Ignite Creation Date:
2024-05-06 @ 1:24 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04014582
Status:
COMPLETED
Last Update Posted:
2020-05-01
First Post:
2019-06-26
Brief Title:
Taking Action a Care for Type 2 Diabetes Intervention for Couples
Sponsor:
Carnegie Mellon University
Organization:
Carnegie Mellon University
Study Overview
Official Title:
Communal Coping Intervention for Couples With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TACTIC
Brief Summary:
Communal coping consists of the appraisal of a problem as shared and collaboration to manage the problem Among individuals with type 2 diabetes self-report daily diary and observational measures of communal coping have been linked to better relationship and health outcomes While communal coping has been linked to positive adjustment outcomes there are no interventions that incorporate both components of communal coping theory interventions often focus on collaborative strategies but do not emphasize a shared appraisal However focusing on the shared appraisal component of communal coping may be the critical component to affect change The primary goal of this study will be to design an intervention that fosters both a shared appraisal and collaboration in individuals with type 2 diabetes The second goal is to explore two potential mechanisms that may drive the links of the intervention to outcomes-perceived emotional responsiveness and self-efficacy
Detailed Description:
Participants will be 60 couples recruited from a previous research study in which one person has type 2 diabetes We will recruit 60 couples based on power analyses of collaboration based interventions The design will be a two-group pretest-posttest design in which couples will be randomly assigned to one of two conditions communal coping or diabetes education All couples will engage in 1 an in-person session 2 a 7-day daily diary protocol and 3 a phone call follow-up 1 month later All participants will come into the laboratory at Carnegie Mellon University to complete a baseline questionnaire and listen to a brief diabetes education from the American Association of Diabetes Educators Couples in the intervention group will then participate in the communal coping intervention This intervention aims to foster a shared appraisal and collaboration through the discussion of past joint coping education about communal coping eg what it is and why it is beneficial and discussions to foster the perception of diabetes as shared Participants in the intervention group will also create collaborative action plans to increase collaboration-collaborative intentions have been shown to successfully impact health outcomes for patients with type 2 diabetes Couples in the intervention group will also receive two daily text messages-one a general reminder to engage in communal coping and the other one of the collaborative intentions they created during the in-person session
There will be two follow-up periods after this in-person session First all couples will answer daily questionnaires over a 7-day period starting the day after the in-person session The second follow-up will be one month after the daily diary period when couples will receive a follow up phone call to assess how the primary outcomes of interest changed over a longer period of time
There will be two follow-up periods after this in-person session First all couples will answer daily questionnaires over a 7-day period starting the day after the in-person session The second follow-up will be one month after the daily diary period when couples will receive a follow up phone call to assess how the primary outcomes of interest changed over a longer period of time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None