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Healthbot Support for Medication Adherence

N/A

Recruiting

Led By Nadia Minian, PhD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to develop and evaluate a healthbot to help people stick to their varenicline regimen, by researching the challenges to adherence and how a healthbot might help.

Who is the study for?

This trial is for treatment-seeking smokers over 18 in Ontario who smoke 10+ cigarettes daily, are ready to start and stick with varenicline for 12 weeks, set a quit date soon, speak English, have a smartphone with data, and commit to follow-ups. It's not for those with varenicline contraindications or pregnant/breastfeeding women.

What is being tested?

The study tests a healthbot designed to help people stick to their varenicline regimen. Participants will use the healthbot over 12 weeks while researchers measure its effectiveness on medication adherence and smoking cessation using interviews and feedback.

What are the potential side effects?

While this study focuses on the healthbot's usability rather than medication side effects, participants should be aware that varenicline can cause nausea, sleep problems (insomnia), constipation, gas and/or vomiting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability

Adoption

Appropriateness

+2 more

Secondary study objectives

Medication Adherence

Smoking Status

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280

50%

Dysgeusia

50%

Anxiety

36%

Sleep Disturbances

29%

Nausea

21%

Agitation

21%

Depression

21%

Headache

14%

Heartburn

14%

Allergies

14%

Cold

14%

Back Pain

Confusion

Aggression

Panic

Stomach Pain

Dizziness

Fatigue

Leg Spasms

Sinusitis

Angina

Increased Blood Pressure

Palpitations

Cellulitis

Rash

Malaise

Weight Gain

Gum Disease

Pharyngitis

Leg Cramps

Muscle Pain

100%

80%

60%

40%

20%

Study treatment Arm

Low Dose Varenicline

Standard Dose Varenicline

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Varenicline healthbotExperimental Treatment1 Intervention

While the exact healthbot features will be based on results from the rapid review, interviews and Wizard of OZ testing, the investigators know from the existing literature on medication adherence, and behaviour change interventions, that the healthbot will provide: 1) reminders for varenicline dosing and schedule; 2) information and suggestions on managing known side effects (the most frequently cited reason for varenicline non-adherence is experiencing side effects); 3) answers to questions about medication use (e.g., what to do if a dose is missed); and 4) support to increase participants' motivation to continue their quit attempts. During the next 12 weeks, participants will be reminded by the healthbot to take their varenicline at the appropriate times, and will be able to interact with the healthbot when they want.

Do I qualify?Apply below to find out