Type I or Type II Diabetes (Excludes Gestational Diabetes)Phase 3NCT00254501

Empowering Patients to Better Manage Diabetes Through Self-Care

A Phase 3 study testing Pharmacist Counseling and Educational materials in people with Type I or Type II Diabetes (Excludes Gestational Diabetes), run by Oregon State University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Type I or Type II Diabetes (Excludes Gestational Diabetes)
What is being tested?: Pharmacist Counseling and Educational materials
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: No sites listed yet
Study dates: Nov 2005to Jun 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 I or Type II)
enrolled in health plan with participating employer
age 18 or older
willing and able to provide informed consent

Who cannot join

gestational diabetes

About this study

This study will look at the impact of health insurance benefits on self management of diabetes for people with this condition. Studies have shown that when people with diabetes manage their disease better, they stay healthier. Our goal in this study is to help those with diabetes better manage their disease (self-care). We will compare two types of health insurance benefits in this study. We want to see if one set of benefits improves self-care more than the other one.

Read the detailed description

The objective of this particular study is to determine if the addition of regular pharmacist visits to usual care can improve clinical outcomes in patients with diabetes. The central hypothesis is that a program overseen by community pharmacists that empowers patients to self-manage their diabetes will lead to improved clinical and humanistic outcomes and will be cost-effective. Strong preliminary data collected from other sites suggests that patient empowerment programs are effective at reducing hemoglobin A1C after 12 months and in reducing the total cost of care. This hypothesis will be tested by pursuing three specific aims to evaluate the impact of a pharmacist-administered diabetes patient empowerment program on:

clinical markers for diabetes and related metabolic disorders;
the cost of care and resource utilization; and
patient knowledge and perceived ability to manage diabetes. There is an additional specific aim to assess the pharmacists with respect to satisfaction with the training program and the overall project, the activities conducted in patient sessions, and the time taken to complete the visits in this study.

Conditions: Type I or Type II Diabetes (Excludes Gestational Diabetes)
Being tested: Pharmacist Counseling, Educational materials
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.

Pharmacist CounselingBehavioural
Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items. Patients also received waiver of out-of-pocket expenses for diabetes care.
Educational materialsBehavioural
Patients received educational materials (handouts) in the mail. This was assumed to be of minimal effectiveness. Patients also received waiver of out-of-pocket expenses for diabetes care.

Study groups in NCT00254501
Study group	Role	What they receive
Usual Care plus out-of-pocket cost waiver	Active comparator	Patients received educational materials (handouts) in the mail. This was assumed to be of minimal effectiveness. Patients also received waiver of out-of-pocket expenses for diabetes care. Receives: Behavioral: Educational materials
EMPOWER	Experimental	Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items. Patients also received waiver of out-of-pocket expenses for diabetes care. Receives: Behavioral: Pharmacist Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Hemoglobin A-1C From Baseline
Compare changes in Hemoglobin A-1C from baseline between the two groups.
Measured: baseline and 12 months

Secondary outcomes (3)

Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides
Changes from baseline in LDL, HDL, total cholesterol, triglycerides.
Sample sizes for each individual test (usual care plus out-of-pocket cost waiver; EMPOWER group):
1. LDL
2. HDL
3. Total cholesterol
4. Triglycerides
Measured: baseline and 12 months
Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months
Changes in claims-based economic data on costs of total health care, diabetes medications, and diabetes supplies from baseline to 12 months. Only participants who had a claim in the 12 months prior to baseline were included in these analyses. The resulting sample sizes (usual care plus out-of-pocket cost waiver; EMPOWER group) for these outcomes are:
1. Total cost of care
2. Costs of diabetes medications
3. Costs of diabetes supplies
Measured: baseline to 12 months
Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months
Psycho-social aspects of diabetes knowledge and empowerment. Sample sizes are in parentheses (usual care plus out-of-pocket cost waiver; EMPOWER group):
1. Changes from baseline to 12 months for the Diabetes Empowerment Scale (DES). Mean score for 28 items each scored as a Likert scale from 1 to 5. Higher scores correspond to greater empowerment
2. Changes from baseline to 12 months for the Adherence Starts with Knowledge (ASK-20) adherence barrier test total barrier score (TBC). The TBC has a range from 0 to 18 and higher scores correspond to greater barriers.
3. Changes from baseline to 12 months for understanding of diabetes. This is a single question: "How would you rate your understanding of diabetes and its treatment?" which uses a 7-point scale Likert scale as the response from 1 (poor) to 7 (excellent).
Measured: From baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2005Jun 2011

