Computerized Intervention of Parental Involvement in Diabetes Care of Their Child
1 de junho de 2017 atualizado por: Deborah Ellis, Ph.D., Wayne State University
Computer-Delivered Motivational Intervention to Improve Teen Diabetes Management
The purpose of this study is to develop an intervention to increase parental motivation for supervision and monitoring youth diabetes care behavior.
The intervention will be tested in three brief session in conjunction with regularly scheduled diabetes clinic visits and delivered through a computer program based in the principles of Motivational Interviewing.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
The study includes a development phase (Phase 1: development of the intervention followed by feasibility testing with 10 youth and 10 parents) and a pilot validation phase [Phase 2: pilot randomized clinical trial (RCT)] using a sample of 90 African American youth transitioning to independent diabetes care and their parents.
In this phase, families will be randomly assigned to one of three study arms: parent motivation for monitoring and youth motivation for diabetes care (arm 1), parent motivation for monitoring and youth information (arm 2) or parent and youth information (arm 3).
In phase 1 (development), youth and their caregivers will complete a one-time research visit where they use the program and provide feedback via a semi-structured interview regarding the usefulness of the content, its user-friendliness and make suggestions for changes to enhance acceptability.
In phase 2 ( RCT), families will complete three intervention plus data collection visits and one additional data collection only visit.
Research visits will be scheduled to coincide with appointments in the diabetes clinic to maximize convenience for families.
Tipo de estudo
Intervencional
Inscrição (Real)
145
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
-
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Wayne State 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
10 anos a 13 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- African American race/ethnicity
- Age: 10 years 0 months - 12 years, 11 months
- Type 1 diabetes mellitus
- Diagnosed at least 6 months
- Patient of Children's Hospital of Michigan Diabetes Clinics
- English fluency, both verbal and written
Exclusion Criteria:
- Psychiatry/psychological diagnoses including cognitive impairment that would prevent the participant from understanding the data collection measures, (i.e. moderate or severe mental retardation) or the following psychiatric diagnoses: autism and schizophrenia. Youth with current suicidal intent are not enrolled until psychiatrically stable.
- Medical diagnoses that would result in atypical diabetes management i.e. cystic fibrosis. Other medical conditions that would not affect diabetes management, such as asthma, do not exclude the participant from study participation.
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: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Active Caregiver and Active Child
Parent & Child Computer-Delivered Motivational Intervention will be delivered to participants.
A brief computer delivered behavior change counseling intervention for parents of children with diabetes to improve monitoring of diabetes care and a brief computer delivered behavior change counseling intervention for children with diabetes to improve completion of daily diabetes care.
|
Motivational Interviewing (MI) is a client-centered, directive method for enhancing intrinsic motivation to change by exploring & resolving ambivalence, with a strong evidence for improving adolescent & adult health behaviors.
Three motivational sessions will be provided by an animated character who delivers the intervention with high fidelity to MI principles.
Small amounts of psychoeducation about potential improvements illness management that can result from monitoring/completing diabetes care will be integrated with more purely motivational elements.
Mailings will be sent to participants to remind them of the reasons they gave as motivation & goals they set regarding diabetes care.
|
|
Experimental: Active Caregiver and Child Education
Parent Computer-Delivered Motivational Intervention will be delivered to the parents only.
A brief computer delivered behavior change counseling intervention for parents of children with diabetes to improve monitoring of diabetes care and a brief computer delivered informational session about diabetes related topics for their child with diabetes.
|
Motivational Interviewing (MI) is a client-centered, directive method for enhancing intrinsic motivation to change by exploring & resolving ambivalence, with a strong evidence for improving adolescent & adult health behaviors.
Three motivational sessions will be provided by an animated character who delivers the intervention with high fidelity to MI principles.
Small amounts of psychoeducation about potential improvements illness management that can result from parental monitoring of diabetes care will be integrated with more purely motivational elements.
Mailings will be sent to participants to remind them of the reasons they gave as motivation & goals they set regarding monitoring diabetes care.
|
|
Comparador Ativo: Education Caregiver/Education Child
Participants will receive computer-delivered information.
A brief computer delivered information session about diabetes related topics for both the caregiver and the child with diabetes.
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Computer-Delivered Information about issues related to living with diabetes that do not directly impact completing diabetes care.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Diabetes Management Scale
Prazo: Each of 3 intervention session, 3-4 month apart
|
The Diabetes Management Scale (DMS) (Frey, Ellis, Naar-King et al., 2004) is a self-report questionnaire used to measure a broad range of diabetes management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision.
|
Each of 3 intervention session, 3-4 month apart
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Treatment Regulation Questionnaire
Prazo: Each of 3 intervention session, 3-4 month apart
|
Parental motivation to monitor the youth is measured by the Treatment Self-Regulation Questionnaire (TSRQ; Ryan & Connell (1989).
The TSRQ evaluates why people engage in a health-relevant behavior and assesses the degree to which one's motivation for a particular behavior or set of behaviors is relatively autonomous or self-determined as compared to derived from external pressures or constraints.
|
Each of 3 intervention session, 3-4 month apart
|
|
Readiness Ruler
Prazo: Each of 3 intervention session, 3-4 month apart
|
Parent motivation to monitor the youth is also measured by the Readiness Ruler (Stott, Rollnick, & Pill, 1995).
Since readiness to change behaviors is behavior specific, the items will be tailored to assess the behaviors most critical to parental monitoring of diabetes management.
The response format is a visual analog scale (VAS) 10 mm in length.
Written cues anchor the ends and middle of the scale.
Respondents mark their "readiness" on the scale and the position on the line is measured in millimeters.
|
Each of 3 intervention session, 3-4 month apart
|
|
HbA1C Blood Test
Prazo: Each of 3 intervention session, 3-4 month apart
|
Metabolic control will be measured via hemoglobin A1c (HbA1c).
HbA1c is an indirect and retrospective measure of average blood glucose levels over the previous two to three month period.
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Each of 3 intervention session, 3-4 month apart
|
|
Parental Monitoring of Diabetes Care
Prazo: Each of 3 intervention session, 3-4 month apart
|
The Parental Monitoring of Diabetes Care scale (PMDC) is an 18 item, investigator-developed questionnaire that measures the frequency of parental monitoring and direct supervision of diabetes care tasks such as insulin administration, blood glucose testing, and dietary management.
|
Each of 3 intervention session, 3-4 month apart
|
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Twenty-four Hour Recall Interview
Prazo: Each of 3 intervention session, 3-4 month apart
|
The Twenty-four Hour Recall Interview, developed by Johnson and colleagues (Freund, Johnson, Silverstein et al., 1991), has been used extensively in pediatric diabetes research for the assessment of illness management.
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Each of 3 intervention session, 3-4 month apart
|
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Blood Glucose Testing Frequency
Prazo: Each of 3 intervention session, 3-4 month apart
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Objective data on mean daily frequency of blood glucose testing during the 14-day period prior to data collection will be obtained directly from blood glucose meters.
|
Each of 3 intervention session, 3-4 month apart
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Deborah A Ellis, Ph.D., Wayne State 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
1 de abril de 2011
Conclusão Primária (Real)
3 de março de 2014
Conclusão do estudo (Real)
9 de setembro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
18 de janeiro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de janeiro de 2012
Primeira postagem (Estimativa)
24 de janeiro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de junho de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de junho de 2017
Última verificação
1 de junho de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 3M's Diabetes Study
- R21DK089238 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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