Hospice Informal CaregiversNCT01444027

Hospice Problem Solving Intervention

A study testing Problem Solving Therapy in people with Hospice Informal Caregivers, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hospice Informal Caregivers
What is being tested?: Problem Solving Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 514 participants
Where: 1 siteUnited States
Study dates: Oct 2011to Mar 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

enrolled as a family/informal caregiver of a hospice patient
18 years or older
with access to a standard phone line or Internet and computer access at home
without functional hearing loss or with a hearing aid that allows the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver)
no or only mild cognitive impairment
speak and read English, with at least a 6th-grade education

Who cannot join

lack of phone or Internet access

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington
Seattle, Washington, 98195

Other trials in United States

About this study

Official title: A Problem Solving Intervention for Hospice Caregivers

In recent years, the demand for home hospice care has grown rapidly. Family members and friends who act as informal caregivers are essential to the provision of palliative care services; however, this role is not without adverse effects on the caregivers themselves. It is well documented that emotional needs of individuals caring for dying persons in their home are not well attended, and interventions aiming to provide support to informal hospice caregivers are notably lacking. In this context, problem solving therapy (PST) provides an overall coping process that fosters adaptive situational coping and behavioral competence. The investigators are conducting a randomized controlled trial to fully evaluate the PST intervention for informal hospice caregivers. Additionally, the investigators aim to evaluate how the modality of the intervention (face to face vs video) impacts its effectiveness. This investigator team is conducting a 4-year randomized trial study in which hospice caregivers will be randomly assigned to a group receiving standard hospice care with the addition of social support interactions (attention control group) or a group receiving standard hospice care with the addition of the problem solving intervention delivered face to face (intervention group 1) or a group receiving standard hospice care with the addition of the problem solving intervention delivered via video (intervention group 2). The specific aims include an assessment of the impact of PST on caregiver quality of life, problem solving ability, and caregiver anxiety.

Conditions: Hospice Informal Caregivers
Being tested: Problem Solving Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Problem Solving TherapyBehavioural
Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.

Study groups in NCT01444027
Study group	Role	What they receive
Attention Control	No intervention	This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
Intervention Group 1 (Face to Face)	Experimental	This group receives Problem Solving Therapy in face to face visits. Receives: Behavioral: Problem Solving Therapy
Intervention Group 2 (Video)	Experimental	This group receives Problem Solving Therapy via video. Receives: Behavioral: Problem Solving Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Caregiver Anxiety: Change From Baseline to Post-Intervention Exit
Caregiver anxiety was measured with the 7-item Generalized Anxiety Disorder (GAD-7) Scale (Spitzer et al., 2006), which measures the frequency with which respondents experience symptoms of anxiety such as restlessness, difficulty relaxing, and uncontrollable worrying. The GAD-7 total scores range from 0 to 21, with higher scores indicating more anxiety.
Measured: At Baseline and Exit (approximately 4 weeks after recruitment)
Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better physical quality of life.
Measured: At Baseline and Exit (approximately 4 weeks after recruitment)
Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better social quality of life.
Measured: At Baseline and Exit (approximately 4 weeks after recruitment)
Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better emotional quality of life.
Measured: At Baseline and Exit (approximately 4 weeks after recruitment)
Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better financial quality of life.
Measured: At Baseline and Exit (approximately 4 weeks after recruitment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Mar 2016

