DiabetesPhase 2NCT01156974
Care Guides in the Primary Care Office (Phase II)
A Phase 2 study testing education and care guide and education only in people with Diabetes and Hypertension, run by Allina Health System at 1 site in United States.
Trial summary
Trained lay persons ("care guides") working with chronic disease patients and their providers can help outpatients with diabetes, hypertension, and congestive heart failure achieve standard clinical care goals Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diabetes, Hypertension, Congestive Heart Failure
- What is being tested?
- education and care guide and education only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,135 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Apr 2012
- Phase
- Phase 2
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages 18-79
- diagnoses of diabetes, hypertension, and/or congestive heart failure
Who cannot join
- pregnant
- unable to understand randomization process
Trial locations and contacts
1 site in 1 country.
United States1 site
Allina Hospitals and Clinics
Minneapolis, Minnesota, 55407
About this study
Official title: Care Guides: Can Trained Laypersons Help Manage Chronic Disease? A Randomized Trial.
Trained lay persons ("care guides") working with chronic disease patients and their providers can help outpatients with diabetes, hypertension, and congestive heart failure achieve standard clinical care goals
Read the detailed description
In a randomized parallel group multi-site trial looking at achievement of standard recommended treatment goals at baseline and one year later by 2135 patients with diabetes, hypertension, and congestive heart failure, we tested the hypothesis that adding a lay person with brief training to usual care would improve clinical outcomes. These "care guides" were culturally matched to patients served, similar to community health workers, but were located in 6 diverse primary care health clinics where they could meet patients face-to-face. They were asked to assist communication in both directions between providers and patients, taking advantage of their status as non-authority figures. They were given two weeks' training about these diseases and behavior change theory. This intervention was designed to be low cost, easy to implement, and to integrate into rather than change clinic work flow.
- Conditions
- Diabetes, Hypertension, Congestive Heart Failure
- Being tested
- education and care guide, education only
- Keywords
- care management, chronic disease, outpatient
- Medical subject headings
- Diabetes Mellitus, Hypertension, Heart Failure, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education and care guideBehavioural
Also called Active care management
Patients receive education about care goals, and in-person and telephone counseling of unspecified frequency over one year to achieve goals
education onlyBehavioural
patients receive education about care goals
| Study group | Role | What they receive |
|---|---|---|
| care guide | Experimental | patients receive education about care goals and work with a care guide to achieve goals Receives: Behavioral: education and care guide |
| no care guide | Active comparator | patients receive education about care goals and usual care to achieve goals Receives: Behavioral: education only |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in number of care goals met
Predetermined care goals as recommended by national authorities such as American Diabetes Association, American Heart Association, JNC-7.
Measured: one year
Secondary outcomes (1)
Kinds of patients who benefit from working with a care guide
demographic, clinical, and attitudinal characteristics of patients who benefit
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard F Adair, MD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156974
- Sponsor's protocol ID
- 3096-1E
- Status last verified
- Apr 2019
- First submitted
- 2 Jul 2010
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Adair R, Christianson J, Wholey DR, White K, Town R, Lee S, Britt H, Lund P, Lukasewycz A, Elumba D. Care guides: employing nonclinical laypersons to help primary care teams manage chronic disease. J Ambul Care Manage. 2012 Jan-Mar;35(1):27-37. doi: 10.1097/JAC.0b013e31823b0fbe.
PubMed 22156953Adair R, Wholey DR, Christianson J, White KM, Britt H, Lee S. Improving chronic disease care by adding laypersons to the primary care team: a parallel randomized trial. Ann Intern Med. 2013 Aug 6;159(3):176-84. doi: 10.7326/0003-4819-159-3-201308060-00007.
PubMed 23922063Wholey DR, White KM, Adair R, Christianson JB, Lee S, Elumba D. Care guides: an examination of occupational conflict and role relationships in primary care. Health Care Manage Rev. 2013 Oct-Dec;38(4):272-83. doi: 10.1097/HMR.0b013e31825f3df9.
PubMed 22728580
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Guides: Can Trained Laypersons Help Manage Chronic Disease? A Randomized Trial.
- ClinicalTrials.gov ID
- NCT01156974
- Acronym / sponsor ID
- 3096-1E
- Conditions
- Diabetes, Hypertension, Congestive Heart Failure
- Keywords
- care management, chronic disease, outpatient
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,135 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 5 Jul 2010 (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.
Trained lay persons ("care guides") working with chronic disease patients and their providers can help outpatients with diabetes, hypertension, and congestive heart failure achieve standard clinical care goals
Detailed description
In a randomized parallel group multi-site trial looking at achievement of standard recommended treatment goals at baseline and one year later by 2135 patients with diabetes, hypertension, and congestive heart failure, we tested the hypothesis that adding a lay person with brief training to usual care would improve clinical outcomes. These "care guides" were culturally matched to patients served, similar to community health workers, but were located in 6 diverse primary care health clinics where they could meet patients face-to-face. They were asked to assist communication in both directions between providers and patients, taking advantage of their status as non-authority figures. They were given two weeks' training about these diseases and behavior change theory. This intervention was designed to be low cost, easy to implement, and to integrate into rather than change clinic work flow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| care guide | Experimental | Behavioral: education and care guidepatients receive education about care goals and work with a care guide to achieve goals |
| no care guide | Active comparator | Behavioral: education onlypatients receive education about care goals and usual care to achieve goals |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ages 18-79
- diagnoses of diabetes, hypertension, and/or congestive heart failure
Key exclusion criteria (2 listed)
- pregnant
- unable to understand randomization process
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 |
|---|---|---|
| education and care guideAlso: Active care managementPatients receive education about care goals, and in-person and telephone counseling of unspecified frequency over one year to achieve goals | Behavioural | care guide |
| education onlypatients receive education about care goals | Behavioural | no care guide |
Primary outcome
change in number of care goals met
Time frame: one year
Predetermined care goals as recommended by national authorities such as American Diabetes Association, American Heart Association, JNC-7.
1 secondary outcome
Kinds of patients who benefit from working with a care guide
Time frame: one year
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 8 Apr 2019.
- Results publication: PubMed 22156953Adair R, Christianson J, Wholey DR, White K, Town R, Lee S, Britt H, Lund P, Lukasewycz A, Elumba D. Care guides: employing nonclinical laypersons to help primary care teams manage chronic disease. J Ambul Care Manage. 2012 Jan-Mar;35(1):27-37. doi: 10.1097/JAC.0b013e31823b0fbe.
- Results publication: PubMed 23922063Adair R, Wholey DR, Christianson J, White KM, Britt H, Lee S. Improving chronic disease care by adding laypersons to the primary care team: a parallel randomized trial. Ann Intern Med. 2013 Aug 6;159(3):176-84. doi: 10.7326/0003-4819-159-3-201308060-00007.
- Results publication: PubMed 22728580Wholey DR, White KM, Adair R, Christianson JB, Lee S, Elumba D. Care guides: an examination of occupational conflict and role relationships in primary care. Health Care Manage Rev. 2013 Oct-Dec;38(4):272-83. doi: 10.1097/HMR.0b013e31825f3df9.
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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.
Richard F Adair, MD principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing education and care guide and education only in people with Diabetes and Hypertension, run by Allina Health System at 1 site 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 2 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 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change in number of care goals met (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01156974, which also lists 3 linked publications.
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 8 Apr 2019.