NCT01013857

Brief Summary

Patients with poorly controlled hypertension will have improved hypertensive control with telephone coaching and with telephone coaching combined with home-titration of medications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

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

January 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

November 12, 2009

Last Update Submit

March 7, 2022

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure

    6 months

Secondary Outcomes (1)

  • Diastolic blood pressure

    6 months

Study Arms (2)

Health coaching

ACTIVE COMPARATOR

Phone patients every week to discuss medication adherence

Behavioral: Health coaching

Health coaching plus home-titration

EXPERIMENTAL

Health coaches call patients every week to discuss medication adherence and to intensify medications if appropriate according to physician-created algorithm

Behavioral: Health coaching plus home titration

Interventions

Health coachingBEHAVIORAL

Calling patients every week to discuss medication adherence

Health coaching
Health coaching plus home titrationBEHAVIORAL

Calling patients every week and intensifying medications if appropriate based on physician-created algorithm

Health coaching plus home-titration

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • blood pressure readings above 145/90.

You may not qualify if:

  • Cognitive impairment,
  • Short life expectancy,
  • Creatinine greater than 1.5,
  • Inability to check blood pressures at home.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (1)

  • Bennett H, Laird K, Margolius D, Ngo V, Thom DH, Bodenheimer T. The effectiveness of health coaching, home blood pressure monitoring, and home-titration in controlling hypertension among low-income patients: protocol for a randomized controlled trial. BMC Public Health. 2009 Dec 10;9:456. doi: 10.1186/1471-2458-9-456.

    PMID: 20003300DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Thomas Bodenheimer, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2009

First Posted

November 16, 2009

Study Start

January 1, 2009

Primary Completion

February 1, 2010

Study Completion

December 1, 2011

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations

US(1)