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Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial (ACHD-CARE)

Primary Purpose

Heart Defects, Congenital

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ACHD-CARE Program
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Defects, Congenital focused on measuring Quality of life, Psychosocial Support Systems, Randomized Controls as Topic, Cognitive Therapy, Feasibility Studies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented congenital heart disease (CHD), as confirmed by echocardiogram, cardiac catheterization, or previous surgery
  • Age greater than or equal to 18 years
  • English-language proficiency sufficient to read and complete the consent form and questionnaires and participate in an English-language group
  • No planned surgery during patient's participation in the study
  • Clinically-elevated score (i.e >=8) on the Hospital Anxiety and Depression Scale depression (HADS-D) or anxiety (HADS-A) subscale

Exclusion Criteria:

  • Current psychotherapy or pharmacotherapy
  • Significant cognitive impairment, psychosis, or personality disorder as documented in medical chart
  • Report of suicidal intent during screening

Sites / Locations

  • Toronto Congenital Cardiac Clinic for Adults, Peter Munk Cardiac Centre, Toronto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

ACHD-CARE Program

Arm Description

Patients in this arm of the study will continue to receive their regular level of care.

Group based psychosocial intervention. Educational: congenital heart disease information Behavioral: cognitive behavioral therapy Behavioral: social interactions and communication skills

Outcomes

Primary Outcome Measures

Psychosocial Outcome Measures: Change in depression and anxiety symptoms
Symptoms of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)

Secondary Outcome Measures

Psychological Outcome Measures: Social functioning
Two metrics will be used to assess social functioning; the Social Functioning subscale of the Short Form Health Status Survey (SF-12v2) and the Enhanced Recovery in Coronary Heart Disease (ENRICHD) Social Support Inventory (ESSI).
Psychosocial Outcome Measures: Resilience
This psychosocial outcome will be measured by the Resilience Scale (RS).
Psychosocial Outcome Measures: Quality of Life and health status
The quality of life of the participants will be measured using the Satisfaction with Life Scales (SWLS) and the Linear Analogue Scale (LAS). Health status will be assessed using the SF-12v2.

Full Information

First Posted
May 31, 2013
Last Updated
December 23, 2015
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01881893
Brief Title
Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial
Acronym
ACHD-CARE
Official Title
Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The psychosocial development of adults with congenital heart disease (CHD) can be challenged by many issues including family overprotection, impaired peer relationships, delayed progression into independent adulthood, and difficulties with career and future planning. One-third of patients have diagnosable mood or anxiety disorders and the prevalence of depression is 3 times that of the general Canadian population. Unfortunately, most adults with CHD and significant depression or anxiety do not receive mental health treatment. Despite an increasing awareness of the unique psychosocial concerns of this patient population by both health care providers and patients, there have been no interventions targeting psychosocial outcomes in the adult CHD population. Our quantitative and qualitative research suggests that patients themselves are very interested in psychological services that target their distinctive life experiences, are provided in a group setting, and emphasize coping and resilience. The overarching aim of this proposal is to assess the feasibility of a full-scale randomized controlled trial of a group intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital
Keywords
Quality of life, Psychosocial Support Systems, Randomized Controls as Topic, Cognitive Therapy, Feasibility Studies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients in this arm of the study will continue to receive their regular level of care.
Arm Title
ACHD-CARE Program
Arm Type
Experimental
Arm Description
Group based psychosocial intervention. Educational: congenital heart disease information Behavioral: cognitive behavioral therapy Behavioral: social interactions and communication skills
Intervention Type
Behavioral
Intervention Name(s)
ACHD-CARE Program
Intervention Description
The ACHD-CARE program will be provided in eight 90-minute weekly sessions. The intervention includes information about living with congenital heart disease, cognitive behavioral therapy (CBT) and coping techniques, and opportunities for peer interaction.
Primary Outcome Measure Information:
Title
Psychosocial Outcome Measures: Change in depression and anxiety symptoms
Description
Symptoms of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)
Time Frame
Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up
Secondary Outcome Measure Information:
Title
Psychological Outcome Measures: Social functioning
Description
Two metrics will be used to assess social functioning; the Social Functioning subscale of the Short Form Health Status Survey (SF-12v2) and the Enhanced Recovery in Coronary Heart Disease (ENRICHD) Social Support Inventory (ESSI).
Time Frame
Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up
Title
Psychosocial Outcome Measures: Resilience
Description
This psychosocial outcome will be measured by the Resilience Scale (RS).
Time Frame
Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up
Title
Psychosocial Outcome Measures: Quality of Life and health status
Description
The quality of life of the participants will be measured using the Satisfaction with Life Scales (SWLS) and the Linear Analogue Scale (LAS). Health status will be assessed using the SF-12v2.
Time Frame
Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented congenital heart disease (CHD), as confirmed by echocardiogram, cardiac catheterization, or previous surgery Age greater than or equal to 18 years English-language proficiency sufficient to read and complete the consent form and questionnaires and participate in an English-language group No planned surgery during patient's participation in the study Clinically-elevated score (i.e >=8) on the Hospital Anxiety and Depression Scale depression (HADS-D) or anxiety (HADS-A) subscale Exclusion Criteria: Current psychotherapy or pharmacotherapy Significant cognitive impairment, psychosis, or personality disorder as documented in medical chart Report of suicidal intent during screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrienne H Kovacs, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jane Irvine, PhD
Organizational Affiliation
University Health Network, York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Congenital Cardiac Clinic for Adults, Peter Munk Cardiac Centre, Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial

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