Promoting Medication Adherence Among Older Adults With Hypertension
15 de outubro de 2020 atualizado por: Marie Krousel-Wood, Tulane University School of Medicine
Overcoming Immunity to Change: A Feasibility Study of a New Method to Promote Medication Adherence Among Older Adults With Hypertension
Over 70% of US adults 65 or older are diagnosed with hypertension, the leading cause of cardiovascular disease and premature deaths in the world. Despite availability of effective drugs to control blood pressure, uncontrolled blood pressure and low adherence to antihypertensive drugs persist as major public health and clinical challenges. On average, 50% of adults adhere to chronic disease medications and lower levels of adherence are associated with worse blood pressure control and adverse outcomes. Many barriers to adherence are well known and have been targeted in interventions to improve medication adherence. As of yet, no single intervention has emerged as superior or even particularly effective in improving adherence. The investigators have recently identified unconscious, self-protective 'hidden motives' that contribute to nonadherence to chronic disease medications. There is a critical need to expand on this insight to test the potential for targeting individuals' 'hidden motives' for low adherence using an innovative learning process called Immunity-to-Change.
As a critical step in testing this intervention to target these 'hidden motives', the investigators will undertake a pilot study to assess the feasibility and acceptability of the Overcoming Immunity-to-Change intervention and determine effect sizes of the intervention on adherence, blood pressure (BP) control, and quality of life (QOL). The investigators will test the Immunity-to-Change intervention in a sample of nonadherent older adults with hypertension (n=18). Another sample of nonadherent older adults with hypertension will be monitored for comparison (n=18).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
36
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
55 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Men and women ages 55 and older, with the goal of a sex- and race-balanced sample
- Diagnosis of essential hypertension
- Uncontrolled hypertension
- Current treatment with antihypertensive medication
- Low antihypertensive pharmacy refill
- English speaking
- Telephone access
- Ability to read print on a computer screen and use the computer keyboard
- Written consent to participate and HIPAA authorization
- Written acceptance of study contract
- Approval of health care provider
Exclusion Criteria:
- Cognitive impairment
- Enrollment in another clinical trial
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Cuidados usuais
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Experimental: Health coaching
Two-hour in-person group counseling session led by health coach, involving development of personalized immunity maps that lay out adherence goal, behaviors that distract from goal, hidden motives that compete with achieving goal, and underlying assumptions Eight 50-minute individual telephone counseling sessions every three weeks with a health coach, focusing on uncovering hidden motives and challenging assumptions with the goal of overturning nonadherence mindsets |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in medication adherence (PDC)
Prazo: Baseline to 6 months
|
Change in proportion of days covered (PDC) from baseline to 6 months
|
Baseline to 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in medication adherence (MMAS-8)
Prazo: Baseline to 6 months
|
Change in MMAS-8 score from baseline to 6 months
|
Baseline to 6 months
|
|
Change in medication adherence (KWood-4)
Prazo: Baseline to 6 months
|
Change in KWood-4 score from baseline to 6 months
|
Baseline to 6 months
|
|
Change in medication adherence (MMAS-8)
Prazo: Baseline to 3 months
|
Change in MMAS-8 score from baseline to 3 months
|
Baseline to 3 months
|
|
Change in medication adherence (KWood-4)
Prazo: Baseline to 3 months
|
Change in KWood-4 score from baseline to 3 months
|
Baseline to 3 months
|
|
Change in proportion with low adherence (PDC)
Prazo: Baseline to 6 months
|
Change in proportion with low adherence (PDC<0.8)
from baseline to 6 months
|
Baseline to 6 months
|
|
Change in proportion with low adherence (MMAS-8)
Prazo: Baseline to 6 months
|
Change in proportion with low adherence (MMAS-8<6) from baseline to 6 months
|
Baseline to 6 months
|
|
Change in proportion with low adherence (KWood-4)
Prazo: Baseline to 6 months
|
Change in proportion with low adherence (KWood-4>0) from baseline to 6 months
|
Baseline to 6 months
|
|
Change in proportion with low adherence (MMAS-8)
Prazo: Baseline to 3 months
|
Change in proportion with low adherence (MMAS-8<6) from baseline to 3 months
|
Baseline to 3 months
|
|
Change in proportion with low adherence (KWood-4)
Prazo: Baseline to 3 months
|
Change in proportion with low adherence (KWood-4>0) from baseline to 3 months
|
Baseline to 3 months
|
|
Change in systolic blood pressure
Prazo: Baseline to 6 months
|
Change in systolic blood pressure from baseline to 6 months
|
Baseline to 6 months
|
|
Change in diastolic blood pressure
Prazo: Baseline to 6 months
|
Change in diastolic blood pressure from baseline to 6 months
|
Baseline to 6 months
|
|
Change in systolic blood pressure
Prazo: Baseline to 3 months
|
Change in systolic blood pressure from baseline to 3 months (if available from insurance records)
|
Baseline to 3 months
|
|
Change in diastolic blood pressure
Prazo: Baseline to 3 months
|
Change in diastolic blood pressure from baseline to 3 months (if available from insurance records)
|
Baseline to 3 months
|
|
Change in proportion with controlled blood pressure
Prazo: Baseline to 6 months
|
Change in proportion with controlled blood pressure (SBP<140 & DBP<90) from baseline to 6 months
|
Baseline to 6 months
|
|
