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The Management of Diabetes in Everyday Life Program (MODEL)

8 de outubro de 2019 atualizado por: University of Tennessee

Improving Self-Care Decisions of Medically Underserved African-Americans With Uncontrolled Diabetes: Effectiveness of Patient-Driven Text Messaging Versus Health Coaching

The overall goal of this study is to compare how well motivational messages (text messages from the doctor's office), diabetes health coaches, and enhanced usual care with diabetes education materials (provided at the doctor's office) work to help African-American adults with uncontrolled diabetes improve their diabetes self-care decisions. Self-care is difficult when you have diabetes, especially when patients have other medical conditions, their diabetes is uncontrolled, and when they live in an area without many primary care doctors. Many studies have show that encouraging text messages from the doctor's office and health coaches can help people take better care of themselves. But before primary care clinics around the country start trying to send texts, hire health coaches, or provide additional educational materials it is critical for them to know which approach is more likely to help.

This study will assign African-American diabetics to either text messages, health coaches, or enhanced care to find out which one works better. The investigators especially want to find out if one works better for people at highest risk. Lastly, the investigators want to find out if messages or coaches help people improve their blood sugar, quality of life, and their feelings about primary care.

The study will test messages, coaches, and enhanced care side by side in primary care doctors' offices. The messaging and coaching programs will give patients pretty much the same information, but in different ways. The text messages will be written carefully based on each patient's needs and interests. The coaches will be trained in how to help people get motivated and work to reach their health goals.

This study will include 646 African-American adults, ages 18 and above, with uncontrolled diabetes and one or more additional chronic condition, living in medically underserved communities. People will have to have a cell phone or smart phone with texting capability and be able to use it to participate. 258 participants will get messages, 258 will get coaches, and 130 will receive enhanced care.

The investigators will be able to tell if messages and coaches work by seeing if people improve their diabetes self-care decisions, and if their blood sugar, quality of life, and feelings about primary care get better. The long-term study goal is to get primary care clinics all over the country to start using motivational messages or health coaches if they work well.

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Descrição detalhada

Background and Significance: There is a critical need to determine the comparative effectiveness of text messaging (TM) and health coaching (HC) among African-Americans with uncontrolled diabetes and multiple chronic conditions living in medically underserved areas (MUA) and to identify which modality yields greater improvement in diabetes self-care at-risk urban and rural subpopulations. Although numerous recent studies demonstrate the effectiveness of either TM or HC in improving diabetes and other chronic disease self-care behaviors, and to the knowledge of the investigators no information is available regarding comparative effectiveness of these modalities in urban and rural subgroups. Prevalence of diabetes, related comorbidities, poverty, obesity, food insecurity, and tobacco use is higher in rural areas as compared with urban. Moreover, rural areas struggle to address these needs because of lower access to transportation, primary care, specialty care, diabetes education, and mental health resources. However, urban living has its own unique set of problems-including increased stress and fear for one's physical safety-that may impact the comparative effectiveness of HC and TM. Although there are HC studies that show effectiveness in interventions either in rural or urban areas, there are no HC studies of which the investigators are aware that specifically examine the differences in U.S. rural and urban participants in regards to engagement rates and clinical outcomes from a health coaching intervention. Similarly, telemedicine and mobile health approaches have been particularly advocated for rural populations yet little evidence supports their comparative benefit. The lack of comparative effectiveness of text messaging and health coaching for diabetes self-care in vulnerable urban and rural subgroups represents a critical gap in research that the study is designed to directly address. The study will compare both strategies with enhanced usual care (EC) with diabetes educational materials.

