Health PromotionNCT01188070
Caregiver Stress: Interventions to Promote Health and Wellbeing
A study testing Psycho-education and Psycho-education plus physical exercise in people with Health Promotion, run by Emory University at 1 site in United States.
Trial summary
More and more family members are providing care to their loved ones with prolonged and progressive illnesses. Chronic intense caregiving represents a situation of chronic stress, which takes a toll on one's mental and physical health including an increased risk for the development or worsening of heart disease. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Promotion
- What is being tested?
- Psycho-education and Psycho-education plus physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 354 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2014
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Family caregiver defined as a spouse, partner or other adult family member living in the same house or in contact with a HF patient or dementia patient in a caregiver relationship at least 4 times/week for at least one hour or more.
- willing to participate
- English fluency
- ambulatory and physically able to engage in a structured low impact walking and upper body strength training program.
- self identify as African American for the Alzheimer FCG study
Who cannot join
- non sedentary (defined as engaging in > 30 minutes of moderately strenuous exercise 3 times or more a week)
- medical or physical condition that would preclude participation in the exercise component of the study (e.g., severe arthritis or mobility problems, uncontrolled hypertension or diabetes, renal insufficiency, or a history of angina with activity)
- current psychiatric comorbidity (alcohol or drug abuse/dependence, bipolar or psychotic disorder, suicidal ideation detected on the MINI screening tool)
- current smoker
- cognitive problems (BLESSED screen)
- ischemic changes or inappropriate BP changes on BL exercise (modified Balke) treadmill test
- on corticosteroids
- experiencing an acute inflammation at time of baseline or follow-up testing (this will result in rescheduling of testing if no other exclusion criteria apply)
Trial locations and contacts
1 site in 1 country.
About this study
More and more family members are providing care to their loved ones with prolonged and progressive illnesses. Chronic intense caregiving represents a situation of chronic stress, which takes a toll on one's mental and physical health including an increased risk for the development or worsening of heart disease. Identification of effective self-care interventions for family caregivers is warranted to improve their emotional wellbeing and minimize the harmful effects of chronic stress on the heart. This Program Project Grant aims to promote health and reduce cardiovascular risk in family caregivers (FCG) of persons with chronic illness. In two studies the investigators will test two interventions, psycho-education(ED) and physical exercise(EX), individually and in combination. The first study will target FCG of African American dementia patients; the second will focus on FCG of heart failure patients. Parallel designs, interventions and measures will create synergy as will integration of all data management and analyses within a Bio-behavioral Science and Measures Core. This Core will also provide high level guidance and interpretation of model testing resulting from analysis of the common data set. The combined de-identified data set will allow for elucidating the biological mechanisms of stress-induced cardiovascular risk, further developing the model, and stimulating future research, while the shared core support will provide substantial efficiency; neither could be achieved outside of a Program Project approach. These collective efforts will generate important data whereby future care can significantly enhance the lives of FCG and minimize their risk of cardiovascular disease, the number one cause of disability and death in the United States.
We hypothesize that FCGs who receive the combined PSYCHED+EX intervention will have better psychological functioning (lower levels of depressive symptoms, anxiety, and caregiver burden and higher levels of flourishing), behavioral outcomes (improved sleep quality and greater physical function), cardiovascular risk measures (improved resting heart rate, blood pressure, heart rate recovery, oxygen consumption, lipids, glucose, and inflammatory markers), neuroendocrine function (salivary cortisol) and overall health outcomes (improved function, muscle strength, and endurance) compared to psycho-education and usual care-attention control from baseline to six months later mediated by improvements in process outcomes (lower perceived stress and higher self-efficacy).
