NCT01936311

Brief Summary

The purpose of this study is to test whether having patients identify a self-management goal (health goal), prior to a visit with their primary care provider, leads to health behavior improvement over six weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

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

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2013

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

September 22, 2014

Status Verified

September 1, 2014

Enrollment Period

4 months

First QC Date

September 3, 2013

Last Update Submit

September 18, 2014

Conditions

Keywords

Health BehaviorBehavior changeself-management goalhealth goal

Outcome Measures

Primary Outcomes (1)

  • Self-rated health

    Single item measure of self rated health: "How would you rate your overall health during the past week? (1=Very Poor, 7=Excellent)?" We will compare scores between groups as well as change over 6-weeks between groups.

    6 weeks

Secondary Outcomes (1)

  • Health behavior improvement

    6 Weeks

Study Arms (2)

Control Group

NO INTERVENTION

This group will receive usual care.

Self-Management Goal Elicitation

EXPERIMENTAL

This group will receive usual care alongside a form that helps elicit self-management goals as well as preferred treatment modalities.

Behavioral: Self-management goal elicitation

Interventions

The intervention will be a form, given prior to a primary care visit, that allows patients to express a self-management goal (health goal) they would like to work on, and a preferred treatment modality.

Self-Management Goal Elicitation

Eligibility Criteria

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

You may qualify if:

  • Adult patients (\>18 years of age)
  • Attending primary care visit at Lowry Family Health Center or Level One Physicians
  • English- or Spanish-Speaking

You may not qualify if:

  • Exhibit signs of cognitive impairment or significant hearing impairment
  • Provider recommendation against enrolling in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Level One Physicians

Denver, Colorado, 80204, United States

Location

Lowry Family Health Center

Denver, Colorado, 80230, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

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

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 6, 2013

Study Start

June 1, 2013

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

September 22, 2014

Record last verified: 2014-09

Locations