- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01936311
Study of Screening Self-management Goals on Short Term Behavior Change
September 18, 2014 updated by: Denver Health and Hospital Authority
Study of Screening for Patients Self-selected Health Goal and Treatment Modality Prior to Primary Care Visit and the Effect on Short-term Behavior Change
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
167
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80204
- Level One Physicians
-
Denver, Colorado, United States, 80230
- Lowry Family Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients (>18 years of age)
- Attending primary care visit at Lowry Family Health Center or Level One Physicians
- English- or Spanish-Speaking
Exclusion Criteria:
- Exhibit signs of cognitive impairment or significant hearing impairment
- Provider recommendation against enrolling in study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
This group will receive usual care.
|
|
Experimental: Self-Management Goal Elicitation
This group will receive usual care alongside a form that helps elicit self-management goals as well as preferred treatment modalities.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-rated health
Time Frame: 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health behavior improvement
Time Frame: 6 Weeks
|
Our secondary outcome measure will include a measure of behavior specific improvements.
We will evaluate both component improvements for their specified behavior, as well as the composite score of negative health behaviors assessed from a series of questions.
|
6 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
September 3, 2013
First Submitted That Met QC Criteria
September 5, 2013
First Posted (Estimate)
September 6, 2013
Study Record Updates
Last Update Posted (Estimate)
September 22, 2014
Last Update Submitted That Met QC Criteria
September 18, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- CHF-3848
- 13-1523 (Other Identifier: COMIRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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