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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR012213-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Intervention Group 2 (Video) | Experimental | This group receives Problem Solving Therapy via video. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Problem Solving Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Demiris, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34793244 | Derived | 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. | |
| 30946495 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Attention Control | This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group. |
| FG001 | Intervention Group 1 (Face to Face) | This group receives Problem Solving Therapy in face to face visits. Problem Solving Therapy: 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. |
| FG002 | Intervention Group 2 (Video) | This group receives Problem Solving Therapy via video. Problem Solving Therapy: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Attention Control | This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group. |
| BG001 | Intervention Group 1 (Face to Face) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data. | Posted | Mean | Standard Error | units on a scale | At Baseline and Exit (approximately 4 weeks after recruitment) |
|
3 months
Caregivers are participants in this study and all cause mortality is reported for them, not their loved one receiving hospice care
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Attention Control | This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. George Demiris | University of Washington, School of Nursing | 206-221-3866 | gdemiris@uw.edu |
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| At Baseline and Exit (approximately 4 weeks after recruitment) |
| 30773970 | Derived | 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. |
| 27303062 | Derived | 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. |
| 27048707 | Derived | 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. |
| 26484426 | Derived | 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. |
| 25547480 | Derived | 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. |
| 25369725 | Derived | 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. |
| 24524662 | Derived | 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. |
| 23558847 | Derived | 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. |
This group receives Problem Solving Therapy in face to face visits.
Problem Solving Therapy: 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.
| BG002 | Intervention Group 2 (Video) | This group receives Problem Solving Therapy via video. Problem Solving Therapy: 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Intervention Group 1 (Face to Face) | This group receives Problem Solving Therapy in face to face visits. Problem Solving Therapy: 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. |
| OG002 | Intervention Group 2 (Video) | This group receives Problem Solving Therapy via video. Problem Solving Therapy: 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. |
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| Primary | 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. | Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data. | Posted | Mean | Standard Error | units on a scale | At Baseline and Exit (approximately 4 weeks after recruitment) |
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|
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| Primary | 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. | Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data. | Posted | Mean | Standard Error | units on a scale | At Baseline and Exit (approximately 4 weeks after recruitment) |
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|
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| Primary | 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. | Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data. | Posted | Mean | Standard Error | units on a scale | At Baseline and Exit (approximately 4 weeks after recruitment) |
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| Primary | 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. | Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data. | Posted | Mean | Standard Error | units on a scale | At Baseline and Exit (approximately 4 weeks after recruitment) |
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|
|
| 0 |
| 172 |
| 0 |
| 172 |
| 0 |
| 172 |
| EG001 | Intervention Group 1 (Face to Face) | This group receives Problem Solving Therapy in face to face visits. Problem Solving Therapy: 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. | 0 | 171 | 0 | 171 | 0 | 171 |
| EG002 | Intervention Group 2 (Video) | This group receives Problem Solving Therapy via video. Problem Solving Therapy: 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. | 0 | 171 | 0 | 272 | 0 | 171 |
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Adjusted for baseline value of the measure, hospice agency, and bereaved status. |
| 0.48 |
Bonferroni adjusted p-value for 3 pairwise comparisons. |
| Superiority |
| Regression, Linear | Adjusted for baseline value of the measure, hospice agency, and bereaved status. | .01 | Bonferroni adjusted p-value for 3 pairwise comparisons. | Superiority |
Adjusted for baseline value of the measure, hospice agency, and bereaved status. |
| 0.83 |
| Superiority |
| Regression, Linear | Adjusted for baseline value of the measure, hospice agency, and bereaved status. | 0.001 | Bonferroni adjusted p-value for 3 pairwise comparisons. | Superiority |
Adjusted for baseline value of the measure, hospice agency, and bereaved status. |
| 0.16 |
Bonferroni adjusted p-value for 3 pairwise comparisons. |
| Superiority |
| Regression, Linear | Adjusted for baseline value of the measure, hospice agency, and bereaved status. | 0.17 | Bonferroni adjusted p-value for 3 pairwise comparisons. | Superiority |
Adjusted for baseline value of the measure, hospice agency, and bereaved status. |
| 0.78 |
Bonferroni adjusted p-value for 3 pairwise comparisons. |
| Superiority |
| Regression, Linear | Adjusted for baseline value of the measure, hospice agency, and bereaved status. | 0.004 | Bonferroni adjusted p-value for 3 pairwise comparisons. | