Adaptation of a Cognitive Training Intervention for Diabetes Self-Management
14 de julho de 2017 atualizado por: University of Texas at Austin
The aims of this project are: (1) to refine an existing cognitive rehabilitation intervention and tailor it for persons with T2DM by using current literature and interview data from 10 participants with T2DM and (2) to conduct a feasibility study of the adapted intervention with 20 participants with T2DM.
The intervention consists of 8 weekly group educational sessions to teach compensatory cognitive strategies.
Participants will also use a web-based, game-like program to build on the didactic information and practice activities to improve cognitive health.
Visão geral do estudo
Status
Desconhecido
Intervenção / Tratamento
Descrição detalhada
Type 2 diabetes mellitus (T2DM) increases the risk for cognitive impairment and doubles the rate of cognitive decline after diabetes is diagnosed.
In turn, the presence of cognitive dysfunction can make diabetes self-management more difficult.
Few interventions have attempted to focus on cognitive function in the context of diabetes and none, to date have tested an intervention to improve cognition in order to improve diabetes self-management.
Therefore the aims of this project are: (1) to refine an existing cognitive rehabilitation intervention and tailor it for persons with T2DM by using current literature and interview data from 10 participants with T2DM and (2) to conduct a feasibility study of the adapted intervention with 20 participants with T2DM.
The intervention consists of 8 weekly group educational sessions to teach compensatory cognitive strategies.
Additionally, participants will use a web-based, game-like program to build on the didactic information and practice activities to improve cognitive health.
The project will provide baseline data for further research on diabetes self-management in the context of cognitive dysfunction.
Tipo de estudo
Intervencional
Inscrição (Real)
29
Estágio
- Não aplicável
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
40 anos a 70 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Age 40 to 70
- Have been diagnosed with type 2 diabetes for at least 2 years
- Score of at least 10 on the Perceived Deficits Questionnaire
- Read and write in English
- Have access to transportation and telephone and Internet services
Exclusion Criteria:
- limitations that preclude study activities
- have been diagnosed with dementia or disorders that can affect cognition such as depression
- type 1 diabetes
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: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: Intervention
The intervention includes 4 every other week, 2-hour educational sessions to teach compensatory strategies along with skill development and training.
Educational sessions will include content on common cognitive problems experienced by people with T2DM and discussion of compensatory strategies to improve cognitive skills as well as content on behaviors and lifestyle strategies to maintain cognitive functioning.
Each participant will use the online training program (BrainHQ/Posit Science) for a minimum of 45 minutes 3 times a week and to record practice times and dates.
Tasks in the computer training are arranged so that as the user moves forward, the tasks become more challenging.
Each task is in a game-like format.
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Classes will include: (1) information on diabetes self-management including glucose self-monitoring and medication management; (2) assessment of cognitive problems; (3) resources and barriers to self-management; and (4) lifestyle changes to maximize cognitive health.
Participants will also practice those skills with online computer games.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Diabetes Self-Care Activities
Prazo: Baseline and immediately post-intervention
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Summary of Diabetes Self-Care Activities Questionnaire; 18 items; Participants answer questions regarding how many days in the last week have they performed a certain aspect of diabetes self-management behaviors such as diet, smoking, and physical activity.
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Baseline and immediately post-intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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General Self-Efficacy Scale
Prazo: Baseline and immediately post-intervention
|
10 items; confidence in ability to influence outcomes.
Responses are made on a 4-point scale (1 = not true at all, 2= hardly true, 3 = moderately true, 4= exactly true) to items such as "I can always manage to solve difficult problems If I try hard enough."
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Baseline and immediately post-intervention
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Multifactorial Memory Questionnaire
Prazo: Baseline and immediately post-intervention
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57 items; assesses contentment with one's memory, subjective memory capability, and use of memory aids.
Participants rate their level of agreement with each item on a 5-point scale (strongly agree = 1, agree = 2, undecided = 3, disagree = 4, strongly disagree = 5) for the Contentment subscale; The Ability subscale asks participants to indicate the frequency with which each memory failure has occurred in the past 2 weeks on a 5-point scale (all the time = 1, often =2, sometimes = 3, rarely =4, never =5); The third subscale, Strategy, asks participants to rate the frequency of use of certain memory strategies on a 5-point scale (never =1, rarely =2, sometimes =3, often =4, all the time =5).
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Baseline and immediately post-intervention
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Change in executive function
Prazo: Baseline and immediately post-intervention
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Barkley Deficits in Executive Functioning Scale - Short Form Scale; 20 items assessing the frequency at which participants have exhibited certain behaviors in specific executive functioning areas over the past 6 months.
The areas include: self-management to time, self-organization/problem-solving, self-restraint, self-motivation, and self-regulation of emotion.
Items are measured using a 4-point Likert scale, ranging from never or rarely (1) to very often (4).
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Baseline and immediately post-intervention
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Center for Epidemiologic Studies Depression Scale
Prazo: Baseline and immediately post-intervention
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20 items; measurement of depressive symptoms.
Participants indicate responses on a 4-point item scale from rarely/none of the time to most/all of the time in 8 health dimensions: role limitations due to physical problems, social functioning, physical functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions.
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Baseline and immediately post-intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Heather E Cuevas, PhD, The University of Texas at Austin
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)
2 de setembro de 2016
Conclusão Primária (Real)
10 de junho de 2017
Conclusão do estudo (Antecipado)
1 de outubro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
12 de julho de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de julho de 2017
Primeira postagem (Real)
18 de julho de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de julho de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de julho de 2017
Última verificação
1 de julho de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2016-08-0001
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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