Taking Action: a Care for Type 2 Diabetes Intervention for Couples

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Communal Coping Intervention; Behavioral: Diabetes Education

• Registration Number: NCT04014582
• Lead Sponsor: Carnegie Mellon University

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 (e.g. 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.

Study Timeline

• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-07-09
• Study First Posted: 2019-07-10
• Study Start: 2019-07-20
• Status Verified: 2020-04
• Primary Completion: 2020-04-14
• Study Completion: 2020-04-14
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• One person must have type 2 diabetes.
• Must be married or cohabitating for at least 1 year with a partner
• Must have access to internet to participate (required for daily diary component).

Exclusion Criteria

• Both persons cannot have type 2 diabetes
• Must not have any other major comorbidities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Communal Coping Intervention	Communal Coping Intervention	This group will participate in diabetes education + a communal coping based intervention.
Control	Diabetes Education	This group will participate in diabetes education and an individual intervention.

Primary Outcome Measures

Name	Time	Method
Change in perceived stress	Perceived stress will be measured at baseline and 1 month after the intervention.	Perceived stress will be measured via the 4 item Perceived Stress Scale which ranges from 1 never to 5 very often. Both patients and spouses will complete this self-report questionnaire.
Change in diabetes self-care	Diabetes self-care will be measured at baseline and 1 month after the intervention.	Diabetes self-care will be measured via the summary of diabetes self care activities. Patients will report on their own self care and spouses will report on their perceptions of the patient's self-care. The items in the SDSCA have varying scales based on the question, but higher numbers reflect greater self-care.
Change in relationship satisfaction--PAIR	Relationship satisfaction will be measured at baseline and 1 month after the intervention.	Relationship satisfaction will also be measured via the Personal Assessment of Intimacy in Relationships scale. This scale will be assessed from 1 strongly disagree to 7 strongly agree. Both patients and spouses will complete this questionnaire.
Change in depressive symptoms	Depressive symptoms will be measured at baseline and 1 month after the intervention.	Depressive symptoms will be measured via the 10 item CESD scale which range from 1 none of the time to 4 most of the time. This self-report questionnaire will be assessed for both patient and spouse. Higher numbers represent more depressive symptoms.
Change in life satisfaction	Life satisfaction will be measured at baseline and 1 month after the intervention.	Life satisfaction will be measured via the Satisfaction with Life scale which range from 1 strongly disagree to 7 strongly agree. Higher numbers represent more life satisfaction. Both patients and spouses will report on life satisfaction.
Change in relationship satisfaction--QMI	Relationship satisfaction--QMI will be measured at baseline and 1 month after the intervention.	Relationship satisfaction will be measured via the Quality of Marriage Index. This self-report scale ranges from 1 strongly disagree to 7 strongly agree. Both patients and spouses will complete this self-report questionnaire.

Secondary Outcome Measures

Name	Time	Method
Change in generalized self-efficacy	Self-efficacy will be measured at baseline and 1 month after the intervention.	Self-efficacy will be measured via the new generalized self-efficacy scale. This scale ranges from 1 strongly disagree to 5 strongly agree. Higher numbers reflect greater self-efficacy. Both patients and spouses will report generalized self efficacy.
Change in perceived emotional responsiveness	Perceived emotional responsiveness will be measured at measured at baseline and 1 month after the intervention.	Perceived emotional responsiveness measures the extent to which a spouse feels appropriately supported and understood by the partner. The items used in this scale are modified versions used by Fekete et al. 2007. The scale ranges from 1 not at all to 4 very much. Negative items will be reversed scored so the total scale reflects greater perceived emotional responsiveness for both patients and spouses.
Change in diabetes specific self-efficacy	Self-efficacy will be measured at baseline and 1 month after the intervention.	Self-efficacy will be measured via the diabetes specific self-efficacy scale. Patients will report their confidence in their abilities to take care of certain diabetes related behaviors. Spouses will report on their confidence of the patient's ability to engage in diabetes self care behaviors. The scale ranges from 0-100.

Trial Locations

Locations (1)

Carnegie Mellon Universityl; 🇺🇸 Pittsburgh, Pennsylvania, United States