Adaptation of a Cognitive Training Intervention for Diabetes Self-Management
2017년 7월 14일 업데이트: 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.
연구 개요
상태
알려지지 않은
상세 설명
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.
연구 유형
중재적
등록 (실제)
29
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
40년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Diabetes Self-Care Activities
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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General Self-Efficacy Scale
기간: Baseline and immediately post-intervention
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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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Heather E Cuevas, PhD, The University of Texas at Austin
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 9월 2일
기본 완료 (실제)
2017년 6월 10일
연구 완료 (예상)
2017년 10월 1일
연구 등록 날짜
최초 제출
2017년 7월 12일
QC 기준을 충족하는 최초 제출
2017년 7월 14일
처음 게시됨 (실제)
2017년 7월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 7월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 7월 14일
마지막으로 확인됨
2017년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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