First posted30 Sep 2011 (estimated)
Study startOct 2011
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Hospice Informal CaregiversStudies of the same condition, open and under way.
More trials run by University of WashingtonThe 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: 514 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01444027
Sponsor's protocol ID: 36909
Other IDs: 1R01NR012213-01A1
Status last verified: Nov 2017
First submitted: 28 Sep 2011
Last updated: 13 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Starr LT, Bullock K, Washington K, Aryal S, Parker Oliver D, Demiris G. Anxiety, Depression, Quality of Life, Caregiver Burden, and Perceptions of Caregiver-Centered Communication among Black and White Hospice Family Caregivers. J Palliat Med. 2022 Apr;25(4):596-605. doi: 10.1089/jpm.2021.0302. Epub 2021 Nov 18.
PubMed 34793244
Demiris G, Oliver DP, Washington K, Pike K. A Problem-Solving Intervention for Hospice Family Caregivers: A Randomized Clinical Trial. J Am Geriatr Soc. 2019 Jul;67(7):1345-1352. doi: 10.1111/jgs.15894. Epub 2019 Apr 4.
PubMed 30946495
Benson JJ, Parker Oliver D, Demiris G, Washington K. Accounts of Family Conflict in Home Hospice Care: The Central Role of Autonomy for Informal Caregiver Resilience. J Fam Nurs. 2019 May;25(2):190-218. doi: 10.1177/1074840719828091. Epub 2019 Feb 17.
PubMed 30773970
Tarter R, Demiris G, Pike K, Washington K, Parker Oliver D. Pain in Hospice Patients With Dementia: The Informal Caregiver Experience. Am J Alzheimers Dis Other Demen. 2016 Sep;31(6):524-9. doi: 10.1177/1533317516653825. Epub 2016 Jun 14.
PubMed 27303062
Oliver DP, Demiris G, Washington KT, Clark C, Thomas-Jones D. Challenges and Strategies for Hospice Caregivers: A Qualitative Analysis. Gerontologist. 2017 Aug 1;57(4):648-656. doi: 10.1093/geront/gnw054.
PubMed 27048707
Washington KT, Pike KC, Demiris G, Parker Oliver D, Albright DL, Lewis AM. Gender Differences in Caregiving at End of Life: Implications for Hospice Teams. J Palliat Med. 2015 Dec;18(12):1048-53. doi: 10.1089/jpm.2015.0214. Epub 2015 Oct 20.
PubMed 26484426
Washington KT, Pike KC, Demiris G, Oliver DP. Unique characteristics of informal hospice cancer caregiving. Support Care Cancer. 2015 Jul;23(7):2121-8. doi: 10.1007/s00520-014-2570-z. Epub 2014 Dec 30.
PubMed 25547480
Washington KT, Wittenberg-Lyles E, Oliver DP, Baldwin PK, Tappana J, Wright JH, Demiris G. Rethinking family caregiving: tailoring cognitive-behavioral therapies to the hospice experience. Health Soc Work. 2014 Nov;39(4):244-50. doi: 10.1093/hsw/hlu031.
PubMed 25369725
Washington KT, Demiris G, Pike KC, Kruse RL, Oliver DP. Anxiety among informal hospice caregivers: an exploratory study. Palliat Support Care. 2015 Jun;13(3):567-73. doi: 10.1017/S1478951513001193. Epub 2014 Feb 13.
PubMed 24524662
Demiris G, Parker Oliver D, Capurro D, Wittenberg-Lyles E. Implementation science: implications for intervention research in hospice and palliative care. Gerontologist. 2014 Apr;54(2):163-71. doi: 10.1093/geront/gnt022. Epub 2013 Apr 4.
PubMed 23558847

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Problem Solving Intervention for Hospice Caregivers
ClinicalTrials.gov ID: NCT01444027
Acronym / sponsor ID: 36909
Conditions: Hospice Informal Caregivers
Study type: Interventional
Recruitment status: Completed
Enrolment: 514 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: Oct 2011
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 30 Sep 2011 (estimated)
Results: Posted 20 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Attention Control	No intervention	–This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
Intervention Group 1 (Face to Face)	Experimental	Behavioral: Problem Solving TherapyThis group receives Problem Solving Therapy in face to face visits.
Intervention Group 2 (Video)	Experimental	Behavioral: Problem Solving TherapyThis group receives Problem Solving Therapy via video.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

enrolled as a family/informal caregiver of a hospice patient
18 years or older
with access to a standard phone line or Internet and computer access at home
without functional hearing loss or with a hearing aid that allows the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver)
no or only mild cognitive impairment

Key exclusion criteria (1 listed)

lack of phone or Internet access

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
Problem Solving TherapyProblem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.	Behavioural	Intervention Group 1 (Face to Face), Intervention Group 2 (Video)

