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Health Coaching for Patients with Comorbidities (Tipping Points Trial)

N/A
Recruiting
Led By Jonathan N Tobin, PhD
Research Sponsored by Clinical Directors Network
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 24 months
Awards & highlights

Tipping Points Trial Summary

This trial will compare the outcomes of patients randomized in clusters by site within four FQHC networks in New York City (NYC) and Chicago to either: 1) the Patient Centered Medical Home (PCMH); or 2) the Patient Centered Home plus a health coaching intervention that employs a positive affect/self-affirmation intervention to help motivate patients to succeed at implementing self-management by setting life goals (experimental).

Who is the study for?
This trial is for adult patients with multiple chronic diseases (comorbidity index ≥4) who are already receiving care at certain health centers in NYC and Chicago. It's not open to those with metastatic cancer, end-stage renal disease on dialysis, severe mental illness, language barriers (non-English/Spanish speakers), post-transplant status, or drug/alcohol abuse issues.Check my eligibility
What is being tested?
The study tests if adding a health coaching intervention to the standard Patient Centered Medical Home care can prevent serious health declines leading to hospital stays and disability in high-risk patients. Participants will be grouped by their healthcare center location and randomly assigned one of the two approaches.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like health coaching rather than drugs or medical procedures, traditional side effects are not expected. However, participants may experience varying levels of stress or anxiety related to lifestyle changes encouraged by the program.

Tipping Points Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Unplanned Hospitalizations
World Health Organization Disability Assessment Scale (WHODAS) Scale
Secondary outcome measures
Health Education Impact Questionnaire
Number of Emergency Department Visits
Patient Activation Measure

Tipping Points Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Patient Centered Medical Home (PCMH) plus Health CoachExperimental Treatment1 Intervention
A health coaching intervention that employs a positive affect/self-affirmation intervention to help motivate patients to succeed at implementing self-management by setting life goals, in addition to the usual care provided for patients with multiple chronic diseases by the The Patient-Centered Medical Home (PCMH).
Group II: Patient Centered Medical Home (PCMH)Active Control1 Intervention
Usual care provided for patients with multiple chronic diseases by the Patient-Centered Medical Home (PCMH).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Health Coach Intervention
2015
N/A
~30

Find a Location

Who is running the clinical trial?

Clinical Directors NetworkLead Sponsor
12 Previous Clinical Trials
12,326 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,995,538 Total Patients Enrolled
1 Trials studying Comorbidities
750 Patients Enrolled for Comorbidities
Jonathan N Tobin, PhDPrincipal InvestigatorClinical Directors Network
2 Previous Clinical Trials
1,080 Total Patients Enrolled

Media Library

Health Coach Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04176510 — N/A
Comorbidities Research Study Groups: Patient Centered Medical Home (PCMH) plus Health Coach, Patient Centered Medical Home (PCMH)
Comorbidities Clinical Trial 2023: Health Coach Intervention Highlights & Side Effects. Trial Name: NCT04176510 — N/A
Health Coach Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04176510 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size in this research study?

"Affirmative, the data found on clinicaltrials.gov confirms that this research is presently welcoming volunteers. This project was first made available to potential participants on November 20th 2019 and its details were last revised October 3rd 2021. In total, 1920 individuals need to be recruited from 4 different medical centres."

Answered by AI

Are recruitment efforts ongoing for this clinical experiment?

"Clinicaltrials.gov has revealed that this clinical trial is recruiting, with the advertisement first appearing on November 20th 2019 and being recently amended on October 3rd 2021."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
How old are they?
65+
What site did they apply to?
Friend Health, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Preventing Tipping Points in High Comorbidity Patients: A Lifeline From Health Coaches
2019. "Preventing Tipping Points in High Comorbidity Patients: A Lifeline From Health Coaches". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04176510.
~507 spots leftby Dec 2025
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