- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00321789
A Patient-Spouse Intervention for Self-Managing High Cholesterol (CouPLES)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Background: Background/Rationale: Coronary heart disease (CHD) is the leading cause of death in the United States, resulting in more than 500,000 heart attacks and another 500,00 deaths per year. More than 80% of veterans have > 2 risk factors for CHD, underscoring the need for intervention. One major modifiable risk factor for CHD is elevated low-density lipoprotein cholesterol (LDL-C). Despite the proven success of diet, exercise, and medication, LDL-C frequently is not at the optimum level, due in part to patient nonadherence. Therefore, interventions are needed to increase adherence, thereby lowering LDL-C.
Objectives: Objectives: We examined the effect of a patient-spouse intervention to lower LDL-C by increasing patient treatment adherence. The primary hypothesis was that patients enrolled in a telephone-based, spouse-assisted intervention will experience a clinically meaningful 7% reduction in LDL-C. The secondary hypotheses were that patients who receive the intervention would show a significant increase in adherence to medication, diet, and exercise.
Methods: In a 3-year study, a randomized controlled trial compared a 10-month, telephone-based, spouse-assisted intervention to usual care. Married patients with above-goal LDL-C and their spouses were consented, completed a baseline assessment, and then were randomly assigned to the intervention or usual care arm. Month 1 involved an educational call delivered to patients and spouses. Months 2-10 (except month 6) involved monthly goal setting calls delivered to patients and calls focused on increasing social support to spouses. The patient phone call will always preceded the spouse phone call. At 6 and 11 months, LDL-C and adherence were re-assessed. The primary outcome was LDL-C measured three times (baseline, 6 months, 11 months); secondary outcomes were adherence to medication, diet, and exercise, also assessed at baseline, 6 months, and 11 months. Descriptive statistics were computed for all study variables within each study arm. Mixed effects models were used to evaluate the intervention's effect on the primary and secondary outcomes at 11 months. We also calculated intervention cost.
Status: Enrollment began in Fall, 2007 and was completed in July of 2009.
Impact: Elevated LDL-C is a major risk factor for CHD, stroke, and peripheral vascular disease, all of which are common among veterans. The expected increase in prevalence of CHD over the next several decades will result in an increased burden for both veterans and the VA health care system. Despite the known risk of hypercholesterolemia, many veterans have suboptimal LDL-C levels. As the latest evidence and recommendations suggest that these goals should be even lower, interventions to assist patients to lower LDL-C increasingly will be needed. The VA considers the reduction of LDL-C an important goal, as indicated by the major effort of the Ischemic Heart Disease Quality Enhancement Research Initiatives (QUERI). This study is important because (1) it addresses a highly prevalent risk factor for CHD among veterans; (2) it proposes a potentially low-cost method for improving LDL-C levels, which in turn could reduce VA healthcare costs; (3) the intervention is practical and could be disseminated easily in the VA healthcare system if proven effective; and (4) this intervention provides a model for self-management of other chronic diseases, such as diabetes and hypertension.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
North Carolina
-
Durham, North Carolina, Estados Unidos, 27705
- Durham VA Medical Center, Durham, NC
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- veteran
- elevated baseline low-density lipoprotein cholesterol level
- married
Exclusion Criteria:
- no telephone number;
- spouse unwilling to participate;
- patient or spouse cognitively impaired, unable to communicate via telephone, living in nursing home or receiving home health care, or refuses to provide informed consent;
- hospitalized past 3 months;
- survival prognosis less than 1 year;
- active psychosis or dementia; no primary care physician at VA;
- no medical visit to VA in past year;
- enrolled in another study focusing on lifestyle changes
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Spouse-assisted intervention
Couples assigned to this arm received nine monthly phone calls from a nurse.
The patient created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence.
The spouse developed a plan to support patient goal achievement.
|
Couples assigned to this arm received nine monthly phone calls from a nurse.
The patient created monthly goals and action plans related to diet, exercise, patient-provider communication, or medication adherence.
The spouse created plans to support patient goal achievement.
|
Sem intervenção: Usual care
Couples assigned to this arm received educational materials at baseline and usual care thereafter, with no contact from the study interventionist.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Low-density Lipoprotein Cholesterol
Prazo: 11-month follow-up
|
assessed with non-fasting blood test
|
11-month follow-up
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Caloric Intake
Prazo: 11-month follow-up
|
Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
|
11-month follow-up
|
Saturated Fat (Grams/Day)
Prazo: 11-month follow-up
|
Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
|
11-month follow-up
|
Total Fat (Grams/Day)
Prazo: 11-month follow-up
|
Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
|
11-month follow-up
|
Cholesterol Intake
Prazo: 11-month follow-up
|
Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
|
11-month follow-up
|
Fiber Intake
Prazo: 11-month follow-up
|
Self-reported, assessed via Block Brief Food Frequency Questionnaire.
|
11-month follow-up
|
Frequency of Moderate Intensity Physical Activity
Prazo: 11-month follow-up
|
Self-reported via Community Health Activities Model Program for Seniors questionnaire.
|
11-month follow-up
|
Duration of Moderate Intensity Physical Activity
Prazo: 11-month follow-up
|
Self-reported via Community Health Activities Model Program for Seniors questionnaire.
|
11-month follow-up
|
Total Fat (%)
Prazo: 11-month follow-up
|
Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
|
11-month follow-up
|
Saturated Fat (%)
Prazo: 11-month follow-up
|
Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
|
11-month follow-up
|
Number of Participants With Goal LDL-C
Prazo: 11-month follow-up
|
Assessed via non-fasting blood test.
