Acute IllnessPhase 2NCT00178412
Improving Outcomes of Hospitalized Elders and Caregivers
A Phase 2 study testing Care Project for Hospitalized Elders & Family Caregivers and Comparison Group in people with Acute Illness, run by University of Rochester at 1 site in United States.
Trial summary
In this study, an intervention is tested that is designed to improve the outcomes of hospitalized elders and family caregivers. Study design: randomized, controlled study participants: 280 family caregivers aged 21 or above length of follow-up: 2 weeks and 2 months after hospitalization Study hypothesis: In this… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Illness
- What is being tested?
- Care Project for Hospitalized Elders & Family Caregivers and Comparison Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 421 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Mar 2009
- Phase
- Phase 2
- 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
- age of 21 years or above;
- have an elderly relative (65 years or above) admitted to the three study units within the past 24-48 hours; (c) are related to the patient by blood, marriage, adoption, or affinity as a significant other (e.g., life partner, close friend);
- are primary CGs;
- can read and speak English; and
- live within a 1-hour drive of the facility (60 miles).
Who cannot join
- paid care providers;
- unable to complete the questionnaires or provide care because of their own mental or physical impairment;
- Patient:
- dies during the hospital stay or within 2 months after discharge;
- is transferred from the Intensive Care Unit (ICU) and stayed in the ICU for more than 2 nights;
- is diagnosed with dementia;
Show all 9Show fewer
- is admitted from a long-term care facility; and
- is hospitalized for longer than 30 days
- is staying longer than 6 weeks in a nursing home immediately after hospitalization.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester School of Nursing
Rochester, New York, 14642
About this study
In this study, an intervention is tested that is designed to improve the outcomes of hospitalized elders and family caregivers.
Study design:
Read more
- randomized, controlled study
- participants: 280 family caregivers aged 21 or above
- length of follow-up: 2 weeks and 2 months after hospitalization
Study hypothesis: In this randomized clinical trial, the following hypotheses will be tested:
- Hospitalized elders whose family CGs receive the CARE program versus those who receive a comparison program will have better outcomes during and after hospitalization as measured by: (1) fewer incidents of dysfunctional syndrome; (2) shorter hospital stays; (3) lower readmission rates; (4) less depressive symptoms; (5) higher cognitive level; (6) less functional decline perceived by family CG; and (7) a closer relationship with their family CGs.
- Family CGs of hospitalized elders who receive the CARE program will report: (1) More positive beliefs about their loved one's responses to hospitalization and their role in the hospital setting; (2) more positive emotional outcomes (less worry, anxiety, and depressive symptoms) during and after hospitalization; (3) More participation in their loved one's care during hospitalization; and (4) More positive role outcomes (more role reward, less role strain, more prepared for their loved one's care, and a closer relationship with their elderly relatives, both during and after hospitalization).
- The proposed model to explain the effects of the CARE program on the process and outcomes of family CG coping and elderly patient outcomes will be supported for CGs and elderly patients.
Read the detailed description
More than 12 million elderly people are hospitalized each year in the United Status, frequently resulting in functional decline. Family care of hospitalized elders is important given the increasing numbers of hospitalized elders, needs for elder care in the home after hospital discharge, and responsibilities of family caregivers for providing this care. Involving family caregivers in the hospital care of their loved one may result in positive outcomes for both the elderly patients and their family caregivers. However, there is a paucity of empirical studies that have been conducted to evaluate the effectiveness of interventions to enhance family participation in caring for hospitalized elders. In the proposed study, we will build upon our prior work that has demonstrated the positive effects of theoretically-driven interventions with families of hospitalized patients and older adults at home. Among the unique contributions of this study include: (a) a randomized controlled design, (b) testing of a theoretically-driven, reproducible intervention that can be easily translated into clinical practice and widely disseminated; (c) the testing of an explanatory model to explain the effects of the intervention, (d) a prospective cost-effectiveness analysis; and (e) an intervention that begins early in the hospital stay, and (f) measurement of both short- and more long-term outcomes, up to 2 months following hospital discharge.