- Conditions
- Health Promotion
- Being tested
- Usual Care, Psycho-education, Psycho-education plus physical exercise
- Keywords
- Behavioral/Social, Cardiology, Clinical Laboratory Methods, Congestive Heart Failure, Heart Disease, Knowledge Dissemination, Lipids, Nursing, Health Promotion, Alzheimer's Disease/Dementia
- Medical subject headings
- Behavior, Heart Failure, Heart Diseases, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
Educational materials
Psycho-educationBehavioural
Educational group sessions
Psycho-education plus physical exerciseBehavioural
Psychoeducation intervention plus an individualized exercise program
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Attention Control | Sham comparator | Provision of printed educational material and attendance at one group session. This session will focus on nutrition education and flexibility and stretching. Receives: Behavioral: Usual Care |
| Psychoeducation plus exercise | Experimental | Psychoeducation intervention plus an individualized exercise program which will include monitored, individually-prescribed aerobic and resistance exercise. Receives: Behavioral: Psycho-education plus physical exercise |
| Psychoeducation | Active comparator | Psychoeducational program to involve group sessions over consecutive weeks. The sessions will use the principles of adult learning, emphasizing active learning, group exercises and discussion, and coaching as well as brief talks to provide content. The curriculum will focus on the strengthening of caregiver self-efficacy through enhancement of knowledge and understanding, the acquisition, strengthening, and practice of caregiving skills, and the development of a more clinical or strategic outlook on the caregiving role. Receives: Behavioral: Psycho-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional outcomes
Depression, Anxiety, Caregiver Burden, Flourishing
Measured: Baseline and 6 months
Behavioral Outcomes
Physical Activity, Sleep Quality
Measured: Baseline and 6 months
Health Status
Function, Muscle strength, endurance
Measured: Baseline and 6 months
Neuroendocrine
Salivary Cortisol
Measured: Frame Baseline and 6 months
Cardiovascular Risk Outcomes
Biochemical Markers (Inflammation Coagulation Insulin Resistance) Cardiovascular Reactivity \& Risk
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health PromotionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, ECorwin, Emory University
- Investigators
- Andrew Miller, MD, Principal investigator, Emory UniversityKenneth Hepburn, PhD, Study chair, Emory UniversitySandra Dunbar, DSN, Study chair, Emory UniversityMonica Parker, MD, Study chair, Emory UniversityElizabeth J Corwin, PhD, Principal investigator, Emory University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188070
- Sponsor's protocol ID
- IRB00032005
- Other IDs
- P01NR011587
- Status last verified
- Feb 2017
- First submitted
- 14 Jun 2010
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Corrigendum. J Appl Gerontol. 2020 Feb;39(2):NP1. doi: 10.1177/0733464818775576. Epub 2018 Apr 30.
PubMed 29708007Gary R, Dunbar SB, Higgins M, Butts B, Corwin E, Hepburn K, Butler J, Miller AH. An Intervention to Improve Physical Function and Caregiver Perceptions in Family Caregivers of Persons With Heart Failure. J Appl Gerontol. 2020 Feb;39(2):181-191. doi: 10.1177/0733464817746757. Epub 2018 Jan 18.
PubMed 29347863
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Stress: Interventions to Promote Health and Wellbeing
- ClinicalTrials.gov ID
- NCT01188070
- Acronym / sponsor ID
- IRB00032005
- Conditions
- Health Promotion
- Keywords
- Behavioral/Social, Cardiology, Clinical Laboratory Methods, Congestive Heart Failure, Heart Disease, Knowledge Dissemination, Lipids, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jan 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 25 Aug 2010 (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.
More and more family members are providing care to their loved ones with prolonged and progressive illnesses. Chronic intense caregiving represents a situation of chronic stress, which takes a toll on one's mental and physical health including an increased risk for the development or worsening of heart disease. Identification of effective self-care interventions for family caregivers is warranted to improve their emotional wellbeing and minimize the harmful effects of chronic stress on the heart. This Program Project Grant aims to promote health and reduce cardiovascular risk in family caregivers (FCG) of persons with chronic illness. In two studies the investigators will test two interventions, psycho-education(ED) and physical exercise(EX), individually and in combination. The first study will target FCG of African American dementia patients; the second will focus on FCG of heart failure patients. Parallel designs, interventions and measures will create synergy as will integration of all data management and analyses within a Bio-behavioral Science and Measures Core. This Core will also provide high level guidance and interpretation of model testing resulting from analysis of the common data set. The combined de-identified data set will allow for elucidating the biological mechanisms of stress-induced cardiovascular risk, further developing the model, and stimulating future research, while the shared core support will provide substantial efficiency; neither could be achieved outside of a Program Project approach. These collective efforts will generate important data whereby future care can significantly enhance the lives of FCG and minimize their risk of cardiovascular disease, the number one cause of disability and death in the United States.