Primary outcome

Caregiver Anxiety: Change From Baseline to Post-Intervention Exit
Time frame: At Baseline and Exit (approximately 4 weeks after recruitment)
Caregiver anxiety was measured with the 7-item Generalized Anxiety Disorder (GAD-7) Scale (Spitzer et al., 2006), which measures the frequency with which respondents experience symptoms of anxiety such as restlessness, difficulty relaxing, and uncontrollable worrying. The GAD-7 total scores range from 0 to 21, with higher scores indicating more anxiety.
Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit
Time frame: At Baseline and Exit (approximately 4 weeks after recruitment)
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better physical quality of life.
Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit
Time frame: At Baseline and Exit (approximately 4 weeks after recruitment)
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better social quality of life.
Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit
Time frame: At Baseline and Exit (approximately 4 weeks after recruitment)
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better emotional quality of life.
Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit
Time frame: At Baseline and Exit (approximately 4 weeks after recruitment)
An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better financial quality of life.

Results and safety

Results posted to the registry on 20 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Attention Control	172	142
Intervention Group 1 (Face to Face)	171	141
Intervention Group 2 (Video)	171	133

Primary outcome: Caregiver Anxiety: Change From Baseline to Post-Intervention Exit

Time frame: At Baseline and Exit (approximately 4 weeks after recruitment). Mean (Standard Error). Unit: units on a scale

Measure	Attention Control n = 172	Intervention Group 1 (Face to Face) n = 171	Intervention Group 2 (Video) n = 171
Value	-0.9 (0.3)	-2.0 (0.4)	-0.7 (0.4)

Attention Control vs Intervention Group 1 (Face to Face): p = 0.002, Regression, Linear
Attention Control vs Intervention Group 2 (Video): p = 0.90, Regression, Linear
Intervention Group 1 (Face to Face) vs Intervention Group 2 (Video): p = 0.002, Regression, Linear

Population analysed: Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.

Primary outcome: Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit

Time frame: At Baseline and Exit (approximately 4 weeks after recruitment). Mean (Standard Error). Unit: units on a scale

Measure	Attention Control n = 172	Intervention Group 1 (Face to Face) n = 171	Intervention Group 2 (Video) n = 171
Value	-0.4 (0.1)	0.2 (0.1)	-0.2 (0.1)

Attention Control vs Intervention Group 1 (Face to Face): p = 0.001, Regression, Linear
Attention Control vs Intervention Group 2 (Video): p = 0.48, Regression, Linear
Intervention Group 1 (Face to Face) vs Intervention Group 2 (Video): p = .01, Regression, Linear

Population analysed: Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.

Primary outcome: Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit

Time frame: At Baseline and Exit (approximately 4 weeks after recruitment). Mean (Standard Error). Unit: units on a scale

Measure	Attention Control n = 172	Intervention Group 1 (Face to Face) n = 171	Intervention Group 2 (Video) n = 171
Value	-0.2 (0.2)	0.2 (0.1)	-0.4 (0.2)

Attention Control vs Intervention Group 1 (Face to Face): p = 0.001, Regression, Linear
Attention Control vs Intervention Group 2 (Video): p = 0.83, Regression, Linear
Intervention Group 1 (Face to Face) vs Intervention Group 2 (Video): p = 0.001, Regression, Linear

Population analysed: Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.

Primary outcome: Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit

Time frame: At Baseline and Exit (approximately 4 weeks after recruitment). Mean (Standard Error). Unit: units on a scale

Measure	Attention Control n = 172	Intervention Group 1 (Face to Face) n = 171	Intervention Group 2 (Video) n = 171
Value	-0.1 (0.2)	0.4 (0.1)	0.0 (0.2)

Attention Control vs Intervention Group 1 (Face to Face): p = 0.003, Regression, Linear
Attention Control vs Intervention Group 2 (Video): p = 0.16, Regression, Linear
Intervention Group 1 (Face to Face) vs Intervention Group 2 (Video): p = 0.17, Regression, Linear