The primary aim of this study is to evaluate the effects of a theoretically-driven, reproducible intervention (CARE: Creating Avenues for Relative Empowerment) on the process and outcomes of hospitalized elders and their family caregivers. The secondary aims are to: (a) explore what factors moderate the effects of the intervention program (e.g., social economic status and family preferences for care participation); and (b) determine the cost-effectiveness of the CARE program. A two-group experiment will be used with 280 family caregivers of hospitalized elders. Measures of both process and outcome variables will be included, such as family caregiver beliefs, anxiety, worry, depression, role outcomes, as well as elderly patients outcomes during hospitalization and after hospital discharge. Findings from a recent pilot study with 49 family caregiver-elders dyads support undertaking this full-scale clinical trial in that family caregivers who received the CARE program, versus those who received a comparison program, had more positive coping and role outcomes and their hospitalized elderly relatives had positive outcomes during and after hospitalization.
- Conditions
- Acute Illness
- Being tested
- Care Project for Hospitalized Elders & Family Caregivers, Comparison Group
- Keywords
- Hospitalized elders, Family caregivers, Acute care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Project for Hospitalized Elders & Family CaregiversBehavioural
Phase 1 in-hospital contact: Family caregivers complete baseline data, listen to a tape about helping the elderly relative cope with hospitalization, and work on a mutual agreement/identification of goals for participation in family member's hospital care (i.e., selection of two complications to focus on based on patient's illness condition)
Phase 2 pre-hospital discharge: Family caregivers listen to a second tape about coping with the hospital experience, participating in their family member's in-hospital care, and preparing for hospital discharge/transition to home
Comparison GroupBehavioural
Phase 1 in-hospital contact: Family caregivers complete baseline data and listen to an informational tape about hospital policies.
Phase 2 pre-hospital discharge: Family caregivers listen to a second informational tape about the hospital and medical center.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment group Receives: Behavioral: Care Project for Hospitalized Elders & Family Caregivers |
| 2 | Active comparator | Comparison Group Receives: Behavioral: Comparison Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' outcomes: rates of dysfunctional syndrome, readmission rate, and depression.
Measured: At intake, 1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge
Family Caregiver: emotional coping (worry, anxiety and depression); functional coping (participation in patient's care); and role outcomes(role reward, role strain)
Measured: 1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge
Secondary outcomes (1)
Cost analysis.
Measured: At intake, 1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionApr 2006
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute IllnessStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Bethel Powers, University of Rochester
- Investigators
- Hong Li, Ph.D., RN, Principal investigator, University of Rochester School of NursingBethel A Powers, RN, PhD, Principal investigator, University of Rochester School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178412
- Sponsor's protocol ID
- R01NR008455-01
- Other IDs
- R01NR008455
- Status last verified
- Jun 2012
- First submitted
- 12 Sep 2005
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li H, Melnyk BM, McCann R. Review of intervention studies of families with hospitalized elderly relatives. J Nurs Scholarsh. 2004;36(1):54-9. doi: 10.1111/j.1547-5069.2004.04011.x.
PubMed 15098419Li H, Melnyk BM, McCann R, Chatcheydang J, Koulouglioti C, Nichols LW, Lee MD, Ghassemi A. Creating avenues for relative empowerment (CARE): a pilot test of an intervention to improve outcomes of hospitalized elders and family caregivers. Res Nurs Health. 2003 Aug;26(4):284-99. doi: 10.1002/nur.10091.
PubMed 12884417Li H. Family caregivers' preferences in caring for their hospitalized elderly relatives. Geriatr Nurs. 2002 Jul-Aug;23(4):204-7. doi: 10.1067/mgn.2002.126966.
PubMed 12183745Li H. Hospitalized elders and family caregivers: a typology of family worry. J Clin Nurs. 2005 Jan;14(1):3-8. doi: 10.1111/j.1365-2702.2004.01013.x.