Goal is determined by 2003 National Cholesterol Education Program guidelines.
Goal could be 160mg/dL for low risk (no coronary heart disease (CHD), 0-1 risk factor); 130 mg/dL for medium risk (no CHD, at least 2 risk factors); or 100 mg/dL for high risk (CHD and risk equivalents including diabetes, atherosclerotic disease, and multiple risk factors that confer a 10-year risk for CHD >20% per Framingham score).
|
11-month follow-up
|
Number of Participants Prescribed Cholesterol Medication
Prazo: 11-month follow-up
|
This was assessed via electronic medical record abstraction.
Results could not be modeled statistically due to missing data/small cell sizes (i.e., not all participants had a prescription for medication because this was not an inclusion criterion).
|
11-month follow-up
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Corrine I. Voils, PhD, Durham VA Medical Center, Durham, NC
Publicações e links úteis
Publicações Gerais
- Voils CI, Yancy WS Jr, Weinberger M, Bolton J, Coffman CJ, Jeffreys A, Oddone EZ, Bosworth HB. The trials and tribulations of enrolling couples in a randomized, controlled trial: a self-management program for hyperlipidemia as a model. Patient Educ Couns. 2011 Jul;84(1):33-40. doi: 10.1016/j.pec.2010.06.005. Epub 2010 Jul 5.
- Voils CI, Yancy WS Jr, Kovac S, Coffman CJ, Weinberger M, Oddone EZ, Jeffreys A, Datta S, Bosworth HB. Study protocol: Couples Partnering for Lipid Enhancing Strategies (CouPLES) - a randomized, controlled trial. Trials. 2009 Feb 6;10:10. doi: 10.1186/1745-6215-10-10.
- Voils CI, Coffman CJ, Yancy WS Jr, Weinberger M, Jeffreys AS, Datta S, Kovac S, McKenzie J, Smith R, Bosworth HB. A randomized controlled trial to evaluate the effectiveness of CouPLES: a spouse-assisted lifestyle change intervention to improve low-density lipoprotein cholesterol. Prev Med. 2013 Jan;56(1):46-52. doi: 10.1016/j.ypmed.2012.11.001. Epub 2012 Nov 9.
- Gallagher P, Yancy WS Jr, Jeffreys AS, Coffman CJ, Weinberger M, Bosworth HB, Voils CI. Patient self-efficacy and spouse perception of spousal support are associated with lower patient weight: baseline results from a spousal support behavioral intervention. Psychol Health Med. 2013;18(2):175-81. doi: 10.1080/13548506.2012.715176. Epub 2012 Sep 10.
- King HA, Jeffreys AS, McVay MA, Coffman CJ, Voils CI. Spouse health behavior outcomes from a randomized controlled trial of a spouse-assisted lifestyle change intervention to improve patient low-density lipoprotein cholesterol. J Behav Med. 2014 Dec;37(6):1102-7. doi: 10.1007/s10865-014-9559-4. Epub 2014 Mar 2.
- Sperber NR, Sandelowski M, Voils CI. Spousal support in a behavior change intervention for cholesterol management. Patient Educ Couns. 2013 Jul;92(1):121-6. doi: 10.1016/j.pec.2013.02.015. Epub 2013 Mar 27.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IIR 05-273
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em spouse-assisted intervention
-
LuciLabCentre de Recherche de l'Institut Universitaire de Geriatrie de Montreal; Sojecci...ConcluídoComportamento de risco | Declínio CognitivoCanadá
-
University of TurkuDesconhecidoSaudável | Comportamento de saúdeFinlândia
-
Henry Ford Health SystemBlue Cross Blue Shield of Michigan FoundationConcluído
-
Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconhecidoInfarto CerebralAlemanha
-
Northwestern UniversityEmory UniversityConcluídoAfasia Progressiva Primária | Esgotamento do cuidadorEstados Unidos
-
Rhode Island HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...ConcluídoCyberbullyingEstados Unidos
-
University of VirginiaConcluídoLesão da medula espinal | Úlceras de pressãoEstados Unidos
-
Charles G. ProberStanford University; Heidelberg University; University of Stellenbosch; University...ConcluídoAleitamento Materno Exclusivo | Práticas de alimentação infantilÁfrica do Sul
-
Borja Alcobía-Díaz MD, PhDRecrutamentoCirurgia protética de joelho | Assistência RobóticaEspanha
-
University of Alabama, TuscaloosaNational Institute of Nursing Research (NINR)ConcluídoDor | Cuidado paliativo | Distúrbios da Retenção Cognitiva | Outra doença crônicaEstados Unidos