Patient Health BehaviorsNCT01936311
Study of Screening Self-management Goals on Short Term Behavior Change
A study testing Self-management goal elicitation in people with Patient Health Behaviors, run by Denver Health and Hospital Authority at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Health Behaviors
- What is being tested?
- Self-management goal elicitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years of age)
- Attending primary care visit at Lowry Family Health Center or Level One Physicians
- English- or Spanish-Speaking
Who cannot join
- Exhibit signs of cognitive impairment or significant hearing impairment
- Provider recommendation against enrolling in study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Level One Physicians
Denver, Colorado, 80204
Lowry Family Health Center
Denver, Colorado, 80230
About this study
Official title: 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.
- Conditions
- Patient Health Behaviors
- Being tested
- Self-management goal elicitation
- Keywords
- Health Behavior, Behavior change, self-management goal, health goal
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management goal elicitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self-management goal elicitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
Health behavior improvement
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.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Health BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Advancing Care Together, Colorado Health Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936311
- Sponsor's protocol ID
- CHF-3848
- Other IDs
- 13-1523
- Status last verified
- Sep 2014
- First submitted
- 3 Sep 2013
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01936311
- Acronym / sponsor ID
- CHF-3848
- Conditions
- Patient Health Behaviors
- Keywords
- Health Behavior, Behavior change, self-management goal, health goal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- Advancing Care Together, Colorado Health Foundation
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This group will receive usual care. |
| Self-Management Goal Elicitation | Experimental | Behavioral: Self-management goal elicitationThis group will receive usual care alongside a form that helps elicit self-management goals as well as preferred treatment modalities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (>18 years of age)
- Attending primary care visit at Lowry Family Health Center or Level One Physicians
- English- or Spanish-Speaking
Key exclusion criteria (2 listed)
- Exhibit signs of cognitive impairment or significant hearing impairment
- Provider recommendation against enrolling in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management goal elicitationThe 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. | Behavioural | Self-Management Goal Elicitation |
Primary outcome
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.
1 secondary outcome
Health behavior improvement
Time frame: 6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management goal elicitation in people with Patient Health Behaviors, run by Denver Health and Hospital Authority at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-rated health (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2014.