First posted16 Nov 2005 (estimated)
Study startNov 2005
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type I or Type II Diabetes (Excludes Gestational Diabetes)Studies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00254501
Sponsor's protocol ID: OSU_COP_PP_0105
Other IDs: IRB Application 2979
Status last verified: Jul 2016
First submitted: 14 Nov 2005
Last updated: 22 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Kraemer DF, Kradjan WA, Bianco TM, Low JA. A randomized study to assess the impact of pharmacist counseling of employer-based health plan beneficiaries with diabetes: the EMPOWER study. J Pharm Pract. 2012 Apr;25(2):169-79. doi: 10.1177/0897190011418513. Epub 2011 Oct 10.
PubMed 21987530

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Empowering Patients to Better Manage Diabetes Through Self-Care
ClinicalTrials.gov ID: NCT00254501
Acronym / sponsor ID: OSU_COP_PP_0105
Conditions: Type I or Type II Diabetes (Excludes Gestational Diabetes)
Keywords: diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Oregon State UniversityUniversity, hospital or other
Collaborators: Sanofi
Study start: Nov 2005
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 16 Nov 2005 (estimated)
Results: Posted 22 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

clinical markers for diabetes and related metabolic disorders;
the cost of care and resource utilization; and
patient knowledge and perceived ability to manage diabetes. There is an additional specific aim to assess the pharmacists with respect to satisfaction with the training program and the overall project, the activities conducted in patient sessions, and the time taken to complete the visits in this study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Usual Care plus out-of-pocket cost waiver	Active comparator	Behavioral: Educational materialsPatients received educational materials (handouts) in the mail. This was assumed to be of minimal effectiveness. Patients also received waiver of out-of-pocket expenses for diabetes care.
EMPOWER	Experimental	Behavioral: Pharmacist CounselingPatients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items. Patients also received waiver of out-of-pocket expenses for diabetes care.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

diabetes (Type I or Type II)
enrolled in health plan with participating employer
age 18 or older
willing and able to provide informed consent

Key exclusion criteria (1 listed)

gestational diabetes

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
Pharmacist CounselingPatients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items. Patients also received waiver of out-of-pocket expenses for diabetes care.	Behavioural	EMPOWER
Educational materialsPatients received educational materials (handouts) in the mail. This was assumed to be of minimal effectiveness. Patients also received waiver of out-of-pocket expenses for diabetes care.	Behavioural	Usual Care plus out-of-pocket cost waiver

Primary outcome

Change in Hemoglobin A-1C From Baseline
Time frame: baseline and 12 months
Compare changes in Hemoglobin A-1C from baseline between the two groups.

3 secondary outcomes

Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides
Time frame: baseline and 12 months
Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months
Time frame: baseline to 12 months
Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months
Time frame: From baseline to 12 months

Results and safety

Results posted to the registry on 22 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care Plus Out-of-pocket Cost Waiver	32	31
EMPOWER Group	37	36

Primary outcome: Change in Hemoglobin A-1C From Baseline

Time frame: baseline and 12 months. Mean (Standard Deviation). Unit: percentage of glycolsylated hemoglobin

Measure	Usual Care Plus Out-of-pocket Cost Waiver n = 29	Pharmacists Consults Plus Out-of-pocket Cost Waiver n = 36
Value	-0.16 (0.42)	-0.50 (0.50)

Usual Care Plus Out-of-pocket Cost Waiver vs Pharmacists Consults Plus Out-of-pocket Cost Waiver: p = 0.0757, ANCOVA

Population analysed: Specific employers were recruited and offered waiver of out-of-pocket costs for diabetes-related care to their employees to participate in the study. The number of participants reported reflects only those participants who had both baseline and 12-month lab tests.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Follow-up of approximately one year post-randomization (about 400 days, on average). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care Plus Out-of-pocket Cost Waiver	0 of 31 (0%)	0 of 31 (0%)	Not reported
EMPOWER Group	0 of 36 (0%)	0 of 36 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21987530Kraemer DF, Kradjan WA, Bianco TM, Low JA. A randomized study to assess the impact of pharmacist counseling of employer-based health plan beneficiaries with diabetes: the EMPOWER study. J Pharm Pract. 2012 Apr;25(2):169-79. doi: 10.1177/0897190011418513. Epub 2011 Oct 10.
Individual participant dataSharing planned: No

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.

Dale F Kraemer, Ph.D. principal investigator

Oregon State University, College of Pharmacy

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pharmacist Counseling and Educational materials in people with Type I or Type II Diabetes (Excludes Gestational Diabetes), run by Oregon State University.

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 4 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: finished, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Hemoglobin A-1C From Baseline (time frame: baseline and 12 months). 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 NCT00254501, which also lists 1 linked publication.

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 Jul 2016.