Type 2 DiabetesNCT00965510
SeaCare's Care Coordination for Diabetes Management in a Primary Care Office
A study testing care coordination in people with Type 2 Diabetes, run by SeaCare Health Services at 1 site in United States.
Trial summary
The purpose of this study is to determine whether it is possible to improve health outcomes for patients with Type II diabetes, a community-based health care agency will offer care coordination to half of a study group in a family practice office. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- care coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2011
- 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
- Diabetes type II
Who cannot join
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improved Management of Type II Diabetes in a Primary Care Office With Targeted Case Management
The purpose of this study is to determine whether it is possible to improve health outcomes for patients with Type II diabetes, a community-based health care agency will offer care coordination to half of a study group in a family practice office. The intervention will include assessing patients' status using two instruments:
a depression screen (the PHQ9) and a motivation to change scale (the Patient Activation Measure, PAM). A masters-level social worker will counsel patients in the intervention group. Changes in patients' health status, PHQ9 scores and PAM scores over one year will be measured. Outcomes will be compared between the study group and the group without intervention.
- Conditions
- Type 2 Diabetes
- Being tested
- care coordination
- Keywords
- diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care coordinationBehavioural
patients receive care coordination to improve their type II diabetes
| Study group | Role | What they receive |
|---|---|---|
| Care Coordination | Experimental | Patients receive care coordination to improve their diabetes. Receives: Behavioral: care coordination |
| control | No intervention | patients with type II diabetes receive usual health care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on PHQ9, PAM and health indicators
Measured: 1 year
Secondary outcomes (1)
Satisfaction with care coordination model.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: insufficient recruitment of control and study patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- SeaCare Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- New Hampshire Charitable Foundation
- Investigators
- Gwendolyn Gladstone, MD, Principal investigator, SeaCare Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965510
- Sponsor's protocol ID
- 9118277Downing306
- Status last verified
- Sep 2010
- First submitted
- 24 Aug 2009
- Last updated
- 30 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Management of Type II Diabetes in a Primary Care Office With Targeted Case Management
- ClinicalTrials.gov ID
- NCT00965510
- Acronym / sponsor ID
- 9118277Downing306
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment of control and study patients
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SeaCare Health ServicesUniversity, hospital or other
- Collaborators
- New Hampshire Charitable Foundation
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Aug 2009 (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 determine whether it is possible to improve health outcomes for patients with Type II diabetes, a community-based health care agency will offer care coordination to half of a study group in a family practice office. The intervention will include assessing patients' status using two instruments:
a depression screen (the PHQ9) and a motivation to change scale (the Patient Activation Measure, PAM). A masters-level social worker will counsel patients in the intervention group. Changes in patients' health status, PHQ9 scores and PAM scores over one year will be measured. Outcomes will be compared between the study group and the group without intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care Coordination | Experimental | Behavioral: care coordinationPatients receive care coordination to improve their diabetes. |
| control | No intervention | –patients with type II diabetes receive usual health care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetes type II
Key exclusion criteria (1 listed)
- Non-English speaking
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 |
|---|---|---|
| care coordinationpatients receive care coordination to improve their type II diabetes | Behavioural | Care Coordination |
Primary outcome
Scores on PHQ9, PAM and health indicators
Time frame: 1 year
1 secondary outcome
Satisfaction with care coordination model.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: insufficient recruitment of control and study patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2011.
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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.
Gwendolyn Gladstone, MD principal investigator
SeaCare Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing care coordination in people with Type 2 Diabetes, run by SeaCare Health Services 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 30 Sep 2011. 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.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment of control and study patients). Results are not available in the source record.
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?
Scores on PHQ9, PAM and health indicators (time frame: 1 year). 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 30 Sep 2011; AzTrials last refreshed its copy on 7 Nov 2026.