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

NCT04014582 | Completed

• 1 other identifier: STUDY2019_00000227
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

communal coping; couples coping; adjustment

Outcome Measures

Primary Outcomes (6)

• Change in depressive symptoms

  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.

  Depressive symptoms will be measured at baseline and 1 month after the intervention.

• Change in life satisfaction

  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.

  Life satisfaction will be measured at baseline and 1 month after the intervention.

• Change in perceived stress

  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.

  Perceived stress will be measured at baseline and 1 month after the intervention.

• Change in relationship satisfaction--QMI

  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.

  Relationship satisfaction--QMI will be measured at baseline and 1 month after the intervention.

• Change in relationship satisfaction--PAIR

  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.

  Relationship satisfaction will be measured at baseline and 1 month after the intervention.

• Change in diabetes self-care

  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.

  Diabetes self-care will be measured at baseline and 1 month after the intervention.

Secondary Outcomes (3)

• Change in perceived emotional responsiveness

  Perceived emotional responsiveness will be measured at measured at baseline and 1 month after the intervention.

• Change in generalized self-efficacy

  Self-efficacy will be measured at baseline and 1 month after the intervention.

• Change in diabetes specific self-efficacy

  Self-efficacy will be measured at baseline and 1 month after the intervention.

Other Outcomes (5)

• Daily mood

  Daily mood will be measured over a 7 day daily diary period.

• Daily self-care behaviors.

  Daily mood will be measured over a 7 day daily diary period.

• Daily relationship satisfaction

  Daily relationship satisfaction will be measured over a 7 day daily diary period.

Study Arms (2)

Communal Coping Intervention

EXPERIMENTAL

This group will participate in diabetes education + a communal coping based intervention.

Behavioral: Communal Coping Intervention

Control

ACTIVE COMPARATOR

This group will participate in diabetes education and an individual intervention.

Behavioral: Diabetes Education

Interventions

Communal Coping Intervention BEHAVIORAL

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. 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. These couples will also receive a brief diabetes education.

Communal Coping Intervention

Diabetes Education BEHAVIORAL

Couples in the diabetes education group will receive a brief diabetes education and complete individual implementation intentions. Patients will create implementation intentions related to diabetes and partners will create implementation intentions that are not related to health.

Also known as: Control

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Carnegie Mellon University: lead

Study Sites (1)

Carnegie Mellon Universityl

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to condition, and they will not be aware if they are in the intervention or control group. The control group is more than usual care, so they may also believe they are in the intervention group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate Psychology

Model Details: Participants will be assigned to one of two groups, either the intervention or the control (diabetes education) condition

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 10, 2019
• Study Start: July 20, 2019
• Primary Completion: April 14, 2020
• Study Completion: April 14, 2020
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The above data and materials will be made available upon first publication from the study.
• Access Criteria: The data will openly accessible and discoverable with a unique DOI on CMU's Kilthub data sharing platform.

Locations

US (1)