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Adaptation of a Cognitive Training Intervention for Diabetes Self-Management

14 juli 2017 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

29

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: 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.
Beteende: Memory, Attention, and Problem Solving Skills for Diabetes
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Diabetes Self-Care Activities
Tidsram: Baseline and immediately post-intervention
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.
Baseline and immediately post-intervention

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
General Self-Efficacy Scale
Tidsram: 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."
Baseline and immediately post-intervention
Multifactorial Memory Questionnaire
Tidsram: Baseline and immediately post-intervention
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).
Baseline and immediately post-intervention
Change in executive function
Tidsram: Baseline and immediately post-intervention
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).
Baseline and immediately post-intervention
Center for Epidemiologic Studies Depression Scale
Tidsram: Baseline and immediately post-intervention
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.
Baseline and immediately post-intervention

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Texas at Austin

Utredare

  • Huvudutredare: Heather E Cuevas, PhD, The University of Texas at Austin

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 september 2016

Primärt slutförande (Faktisk)

10 juni 2017

Avslutad studie (Förväntat)

1 oktober 2017

Studieregistreringsdatum

Först inskickad

12 juli 2017

Först inskickad som uppfyllde QC-kriterierna

14 juli 2017

Första postat (Faktisk)

18 juli 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 juli 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 juli 2017

Senast verifierad

1 juli 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2016-08-0001

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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