PubMed 15656842Li H. Identifying family care process themes in caring for their hospitalized elders. Appl Nurs Res. 2005 May;18(2):97-101. doi: 10.1016/j.apnr.2004.06.015.
PubMed 15991107
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes of Hospitalized Elders and Caregivers
- ClinicalTrials.gov ID
- NCT00178412
- Acronym / sponsor ID
- R01NR008455-01
- Conditions
- Acute Illness
- Keywords
- Hospitalized elders, Family caregivers, Acute care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Apr 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 15 Sep 2005 (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.
In this study, an intervention is tested that is designed to improve the outcomes of hospitalized elders and family caregivers.
Study design:
- randomized, controlled study
- participants: 280 family caregivers aged 21 or above
- length of follow-up: 2 weeks and 2 months after hospitalization
Study hypothesis: In this randomized clinical trial, the following hypotheses will be tested:
- Hospitalized elders whose family CGs receive the CARE program versus those who receive a comparison program will have better outcomes during and after hospitalization as measured by: (1) fewer incidents of dysfunctional syndrome; (2) shorter hospital stays; (3) lower readmission rates; (4) less depressive symptoms; (5) higher cognitive level; (6) less functional decline perceived by family CG; and (7) a closer relationship with their family CGs.
- Family CGs of hospitalized elders who receive the CARE program will report: (1) More positive beliefs about their loved one's responses to hospitalization and their role in the hospital setting; (2) more positive emotional outcomes (less worry, anxiety, and depressive symptoms) during and after hospitalization; (3) More participation in their loved one's care during hospitalization; and (4) More positive role outcomes (more role reward, less role strain, more prepared for their loved one's care, and a closer relationship with their elderly relatives, both during and after hospitalization).
- The proposed model to explain the effects of the CARE program on the process and outcomes of family CG coping and elderly patient outcomes will be supported for CGs and elderly patients.
Detailed description
More than 12 million elderly people are hospitalized each year in the United Status, frequently resulting in functional decline. Family care of hospitalized elders is important given the increasing numbers of hospitalized elders, needs for elder care in the home after hospital discharge, and responsibilities of family caregivers for providing this care. Involving family caregivers in the hospital care of their loved one may result in positive outcomes for both the elderly patients and their family caregivers. However, there is a paucity of empirical studies that have been conducted to evaluate the effectiveness of interventions to enhance family participation in caring for hospitalized elders. In the proposed study, we will build upon our prior work that has demonstrated the positive effects of theoretically-driven interventions with families of hospitalized patients and older adults at home. Among the unique contributions of this study include: (a) a randomized controlled design, (b) testing of a theoretically-driven, reproducible intervention that can be easily translated into clinical practice and widely disseminated; (c) the testing of an explanatory model to explain the effects of the intervention, (d) a prospective cost-effectiveness analysis; and (e) an intervention that begins early in the hospital stay, and (f) measurement of both short- and more long-term outcomes, up to 2 months following hospital discharge.
The primary aim of this study is to evaluate the effects of a theoretically-driven, reproducible intervention (CARE: Creating Avenues for Relative Empowerment) on the process and outcomes of hospitalized elders and their family caregivers. The secondary aims are to: (a) explore what factors moderate the effects of the intervention program (e.g., social economic status and family preferences for care participation); and (b) determine the cost-effectiveness of the CARE program. A two-group experiment will be used with 280 family caregivers of hospitalized elders. Measures of both process and outcome variables will be included, such as family caregiver beliefs, anxiety, worry, depression, role outcomes, as well as elderly patients outcomes during hospitalization and after hospital discharge. Findings from a recent pilot study with 49 family caregiver-elders dyads support undertaking this full-scale clinical trial in that family caregivers who received the CARE program, versus those who received a comparison program, had more positive coping and role outcomes and their hospitalized elderly relatives had positive outcomes during and after hospitalization.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Care Project for Hospitalized Elders & Family CaregiversTreatment group |
| 2 | Active comparator | Behavioral: Comparison GroupComparison Group |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age of 21 years or above;
- have an elderly relative (65 years or above) admitted to the three study units within the past 24-48 hours; (c) are related to the patient by blood, marriage, adoption, or affinity as a significant other (e.g., life partner, close friend);
- are primary CGs;
- can read and speak English; and
- live within a 1-hour drive of the facility (60 miles).
