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).
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
- Conditions
- Diabetes, Hypertension
- 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.
Change in hemoglobin A1c.
Secondary outcomes (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.
- First posted9 Dec 2005 (estimated)
- Study startOct 2004
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Carol M Mangione, M.D., MSPH, Principal investigator, University of California, Los Angeles
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-care Intervention for Latino Adults With Diabetes
- ClinicalTrials.gov ID
- NCT00263835
- Acronym / sponsor ID
- DK59527 (completed)
- Conditions
- Diabetes, Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Oct 2004
- Study completion
- May 2006
- First posted
- 9 Dec 2005 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self-Identify as having diabetes, be 55 years of age or older, Latino/a and have a hemoglobing A1c of 8% or greater.
Key exclusion criteria (1 listed)
- Non diabetic, under 55, non Latino/a, a hemoglobin A1c of less than 8%.
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 |
|---|---|---|
| Empowerment | Behavioural | – |
Primary outcome
Change in hemoglobin A1c.
1 secondary outcome
Change in blood pressure, cholesterol, and weight.
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 2 Mar 2010.
- Derived from this study: PubMed 25880234Sugiyama 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.
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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.
Carol M Mangione, M.D., MSPH principal investigator
University of California, Los Angeles
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.