- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04014582
Taking Action: a Care for Type 2 Diabetes Intervention for Couples (TACTIC)
Communal Coping Intervention for Couples With Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15206
- Carnegie Mellon Universityl
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Communal Coping Intervention
This group will participate in diabetes education + a communal coping based intervention.
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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.
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Active Comparator: Control
This group will participate in diabetes education and an individual intervention.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in depressive symptoms
Time Frame: Depressive symptoms will be measured at baseline and 1 month after the intervention.
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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.
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Depressive symptoms will be measured at baseline and 1 month after the intervention.
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Change in life satisfaction
Time Frame: Life satisfaction will be measured at baseline and 1 month after the intervention.
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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.
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Life satisfaction will be measured at baseline and 1 month after the intervention.
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Change in perceived stress
Time Frame: Perceived stress will be measured at baseline and 1 month after the intervention.
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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.
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Perceived stress will be measured at baseline and 1 month after the intervention.
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Change in relationship satisfaction--QMI
Time Frame: Relationship satisfaction--QMI will be measured at baseline and 1 month after the intervention.
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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.
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Relationship satisfaction--QMI will be measured at baseline and 1 month after the intervention.
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Change in relationship satisfaction--PAIR
Time Frame: Relationship satisfaction will be measured at baseline and 1 month after the intervention.
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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.
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Relationship satisfaction will be measured at baseline and 1 month after the intervention.
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Change in diabetes self-care
Time Frame: Diabetes self-care will be measured at baseline and 1 month after the intervention.
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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.
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Diabetes self-care will be measured at baseline and 1 month after the intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in perceived emotional responsiveness
Time Frame: Perceived emotional responsiveness will be measured at measured at baseline and 1 month after the intervention.
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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.
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Perceived emotional responsiveness will be measured at measured at baseline and 1 month after the intervention.
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Change in generalized self-efficacy
Time Frame: Self-efficacy will be measured at baseline and 1 month after the intervention.
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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.
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Self-efficacy will be measured at baseline and 1 month after the intervention.
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Change in diabetes specific self-efficacy
Time Frame: Self-efficacy will be measured at baseline and 1 month after the intervention.
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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.
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Self-efficacy will be measured at baseline and 1 month after the intervention.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily mood
Time Frame: Daily mood will be measured over a 7 day daily diary period.
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Daily mood will be assessed via a modified version of the PANAS scale.
These items will be assessed via 1 not at all to 5 a lot.
Negative items will be reversed coded so that greater overall scale scores reflect more positive daily mood.
Both patients and spouses will report on daily mood.
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Daily mood will be measured over a 7 day daily diary period.
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Daily self-care behaviors.
Time Frame: Daily mood will be measured over a 7 day daily diary period.
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Daily mood will be assessed via a modified version of SDSCA scale.
The response scale for these items will vary based on the question.
Higher scores will reflect more daily self-care behaviors.
Patients will report on their own self-care behaviors and spouses will report on the patient's self-care behavior.
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Daily mood will be measured over a 7 day daily diary period.
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Daily relationship satisfaction
Time Frame: Daily relationship satisfaction will be measured over a 7 day daily diary period.
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Daily relationship satisfaction will be assessed via a shortened and modified version of the QMI scale.
Numbers range from 1-7 with higher numbers reflect greater relationship satisfaction.
Both patients and spouses will report on relationship satisfaction.
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Daily relationship satisfaction will be measured over a 7 day daily diary period.
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Daily diabetes self-efficacy
Time Frame: Daily diabetes self efficacy will be measured over a 7 day daily diary period.
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Daily diabetes self-efficacy will be assessed via shortened and modified versions of diabetes self-efficacy scale.
Scale ranges from 0-100 with higher numbers representing more self-efficacy.
Patients will report how confident they felt that day regarding their diabetes management that day.
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Daily diabetes self efficacy will be measured over a 7 day daily diary period.
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Daily self-efficacy
Time Frame: Daily self efficacy will be measured over a 7 day daily diary period.
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Daily self-efficacy will be assessed via shortened and modified versions of the new generalized self-efficacy scale.
Higher numbers will reflect greater self-efficacy.
Both patients and spouses will report on daily generalized self-efficacy.
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Daily self efficacy will be measured over a 7 day daily diary period.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY2019_00000227
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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