Study Aims: As a result, this research will use a pragmatic randomized trial to determine the comparative effectiveness of patient-driven TM versus HC versus EC for African-American adults with uncontrolled diabetes and multiple chronic conditions in MUA with an emphasis on identifying and quantifying important interactions between key baseline characteristics and treatment arm. Specific aims include: Aim 1-Quantify the effectiveness of TM, HC, and EC in improving the primary outcome measures (diabetes self-care activities related to general diet, exercise and medication adherence); Aim 2-Determine the contributions of six key, baseline patient characteristics: 1) urban vs. rural residence, 2) health literacy, 3) medical complexity, 4) social complexity, 5) smart vs. cell phone ownership, and 6) age, to the comparative effectiveness of TM, HC, and EC; and Aim 3-Quantify the effectiveness of TM, HC, and EC in improving secondary outcomes of average blood sugar, quality of life, and primary care engagement. The long-term objectives are to disseminate and foster implementation of the results of this research in MUA nationwide to improve critical self-care supports in primary care for our most vulnerable populations.

Overall study design: Pragmatic randomized clinical trial.

Main components of the intervention and comparator(s): The study will test two critical strategies for patient engagement that may lead to substantive improvements in the quality of care and outcomes most important to vulnerable patients with diabetes: 1) patient-driven TM, and 2) patient-driven HC. The two parallel primary care-based and patient-driven study interventions (i.e. TM and HC) have been designed to provide approximately the same content, but with two alternative delivery mechanisms. TM will incorporate supportive cognitive behavioral strategies to encourage improved diabetes self-care decisions and will be tailored based on participant demographics, health literacy, preferences, treatment self-regulation, perceived competency and reported barriers to self-care. Motivational interviewing focused HC will aim to meet with participants for individual HC sessions bi-monthly the first 2 months (Intensive Phase-4 sessions following randomization) followed by monthly for remaining 8 months (12 sessions total) to provide support regarding diet/weight loss, physical activity, and medication adherence tailored according to patient-identified health goals. Both strategies will be compared with EC with diabetes educational materials.

Study population: For the main comparative effectiveness analysis (Aim 1) the total sample size (after dropouts) is N=800 with 40% randomized to the TM arm (N1=320), 40% to the HC arm (N2=320), and 20% to the EC arm (N3 = 160). Participants include African-American adults, ages 35-75, with uncontrolled diabetes and multiple chronic conditions, living in medically underserved communities in the MidSouth who have a cell phone or smart phone with texting capability and complete a two-week run-in period demonstrating responsiveness to TM.

Primary/secondary outcomes: The primary outcome measures assessing effectiveness include: three (out of six total) subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessing general diet, exercise, and medication adherence. Secondary outcomes include: diabetes-specific quality of life using the Diabetes-39, primary care engagement using National Health Interview Survey questions regarding delayed needed care, and average blood sugar (A1c) obtained from medical records and reported in the DWPC-R.

Analytic methods: For Aim 1, in the context of repeated measures ANOVA, using t-tests within arm to detect change from baseline to 12-months (Follow-up 3), power exceeds 0.9 for all primary outcomes. For Aim 2, six analyses will assess heterogeneity of treatment effects by evaluating the interaction of each key, dichotomized, baseline characteristic with treatment arm, estimating means and standard errors of six subclasses, and within each characteristic (e.g. low or high health literacy) testing for differences between TM and HC, TM and EC, and HC and TM. Analyses for Aim 3 will be conducted as described above for Aim 1.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