Population analysed: Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Attention Control	0 of 172 (0%)	0 of 172 (0%)	0 of 172
Intervention Group 1 (Face to Face)	0 of 171 (0%)	0 of 171 (0%)	0 of 171
Intervention Group 2 (Video)	0 of 272 (0%)	0 of 171 (0%)	0 of 171

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34793244Starr LT, Bullock K, Washington K, Aryal S, Parker Oliver D, Demiris G. Anxiety, Depression, Quality of Life, Caregiver Burden, and Perceptions of Caregiver-Centered Communication among Black and White Hospice Family Caregivers. J Palliat Med. 2022 Apr;25(4):596-605. doi: 10.1089/jpm.2021.0302. Epub 2021 Nov 18.
Derived from this study: PubMed 30946495Demiris G, Oliver DP, Washington K, Pike K. A Problem-Solving Intervention for Hospice Family Caregivers: A Randomized Clinical Trial. J Am Geriatr Soc. 2019 Jul;67(7):1345-1352. doi: 10.1111/jgs.15894. Epub 2019 Apr 4.
Derived from this study: PubMed 30773970Benson JJ, Parker Oliver D, Demiris G, Washington K. Accounts of Family Conflict in Home Hospice Care: The Central Role of Autonomy for Informal Caregiver Resilience. J Fam Nurs. 2019 May;25(2):190-218. doi: 10.1177/1074840719828091. Epub 2019 Feb 17.
Derived from this study: PubMed 27303062Tarter R, Demiris G, Pike K, Washington K, Parker Oliver D. Pain in Hospice Patients With Dementia: The Informal Caregiver Experience. Am J Alzheimers Dis Other Demen. 2016 Sep;31(6):524-9. doi: 10.1177/1533317516653825. Epub 2016 Jun 14.
Derived from this study: PubMed 27048707Oliver DP, Demiris G, Washington KT, Clark C, Thomas-Jones D. Challenges and Strategies for Hospice Caregivers: A Qualitative Analysis. Gerontologist. 2017 Aug 1;57(4):648-656. doi: 10.1093/geront/gnw054.
Derived from this study: PubMed 26484426Washington KT, Pike KC, Demiris G, Parker Oliver D, Albright DL, Lewis AM. Gender Differences in Caregiving at End of Life: Implications for Hospice Teams. J Palliat Med. 2015 Dec;18(12):1048-53. doi: 10.1089/jpm.2015.0214. Epub 2015 Oct 20.
Derived from this study: PubMed 25547480Washington KT, Pike KC, Demiris G, Oliver DP. Unique characteristics of informal hospice cancer caregiving. Support Care Cancer. 2015 Jul;23(7):2121-8. doi: 10.1007/s00520-014-2570-z. Epub 2014 Dec 30.
Derived from this study: PubMed 25369725Washington KT, Wittenberg-Lyles E, Oliver DP, Baldwin PK, Tappana J, Wright JH, Demiris G. Rethinking family caregiving: tailoring cognitive-behavioral therapies to the hospice experience. Health Soc Work. 2014 Nov;39(4):244-50. doi: 10.1093/hsw/hlu031.
Derived from this study: PubMed 24524662Washington KT, Demiris G, Pike KC, Kruse RL, Oliver DP. Anxiety among informal hospice caregivers: an exploratory study. Palliat Support Care. 2015 Jun;13(3):567-73. doi: 10.1017/S1478951513001193. Epub 2014 Feb 13.
Derived from this study: PubMed 23558847Demiris G, Parker Oliver D, Capurro D, Wittenberg-Lyles E. Implementation science: implications for intervention research in hospice and palliative care. Gerontologist. 2014 Apr;54(2):163-71. doi: 10.1093/geront/gnt022. Epub 2013 Apr 4.

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.

George Demiris, PhD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Problem Solving Therapy in people with Hospice Informal Caregivers, run by University of Washington 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 6 inclusion and 1 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 13 Dec 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. 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?

Yes. Results are posted in the registry (first posted 20 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Caregiver Anxiety: Change From Baseline to Post-Intervention Exit (time frame: At Baseline and Exit (approximately 4 weeks after recruitment)). 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 NCT01444027, which also lists 10 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 13 Dec 2017.