Change in proportion with controlled blood pressure
Prazo: Baseline to 3 months
|
Change in proportion with controlled blood pressure (SBP<140 & DBP<90) from baseline to 3 months
|
Baseline to 3 months
|
|
Change in health-related quality of life
Prazo: Baseline to 6 months
|
Change in health-related quality of life score (SF-36) from baseline to 6 months
|
Baseline to 6 months
|
|
Change in health-related quality of life
Prazo: Baseline to 3 months
|
Change in health-related quality of life score (SF-36) from baseline to 3 months
|
Baseline to 3 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in hidden motives score
Prazo: Baseline to 6 months
|
Change in hidden motives score from baseline to 6 months
|
Baseline to 6 months
|
|
Change in hidden motives score
Prazo: Baseline to 3 months
|
Change in hidden motives score from baseline to 3 months
|
Baseline to 3 months
|
|
Change in explicit attitudes score
Prazo: Baseline to 6 months
|
Change in explicit attitudes score (Beliefs about Medicines Questionnaire) from baseline to 6 months
|
Baseline to 6 months
|
|
Change in explicit attitudes score
Prazo: Baseline to 3 months
|
Change in explicit attitudes score (Beliefs about Medicines Questionnaire) from baseline to 3 months
|
Baseline to 3 months
|
|
Change in implicit attitudes score
Prazo: Baseline to 6 months
|
Change in implicit attitudes score (d-score from single-category implicit association test) from baseline to 6 months
|
Baseline to 6 months
|
|
Change in explicit ambivalence score
Prazo: Baseline to 6 months
|
Change in explicit ambivalence score (absolute value of difference between standardized positive and negative explicit attitudes scores) from baseline to 6 months
|
Baseline to 6 months
|
|
Change in explicit ambivalence score
Prazo: Baseline to 3 months
|
Change in explicit ambivalence score (absolute value of difference between standardized positive and negative explicit attitudes scores) from baseline to 3 months
|
Baseline to 3 months
|
|
Change in implicit ambivalence score
Prazo: Baseline to 6 months
|
Change in implicit ambivalence score (absolute value of difference between standardized explicit and implicit attitude scores)
|
Baseline to 6 months
|
|
Change in short risk aversion switch point
Prazo: Baseline to 6 months
|
Change in short switch point on risk aversion scale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in short risk aversion switch point
Prazo: Baseline to 3 months
|
Change in short switch point on risk aversion scale from baseline to 3 months
|
Baseline to 3 months
|
|
Change in long risk aversion switch point
Prazo: Baseline to 6 months
|
Change in long switch point on risk aversion scale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in long risk aversion switch point
Prazo: Baseline to 3 months
|
Change in long switch point on risk aversion scale from baseline to 3 months
|
Baseline to 3 months
|
|
Change in risk valuation
Prazo: Baseline to 6 months
|
Change in value indicated on risk aversion scale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in risk valuation
Prazo: Baseline to 3 months
|
Change in value indicated on risk aversion scale from baseline to 3 months
|
Baseline to 3 months
|
|
Change in medication-taking self-efficacy (MUSE)
Prazo: Baseline to 6 months
|
Change in score on MUSE medication-taking subscale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in medication-taking self-efficacy (MUSE)
Prazo: Baseline to 3 months
|
Change in score on MUSE medication-taking subscale from baseline to 3 months
|
Baseline to 3 months
|
|
Change in learning-about-medications self-efficacy (MUSE)
Prazo: Baseline to 6 months
|
Change in score on MUSE learning-about-medications subscale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in learning-about-medications self-efficacy (MUSE)
Prazo: Baseline to 3 months
|
Change in score on MUSE learning-about-medications subscale from baseline to 3 months
|
Baseline to 3 months
|
|
Change in self-efficacy (MUSE)
Prazo: Baseline to 6 months
|
Change in score on MUSE scale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in self-efficacy (MUSE)
Prazo: Baseline to 3 months
|
Change in score on MUSE scale from baseline to 3 months
|
Baseline to 3 months
|
|
Change in self-efficacy (Self-Efficacy for Managing Chronic Disease)
Prazo: Baseline to 6 months
|
Change in score on SEMCD scale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in self-efficacy (Self-Efficacy for Managing Chronic Disease)
Prazo: Baseline to 3 months
|
Change in score on SEMCD scale from baseline to 3 months
|
Baseline to 3 months
|
|
Change in chronic stress
Prazo: Baseline to 6 months
|
Change in chronic stress from baseline to 6 months, as measured by salivary cortisol
|
Baseline to 6 months
|
|
Change in perceived stress
Prazo: Baseline to 6 months
|
Change in score on 4-item version of Perceived Stress Scale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in perceived stress
Prazo: Baseline to 3 months
|
Change in score on 4-item version of Perceived Stress Scale from baseline to 3 months
|
Baseline to 3 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Marie A Krousel-Wood, MD MSPH, Tulane University
- Diretor de estudo: Erin M Peacock, PhD MPH, Tulane University
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de outubro de 2016
Conclusão Primária (Real)
30 de dezembro de 2019
Conclusão do estudo (Real)
30 de dezembro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
24 de maio de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de julho de 2016
Primeira postagem (Estimativa)
27 de julho de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de outubro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de outubro de 2020
Última verificação
1 de outubro de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 735133
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Não
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