646

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

  • Estados Unidos
    • Mississippi
      • Holly Springs, Mississippi, Estados Unidos, 38635
        • Rescindido
        • Hawkins Family Medicine
    • Tennessee
      • Bartlett, Tennessee, Estados Unidos, 38135
        • Recrutamento
        • Covington Pike Primary Care, Methodist Le Bonheur Healthcare
        • Contato:
      • Covington, Tennessee, Estados Unidos, 38019
        • Ativo, não recrutando
        • Tipton Family Medicine Center
      • Jackson, Tennessee, Estados Unidos, 38301
        • Recrutamento
        • University of Tennessee Family Practice Center
        • Contato:
      • Memphis, Tennessee, Estados Unidos, 38104
        • Recrutamento
        • Eastmoreland Internal Medicine
        • Contato:
        • Contato:
      • Memphis, Tennessee, Estados Unidos, 38104
        • Recrutamento
        • Midtown Internal Medicine, Methodist Le Bonheur Healthcare
        • Contato:
      • Memphis, Tennessee, Estados Unidos, 38104
        • Recrutamento
        • Peabody Family Care, Methodist Le Bonheur Healthcare
        • Contato:
        • Contato:
      • Memphis, Tennessee, Estados Unidos, 38104
        • Recrutamento
        • UT Methodist Physicians, Eastmoreland Endocrinology
        • Contato:
          • Keith Paden
          • Número de telefone: 901-272-7797
      • Memphis, Tennessee, Estados Unidos, 38109
      • Memphis, Tennessee, Estados Unidos, 38116-6442
        • Rescindido
        • TriState Medical Group PLLC
      • Memphis, Tennessee, Estados Unidos, 38116
        • Recrutamento
        • Motley Internal Medicine, Methodist Le Bonheur Healthcare
        • Contato:
        • Contato:
          • Markila Milam
          • Número de telefone: (901) 332-8547
      • Memphis, Tennessee, Estados Unidos, 38116
        • Recrutamento
        • South Internal Medicine, Methodist Le Bonheur Healthcare
        • Contato:
      • Memphis, Tennessee, Estados Unidos, 38116
        • Recrutamento
        • UT Methodist Physicians, South Endocrinology
        • Contato:
        • Contato:
      • Memphis, Tennessee, Estados Unidos, 38119
        • Recrutamento
        • PennMarc Internal Medicine, Methodist Le Bonheur Healthcare
        • Contato:
          • Paul Katz, MD
          • Número de telefone: 901-525-3086
      • Memphis, Tennessee, Estados Unidos, 38122
        • Recrutamento
        • Christ Community Health Services, Broad Avenue Health Center
        • Contato:
      • Memphis, Tennessee, Estados Unidos, 38126
      • Memphis, Tennessee, Estados Unidos, 38128
        • Recrutamento
        • Christ Community Health Center - Raleigh Health Center
        • Contato:
        • Contato:
          • Natalie Burch, PA
          • Número de telefone: 901-485-8509
      • Memphis, Tennessee, Estados Unidos, 38128
        • Recrutamento
        • Whitney Slade Internal Medicine, Methodist Le Bonheur Healthcare
        • Contato:
      • Memphis, Tennessee, Estados Unidos, 38163

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • self-identified African-American adults
  • diagnosis of uncontrolled diabetes (HbA1C > 8)
  • have at least one other of 13 chronic health conditions (hypertension, congestive heart failure, coronary artery disease, cardiac arrhythmias, hyperlipidemia, stroke, arthritis, asthma, cancer, chronic kidney disease, chronic obstructive pulmonary disease, depression, and osteoporosis and excluding dementia)) using the CMS ICD-9-CM-based definitions
  • is receiving or will receive care at one of our identified clinical sites
  • has a cell phone or smart phone with texting and voicemail capabilities
  • is not planning to move from the area in the next year
  • is able to provide informed consent
  • is English speaking
  • completes a two-week run-in period for text message and voice message use

Exclusion Criteria:

  • inability to understand consent procedures
  • Pregnant
  • presence of an unstable psychiatric condition or dementia
  • perceived unwillingness or inability to participate
  • inability to successfully complete the text message and voice message screening test
  • Plans to move from the area and change primary care physicians in the next year.
  • Diagnosis of severe depression in the last six months
  • Individuals with cognitive impairment will be excluded if they experience difficulty either understanding, following directions, or communicating clearly with program staff. Individuals will be excluded if they exhibit uncontrolled psychiatric symptoms and/or behaviors that may present a danger to program staff or to the study participants themselves.