We hypothesize that FCGs who receive the combined PSYCHED+EX intervention will have better psychological functioning (lower levels of depressive symptoms, anxiety, and caregiver burden and higher levels of flourishing), behavioral outcomes (improved sleep quality and greater physical function), cardiovascular risk measures (improved resting heart rate, blood pressure, heart rate recovery, oxygen consumption, lipids, glucose, and inflammatory markers), neuroendocrine function (salivary cortisol) and overall health outcomes (improved function, muscle strength, and endurance) compared to psycho-education and usual care-attention control from baseline to six months later mediated by improvements in process outcomes (lower perceived stress and higher self-efficacy).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care Attention Control | Sham comparator | Behavioral: Usual CareProvision of printed educational material and attendance at one group session. This session will focus on nutrition education and flexibility and stretching. |
| Psychoeducation plus exercise | Experimental | Behavioral: Psycho-education plus physical exercisePsychoeducation intervention plus an individualized exercise program which will include monitored, individually-prescribed aerobic and resistance exercise. |
| Psychoeducation | Active comparator | Behavioral: Psycho-educationPsychoeducational program to involve group sessions over consecutive weeks. The sessions will use the principles of adult learning, emphasizing active learning, group exercises and discussion, and coaching as well as brief talks to provide content. The curriculum will focus on the strengthening of caregiver self-efficacy through enhancement of knowledge and understanding, the acquisition, strengthening, and practice of caregiving skills, and the development of a more clinical or strategic outlook on the caregiving role. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Family caregiver defined as a spouse, partner or other adult family member living in the same house or in contact with a HF patient or dementia patient in a caregiver relationship at least 4 times/week for at least one hour or more.
- willing to participate
- English fluency
- ambulatory and physically able to engage in a structured low impact walking and upper body strength training program.
- self identify as African American for the Alzheimer FCG study
Key exclusion criteria (8 listed)
- non sedentary (defined as engaging in > 30 minutes of moderately strenuous exercise 3 times or more a week)
- medical or physical condition that would preclude participation in the exercise component of the study (e.g., severe arthritis or mobility problems, uncontrolled hypertension or diabetes, renal insufficiency, or a history of angina with activity)
- current psychiatric comorbidity (alcohol or drug abuse/dependence, bipolar or psychotic disorder, suicidal ideation detected on the MINI screening tool)
- current smoker
- cognitive problems (BLESSED screen)
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 |
|---|---|---|
| Usual CareEducational materials | Behavioural | Usual Care Attention Control |
| Psycho-educationEducational group sessions | Behavioural | Psychoeducation |
| Psycho-education plus physical exercisePsychoeducation intervention plus an individualized exercise program | Behavioural | Psychoeducation plus exercise |
Primary outcome
Emotional outcomes
Time frame: Baseline and 6 months
Depression, Anxiety, Caregiver Burden, Flourishing
Behavioral Outcomes
Time frame: Baseline and 6 months
Physical Activity, Sleep Quality
Health Status
Time frame: Baseline and 6 months
Function, Muscle strength, endurance
Neuroendocrine
Time frame: Frame Baseline and 6 months
Salivary Cortisol
Cardiovascular Risk Outcomes
Time frame: Baseline and 6 months
Biochemical Markers (Inflammation Coagulation Insulin Resistance) Cardiovascular Reactivity \& Risk
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 23 Feb 2017.
- Derived from this study: PubMed 29708007Corrigendum. J Appl Gerontol. 2020 Feb;39(2):NP1. doi: 10.1177/0733464818775576. Epub 2018 Apr 30.
- Derived from this study: PubMed 29347863Gary R, Dunbar SB, Higgins M, Butts B, Corwin E, Hepburn K, Butler J, Miller AH. An Intervention to Improve Physical Function and Caregiver Perceptions in Family Caregivers of Persons With Heart Failure. J Appl Gerontol. 2020 Feb;39(2):181-191. doi: 10.1177/0733464817746757. Epub 2018 Jan 18.
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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.
Andrew Miller, MD principal investigator
Emory University
Kenneth Hepburn, PhD study chair
Emory University
Sandra Dunbar, DSN study chair
Emory 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 Psycho-education and Psycho-education plus physical exercise in people with Health Promotion, run by Emory University at 1 site in United States.
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 8 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 23 Feb 2017. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Emotional outcomes (time frame: Baseline and 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01188070, which also lists 2 linked publications.
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 23 Feb 2017.