Key exclusion criteria (9 listed)
- paid care providers;
- unable to complete the questionnaires or provide care because of their own mental or physical impairment;
- dies during the hospital stay or within 2 months after discharge;
- is transferred from the Intensive Care Unit (ICU) and stayed in the ICU for more than 2 nights;
- is diagnosed with dementia;
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 |
|---|---|---|
| Care Project for Hospitalized Elders & Family CaregiversPhase 1 in-hospital contact: Family caregivers complete baseline data, listen to a tape about helping the elderly relative cope with hospitalization, and work on a mutual agreement/identification of goals for participation in family member's hospital care (i.e., selection of two complications to focus on based on patient's illness condition) Phase 2 pre-hospital discharge: Family caregivers listen to a second tape about coping with the hospital experience, participating in their family member's in-hospital care, and preparing for hospital discharge/transition to home | Behavioural | 1 |
| Comparison GroupPhase 1 in-hospital contact: Family caregivers complete baseline data and listen to an informational tape about hospital policies. Phase 2 pre-hospital discharge: Family caregivers listen to a second informational tape about the hospital and medical center. | Behavioural | 2 |
Primary outcome
Patients' outcomes: rates of dysfunctional syndrome, readmission rate, and depression.
Time frame: At intake, 1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge
Family Caregiver: emotional coping (worry, anxiety and depression); functional coping (participation in patient's care); and role outcomes(role reward, role strain)
Time frame: 1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge
1 secondary outcome
Cost analysis.
Time frame: At intake, 1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge
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 14 Jun 2012.
- Background: PubMed 15098419Li H, Melnyk BM, McCann R. Review of intervention studies of families with hospitalized elderly relatives. J Nurs Scholarsh. 2004;36(1):54-9. doi: 10.1111/j.1547-5069.2004.04011.x.
- Background: PubMed 12884417Li H, Melnyk BM, McCann R, Chatcheydang J, Koulouglioti C, Nichols LW, Lee MD, Ghassemi A. Creating avenues for relative empowerment (CARE): a pilot test of an intervention to improve outcomes of hospitalized elders and family caregivers. Res Nurs Health. 2003 Aug;26(4):284-99. doi: 10.1002/nur.10091.
- Background: PubMed 12183745Li H. Family caregivers' preferences in caring for their hospitalized elderly relatives. Geriatr Nurs. 2002 Jul-Aug;23(4):204-7. doi: 10.1067/mgn.2002.126966.
- Results publication: PubMed 15656842Li H. Hospitalized elders and family caregivers: a typology of family worry. J Clin Nurs. 2005 Jan;14(1):3-8. doi: 10.1111/j.1365-2702.2004.01013.x.
- Results publication: PubMed 15991107Li H. Identifying family care process themes in caring for their hospitalized elders. Appl Nurs Res. 2005 May;18(2):97-101. doi: 10.1016/j.apnr.2004.06.015.
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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.
Hong Li, Ph.D., RN principal investigator
University of Rochester School of Nursing
Bethel A Powers, RN, PhD principal investigator
University of Rochester School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Care Project for Hospitalized Elders & Family Caregivers and Comparison Group in people with Acute Illness, run by University of Rochester 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 9 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 14 Jun 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patients' outcomes: rates of dysfunctional syndrome, readmission rate, and depression. (time frame: At intake, 1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge). The study lists 2 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 NCT00178412, which also lists 5 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 14 Jun 2012.