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
Experimental: Text Messaging (TM)
The TM intervention will use an extensive text message library focused on 3 key behavioral areas (diet, exercise, and medication adherence). The TM intervention will incorporate supportive cognitive behavioral strategies such as goal setting, positive reinforcement, self-talk and dealing with barriers to change. Messages will encourage social interaction (social support, problem-solving, and feedback), self-monitoring of diet and exercise, diet modification, physical activity advice and prompting and basic self- regulatory skills. Messages will be tailored based on participant demographics, health literacy, and preferences.
Comportamental: Text Messaging (TM)
As specified in the arm description above
Experimental: Health Coaching (HC)
The HC intervention will place emphasis on the coach establishing rapport with the participant and assessing and establishing their initial goals using motivational interviewing, HC program goals, plans for future individual sessions. A written copy of personal health goals will be given to patients at the end of the first session. Coaches will aim to meet with participants for individual HC sessions bi-monthly the first 2-3 months followed by monthly for 8 - 9 months to provide information and support regarding health habits focusing sessions on areas related to patient-identified health goals, needs, and barriers to change. Sessions can occur in person or by phone based on patient preference.
Comportamental: Health Coaching (HC)
As specified in the arm description above
Comparador Ativo: Enhanced Usual Care (EC)

All participants in all 3 study arms (TM, HC, and EC) will receive enhanced usual care. Usual care in the participating practices will be supplemented through the following key EC resources:

A. Patient-focused Resources including: 1) MODEL Program Toolkit, and 2) low literacy diabetes educational materials.

B. Availability of diabetes support services including: 1) peer group support sessions, 2) diabetes education, 3) MyDiabetesCenter.org resources, and 4) Diabetes Coalition education hub resources.

C. Practice-focused components including: 1) practice training/continuing medical education, and 2) reporting of diabetes performance measures.
Comportamental: Text Messaging (TM)
As specified in the arm description above
Comportamental: Health Coaching (HC)
As specified in the arm description above
Comportamental: Enhanced Usual Care (EC)
As specified in the arm description above

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Diabetes Self-Care Activities
Prazo: 1 year
The Revised Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) assesses DM self-care over the previous 7 days for 7 core behaviors: smoking, diet, exercise, blood sugar testing, foot care, smoking, and medication adherence (12 items)
1 year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Diabetes-Specific Quality of Life
Prazo: 1 year
The Diabetes-39 has 5 domains: DM control, Anxiety and worry, Social burden, Sexual functioning, and Energy and mobility
1 year
Primary Care Engagement
Prazo: 1 year
Selected National Health Interview Survey (NHIS) questions assess 3 primary domains: (a) Usual source of care when sick; (b) Usual source of preventive care; and (c) Delay in needed care
1 year
Quality of Care
Prazo: 1 year
The Patient Assessment of Chronic Illness Care (PACIC) measures specific actions or qualities of care based on Chronic Care Model
1 year
Average Blood Sugar (A1c)
Prazo: 1 year
The Hemoglobin A1c blood test assesses average blood sugar over the past 6 weeks to 3 months
1 year

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Tennessee

Colaboradores

Patient-Centered Outcomes Research Institute

Investigadores

  • Investigador principal: James E Bailey, MD, MPH, University of Tennessee

Publicações e links úteis

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Publicações Gerais

Links úteis

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 novembro de 2016

Conclusão Primária (Antecipado)

31 de dezembro de 2020

Conclusão do estudo (Antecipado)

31 de dezembro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

24 de outubro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de novembro de 2016

Primeira postagem (Estimativa)

6 de novembro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de outubro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de outubro de 2019

Última verificação

1 de julho de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 16-04735-FB
  • SC15-1503-28336 (Número de outro subsídio/financiamento: PCORI)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Data may be exported from the database system that houses study data in a variety of formats for sharing and/or analysis. At study completion, the investigators anticipate extracting all data from the system for sharing with other sources once appropriate governance and sharing restrictions have been addressed. Data dictionaries and associated metadata will be provided as needed upon request. Data can be shipped or mailed in approved, encrypted format or collected via SFTP (secure file transfer protocol) from our servers. The cost of allowing prospective investigators access to the de-identified data from this project will include IRB costs to review the application, salary support to cover staff time to review the concept proposal, submit documents to the IRB, and to establish password-protected and secured transfer application of the data. This cost is per application per investigator who wishes access granted to the de-identified data.

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 .

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