Heart Defects, CongenitalACHD-CARENCT01881893
Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial
A study testing ACHD-CARE Program in people with Heart Defects, Congenital, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- ACHD-CARE Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current psychotherapy or pharmacotherapy
- Significant cognitive impairment, psychosis, or personality disorder as documented in medical chart
- Report of suicidal intent during screening
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Congenital Cardiac Clinic for Adults, Peter Munk Cardiac Centre, Toronto General Hospital
Toronto, Ontario, M5G 2N2
About this study
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.
- Conditions
- Heart Defects, Congenital
- Being tested
- ACHD-CARE Program
- Keywords
- Quality of life, Psychosocial Support Systems, Randomized Controls as Topic, Cognitive Therapy, Feasibility Studies
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACHD-CARE ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients in this arm of the study will continue to receive their regular level of care. |
| ACHD-CARE Program | Experimental | Group based psychosocial intervention.
* Educational: congenital heart disease information
* Behavioral: cognitive behavioral therapy
* Behavioral: social interactions and communication skills Receives: Behavioral: ACHD-CARE Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up
Secondary outcomes (3)
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).
Measured: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up
Psychosocial Outcome Measures: Resilience
This psychosocial outcome will be measured by the Resilience Scale (RS).
Measured: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up
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.
Measured: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrienne H Kovacs, PhD, Principal investigator, University Health Network, TorontoJane Irvine, PhD, Principal investigator, University Health Network, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881893
- Sponsor's protocol ID
- MOP 123251
- Acronym
- ACHD-CARE
- Status last verified
- Dec 2015
- First submitted
- 31 May 2013
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial
- ClinicalTrials.gov ID
- NCT01881893
- Acronym / sponsor ID
- ACHD-CARE / MOP 123251
- Conditions
- Heart Defects, Congenital
- Keywords
- Quality of life, Psychosocial Support Systems, Randomized Controls as Topic, Cognitive Therapy, Feasibility Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients in this arm of the study will continue to receive their regular level of care. |
| ACHD-CARE Program | Experimental | Behavioral: ACHD-CARE ProgramGroup based psychosocial intervention. * Educational: congenital heart disease information * Behavioral: cognitive behavioral therapy * Behavioral: social interactions and communication skills |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Current psychotherapy or pharmacotherapy
- Significant cognitive impairment, psychosis, or personality disorder as documented in medical chart
- Report of suicidal intent during screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACHD-CARE ProgramThe 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. | Behavioural | ACHD-CARE Program |
Primary outcome
Psychosocial Outcome Measures: Change in depression and anxiety symptoms
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
Symptoms of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)
3 secondary outcomes
Psychological Outcome Measures: Social functioning
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
Psychosocial Outcome Measures: Resilience
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
Psychosocial Outcome Measures: Quality of Life and health status
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrienne H Kovacs, PhD principal investigator
University Health Network, Toronto
Jane Irvine, PhD principal investigator
University Health Network, York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACHD-CARE Program in people with Heart Defects, Congenital, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial Outcome Measures: Change in depression and anxiety symptoms (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.