Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00005724 |
| Other study ID # |
4933 |
| Secondary ID |
R01HL046775 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 25, 2000 |
| Last updated |
April 17, 2017 |
| Start date |
August 1991 |
| Est. completion date |
July 31, 1996 |
Study information
| Verified date |
April 2017 |
| Source |
University of North Carolina, Chapel Hill |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To develop cardiovascular disease nutrition modules tailored to subjects with low literacy
skills.
Description:
BACKGROUND:
The study was part of an NHLBI initiative on "CVD Nutrition Education for Low Literacy
Skills". The initiative originated within the Prevention and Demonstration Branch of the
DECA, was approved by the September 1988 National Heart, Lung, and Blood Advisory Council,
and released in July 1990.
DESIGN NARRATIVE:
The study had three phases. The goal of Phase I was to develop two innovative care modules
that used demographic, psycho-social, nutritional, and behavioral information to
individually tailor nutrition treatment programs for southern patients with less than ninth
grade reading skills. Counselor Directed innovative care consisted of a structured
assessment and intervention package of simply written, graphically-oriented printed
materials to guide the patient and health counselor (nutritionist, health educator, nurse,
or physician). Computer Assisted innovative care used a user-friendly, interactive, computer
assisted program permitting more sophisticated tailoring to individual needs, conveying
nutrition information in a vivid, understandable format, and extending the services of the
health counselor. The investigators used focus groups of patients with low literacy skills
to aid in concept development and refinement of intervention delivery strategies. Reliable
and valid assessments of readability and comprehension helped further refine the materials.
In Phase II, a randomized trial was conducted to determine if the innovative modules
produced a meaningful reduction in cholesterol and overall cardiovascular risk compared to
standard care. Subjects with high cholesterol and low literacy skills served by four
community health centers were randomly assigned to one of four groups: Innovative
Care-Counselor Directed, Innovative Care-Computer Assisted, Standard Care, and Usual Care
for dietary treatment of cholesterol, obesity, and hypertension. Standard Care involved the
same amount of time and health counselor exposure as Innovative Care, but used currently
available materials. Usual Care patients were referred to their usual provider for
treatment. After four months and again at one year, changes in lipids, blood pressure, and
weight were assessed..
Phase Ill consisted of a feasibility study to test the ability of both innovative care
modules to reach low literacy adults through county health departments, worksites, and
churches. Results of the feasibility assessment helped refine a dissemination strategy using
the state health department as a centralized coordinating agency, and county health
departments to implement the interventions at the community level.
