NCT02653573

Brief Summary

This study was designed to evaluate the feasibility of a telephone-based health coach self-management intervention for young adults.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

December 28, 2015

Last Update Submit

October 26, 2016

Conditions

Health BehaviorHypertension

Keywords

young adult

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction

    Patient satisfaction survey of feasibility study

    3 months

Secondary Outcomes (1)

  • Out-of-clinic blood pressures

    3 months

Study Arms (1)

Intervention

EXPERIMENTAL

Telephone health coaching over 3 months with supporting education materials.

Behavioral: Coaching

Interventions

CoachingBEHAVIORAL

Self-management education

Intervention

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old at the start of the study
  • previous hypertension ICD-9 coded office visits
  • uncontrolled hypertension (≥140/90 mmHg) based on the last ambulatory blood pressure reading

You may not qualify if:

  • Chronic Kidney Disease (Stage 4 or 5 or Dialysis)
  • Congestive Heart Failure, Any Etiology
  • Activated Healthcare Power of Attorney
  • Skilled nursing facility or correctional facility residence
  • Currently enrolled in case management or chronic disease management support services
  • Sensitive condition diagnosis (e.g. HIV)
  • Prescribed warfarin, novel oral anticoagulant, or insulin
  • Diagnosis of sickle cell anemia or cystic fibrosis
  • Prior stroke, myocardial infarction, coronary artery revascularization
  • Syncope within past 12 months
  • Prior or planned organ transplant
  • Chemotherapy or radiation therapy within 6 months
  • Severely impaired hearing or speech
  • Current participation in another research study
  • Pregnant/planning to become pregnant in the next 12 months
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health BehaviorHypertension

Condition Hierarchy (Ancestors)

BehaviorVascular DiseasesCardiovascular Diseases

Study Officials

  • Heather M Johnson, MD, MS

    University of WI School of Medicine and Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2015

First Posted

January 12, 2016

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10