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DiabetesPhase 2NCT00263835

A Self-care Intervention for Latino Adults With Diabetes

A Phase 2 study testing Empowerment in people with Diabetes and Hypertension, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

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

The purpose of this study is to modify and evaluate a culturally appropriate intervention that is designed to improve diabetes self-care practices by enhancing the self-efficacy, empowerment and diabetes knowledge among Latino adults over the age of 55 years. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes, Hypertension
What is being tested?
Empowerment
How many people
300 participants
Where
No sites listed yet
Study dates
Oct 2004to May 2006
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 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Self-Identify as having diabetes, be 55 years of age or older, Latino/a and have a hemoglobing A1c of 8% or greater.

Who cannot join

  • Non diabetic, under 55, non Latino/a, a hemoglobin A1c of less than 8%.

About this study

The purpose of this study is to modify and evaluate a culturally appropriate intervention that is designed to improve diabetes self-care practices by enhancing the self-efficacy, empowerment and diabetes knowledge among Latino adults over the age of 55 years.

Read the detailed description

It is recognized that Latinos with diabetes experience substantially worse process and outcomes of care. To address this problem, the goal of the proposed study is to modify and evaluate a culturally appropriate intervention designed to improve diabetes self-care practices by enhancing the self-efficacy, empowerment, and diabetes-specific knowledge among Latino adults over the age of 55 years. Specific aims of the project are: 1) to modify an existing empowerment intervention to improve self-care skills among Latinos with diabetes; 2) to test the effect of a patient-centered culturally-tailored intervention that focuses on increasing self-efficacy, knowledge about diabetes care, and self-care skills among Latinos with diabetes on: a) biophysiological endpoints such as glycemic control; b) self-efficacy, diabetes-specific knowledge, and self-care behaviors; c) psychosocial endpoints such as quality of life; and d) total costs and cost-effectiveness of care; and 3) to test the effect of the intervention on compliance with indicators of good process of diabetes care. To evaluate the effectiveness of the intervention, the research team will conduct a controlled clinical trial that will randomize 300 Latino adults over the age of 55 years with diabetes who are cared for in 4 public clinics affiliated with the Martin Luther King/Drew University Medical Center. Randomization will occur at the patient level. The primary endpoints for the trial will be: 1) differences in glycemic control as reflected by mean difference in hemoglobin A1c over time for the intervention versus usual care control group; and 2) difference in diabetes-specific quality of life over time. The trial will also measure a number of important secondary endpoints both before and after exposure to the intervention: self-efficacy, knowledge about diabetes, self-care behaviors, diabetes-specific symptoms, quality of life, low density lipoprotein levels, blood pressure, weight, quality of care, and costs. Variables that are likely to modify the effectiveness of the intervention will also be examined, including acculturation, language, insurance status, and social support. These data will provide the needed information to evaluate both the effectiveness and the cost effectiveness of the patient-centered intervention among Latino adults with diabetes. In summary, by modifying and testing an empowerment intervention that focuses on the patient, we hope to arm Latino adults with diabetes with the needed self-efficacy, knowledge, and self-care skills to have the best possible glycemic control and process of health care regardless of the resources available in their care setting.

Being tested
Empowerment
Medical subject headings
Diabetes Mellitus, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmpowermentBehavioural

What is being measured

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

  1. Change in hemoglobin A1c.

Secondary outcomes (1)
  1. Change in blood pressure, cholesterol, and weight.

Timeline

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

  1. First posted9 Dec 2005 (estimated)
  2. Study startOct 2004
  3. Study completionMay 2006

Resources

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
Single group
Masking
None (open label)
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00263835
Sponsor's protocol ID
DK59527 (completed)
Other IDs
5R01DK059527-04
Status last verified
Mar 2010
First submitted
7 Dec 2005
Last updated
2 Mar 2010
Results posted
No

Publications

  • Sugiyama T, Steers WN, Wenger NS, Duru OK, Mangione CM. Effect of a community-based diabetes self-management empowerment program on mental health-related quality of life: a causal mediation analysis from a randomized controlled trial. BMC Health Serv Res. 2015 Mar 22;15:115. doi: 10.1186/s12913-015-0779-2.

    PubMed 25880234

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Empowerment in people with Diabetes and Hypertension, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

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: finished, as of the sponsor's last update on 2 Mar 2010. 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 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 hemoglobin A1c.. 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 NCT00263835, 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 2 Mar 2010.

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