Completed

Arthritis Patient Education for Urban African Americans

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Patient self-care education

Behavioral
Who is being recruted

Arthritis

Over 18 Years
+3 Eligibility Criteria
How is the trial designed

Other Study

Interventional
Study Start: September 1997

Summary

Principal SponsorUniversity of Michigan
Last updated: June 11, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 1997Actual date on which the first participant was enrolled.

Research has shown that people with arthritis can improve their ability to cope with arthritis pain with the help of patient education programs, which teach people things they can do to help manage their disease. However, we do not know much about the effects of arthritis patient education programs on minorities, such as urban African Americans. We will gather participants for this project through a faith-based community network. The project is made up of four studies that will provide information about culturally relevant ways of reaching urban African Americans with arthritis and providing patient education that addresses arthritis care needs of the African American community. This project will also provide information on the effectiveness of an arthritis self-help course for urban African Americans. We hope to better understand the differences among cultural groups and how these differences should affect the design of culturally appropriate patient education. Clinical studies have shown that arthritis patient education interventions are an effective addition to medical treatment in improving patients' ability to cope with pain, thereby reducing perceived symptom severity, improving patients' ability to help themselves, and providing them with skills and strategies for dealing with limits on daily activities. We know little, however, about generalizing the effects of such programs to cultural minority groups, such as urban African Americans. We know even less about the longevity of any benefits of patient education or about effective reinforcement and maintenance techniques. To examine these issues, we will recruit participants for this project through a faith-based community network to pursue the following aims: 1. Evaluate the impact of arthritis patient education on arthritis symptoms and pain levels, functional status, self-care knowledge and behaviors, self-efficacy, emotional status, and health care resource use through a randomized controlled trial (Study 1). 2. Test the impact of focused reinforcement of the concepts in the Arthritis Self-Help Course (ASHC) over a 12-month period through a randomized controlled trial (Study 2). 3. Examine the detailed educational dynamics of the ASHC, identify aspects of the course that are less effective with or relevant to African Americans, and identify modes of communication and presentation used in the course that require adaptation for an African American audience (Study 3). 4. Assess the personal and cultural belief systems underlying African Americans' understanding of arthritis and their use of conventional and unconventional arthritis treatments (Study 4). These studies will provide valuable information regarding culturally relevant methods of reaching urban African Americans with arthritis and providing patient education that addresses arthritis care needs of the African American community. This study will also clarify the longevity of educational benefits and the effectiveness of alternative methods of educational reinforcement in this population. The exploratory studies of individual beliefs and knowledge of arthritis and its treatment, and the formal evaluation of a patient education program, will provide a better understanding of the ways in which cultural groups differ and how these differences should influence the design and delivery of culturally appropriate patient education.

Official TitleEvaluating/Reinforcing Arthritis Patient Education for Urban African Americans 
Principal SponsorUniversity of Michigan
Last updated: June 11, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
90 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Arthritis
Criteria
2 inclusion criteria required to participate
Urban African Americans with arthritis

18 years or older

1 exclusion criteria prevent from participating
None
Anonymus Profile Image
Ensure optimum compatibilityAdd your profile to know your probability eligibility score.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Education in Arthritis Self-Help Course
Study Objectives
Primary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of MichiganAnn Arbor, United StatesSee the location

CompletedOne Study Center
Arthritis Patient Education for Urban African Americans | PatLynk