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      Study protocol: Couples Partnering for Lipid Enhancing Strategies (CouPLES) – a randomized, controlled trial

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          Abstract

          Background

          Almost 50% of Americans have elevated low-density lipoprotein cholesterol (LDL-C). The behaviors required to lower LDL-C levels may be difficult to adhere to if they are inconsistent with spouses' health practices, and, alternatively, may be enhanced by enlisting support from the spouse. This trial extends previous trials by requiring spouse enrollment, teaching spouses how to provide emotional and instrumental support, allowing patients to decide which component of the intervention they would like to receive, and having patients determine their own goals and action plans.

          Methods

          Veteran outpatients with above-goal LDL-C (N = 250) and their spouses are randomized, as a couple, to receive printed education materials only or the materials plus an 11-month, nurse-delivered, telephone-based intervention. The intervention contains four modules: medication adherence, diet, exercise, and patient-physician communication. Patients decide which modules they complete and in which order; modules may be repeated or omitted. Telephone calls are to patients and spouses separately and occur monthly. During each patient telephone call, patients' progress is reviewed, and patients create goals and action plans for the upcoming month. During spouse telephone calls, which occur within one week of patient calls, spouses are informed of patients' goals and action plans and devise strategies to increase emotional and instrumental support.

          The primary outcome is patients' LDL-C, measured at baseline, 6 months, and 11 months. Linear mixed models will be used to test the primary hypothesis that an 11-month, telephone-based patient-spouse intervention will result in a greater reduction in LDL-C as compared to printed education materials. Various process measures, including social support, self-efficacy, medication adherence, dietary behavior, and exercise, are also assessed to explain any change, or lack thereof, in LDL-C.

          Discussion

          Given the social context in which self-management occurs, interventions that teach spouses to provide instrumental and emotional support may help patients initiate and adhere to behaviors that lower their LDL-C levels. Moreover, allowing patients to retain autonomy by deciding which behaviors they would like to change and how may improve adherence and clinical outcomes.

          Trial Registration

          The ClinicalTrials.gov registration number is NCT00321789.

          Related collections

          Most cited references 24

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          Validation of the Framingham coronary heart disease prediction scores: results of a multiple ethnic groups investigation.

          The Framingham Heart Study produced sex-specific coronary heart disease (CHD) prediction functions for assessing risk of developing incident CHD in a white middle-class population. Concern exists regarding whether these functions can be generalized to other populations. To test the validity and transportability of the Framingham CHD prediction functions per a National Heart, Lung, and Blood Institute workshop organized for this purpose. Sex-specific CHD functions were derived from Framingham data for prediction of coronary death and myocardial infarction. These functions were applied to 6 prospectively studied, ethnically diverse cohorts (n = 23 424), including whites, blacks, Native Americans, Japanese American men, and Hispanic men: the Atherosclerosis Risk in Communities Study (1987-1988), Physicians' Health Study (1982), Honolulu Heart Program (1980-1982), Puerto Rico Heart Health Program (1965-1968), Strong Heart Study (1989-1991), and Cardiovascular Health Study (1989-1990). The performance, or ability to accurately predict CHD risk, of the Framingham functions compared with the performance of risk functions developed specifically from the individual cohorts' data. Comparisons included evaluation of the equality of relative risks for standard CHD risk factors, discrimination, and calibration. For white men and women and for black men and women the Framingham functions performed reasonably well for prediction of CHD events within 5 years of follow-up. Among Japanese American and Hispanic men and Native American women, the Framingham functions systematically overestimated the risk of 5-year CHD events. After recalibration, taking into account different prevalences of risk factors and underlying rates of developing CHD, the Framingham functions worked well in these populations. The sex-specific Framingham CHD prediction functions perform well among whites and blacks in different settings and can be applied to other ethnic groups after recalibration for differing prevalences of risk factors and underlying rates of CHD events.
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            The Self-Administered Comorbidity Questionnaire: a new method to assess comorbidity for clinical and health services research.

            To develop the Self-Administered Comorbidity Questionnaire (SCQ) and assess its psychometric properties, including the predictive validity of the instrument, as reflected by its association with health status and health care utilization after 1 year. A cross-sectional comparison of the SCQ with a standard, chart abstraction-based measure (Charlson Index) was conducted on 170 inpatients from medical and surgical care units. The association of the SCQ with the chart-based comorbidity instrument and health status (short form 36) was evaluated cross sectionally. The association between these measures and health status and resource utilization was assessed after 1 year. The Spearman correlation coefficient for the association between the SCQ and the Charlson Index was 0.32. After restricting each measure to include only comparable items, the correlation between measures was stronger (Spearman r = 0.55). The SCQ had modest associations with measures of resource utilization during the index admission, and with health status and resource utilization after 1 year. The SCQ has modest correlations with a widely used medical record-based comorbidity instrument, and with subsequent health status and utilization. This new measure represents an efficient method to assess comorbid conditions in clinical and health services research. It will be particularly useful in settings where medical records are unavailable.
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              Chronic disease self-management program: 2-year health status and health care utilization outcomes.

              To assess the 1- and 2-year health status, health care utilization and self-efficacy outcomes for the Chronic Disease Self-Management Program (CDSMP). The major hypothesis is that during the 2-year period CDSMP participants will experience improvements or less deterioration than expected in health status and reductions in health care utilization. Longitudinal design as follow-up to a randomized trial. Community. Eight hundred thirty-one participants 40 years and older with heart disease, lung disease, stroke, or arthritis participated in the CDSMP. At 1- and 2-year intervals respectively 82% and 76% of eligible participants completed data. Health status (self-rated health, disability, social/role activities limitations, energy/fatigue, and health distress), health care utilization (ER/outpatient visits, times hospitalized, and days in hospital), and perceived self-efficacy were measured. Compared with baseline for each of the 2 years, ER/outpatient visits and health distress were reduced (P <0.05). Self-efficacy improved (P <0.05). The rate of increase is that which is expected in 1 year. There were no other significant changes. A low-cost program for promoting health self-management can improve elements of health status while reducing health care costs in populations with diverse chronic diseases.
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                Author and article information

                Journal
                Trials
                Trials
                BioMed Central
                1745-6215
                2009
                6 February 2009
                : 10
                : 10
                Affiliations
                [1 ]Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, North Carolina, USA
                [2 ]Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA
                [3 ]Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina, USA
                [4 ]Department of Health Policy and Administration, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
                Article
                1745-6215-10-10
                10.1186/1745-6215-10-10
                2652451
                19200384
                Copyright © 2009 Voils et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                Categories
                Study Protocol

                Medicine

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