trial

Motivational Interviewing/Text messaging

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults between the ages of 18 and 70 years, who smoke cigarettes or bidis daily
  • Individuals able and willing to give informed consent

You may not qualify if:

  • Individuals who are bed-bound because of acute illness or have a chronic condition that makes them bed-bound.
  • Individuals who refuse consent
  • Individuals who do not reside in the community and are only visiting, therefore being unlikely to be available for continuous follow up. Individuals who have stayed less than 6 months in the study area, or whose name is not on the voter list of the area will be excluded.
  • Individuals who are not able to participate in the intervention due to significant disabilities, such as blindness, deafness or the intellectually disabled. This determination is at the discretion of the community health worker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SEHAT

Jabalpur, Madhya Pradesh, India

Location

SEHAT

Dalkhola, West Bengal, 733201, India

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Cluster Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine Case Western Reserve University School of Medicine/ Director Cardiovascular and Pulmonary Rehabilitation program University Hospitals Cleveland Medical Center, Division of Cardiovascular Medicine

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 12, 2018

Study Start

January 1, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 8, 2019

Record last verified: 2019-08

Locations

IN(2)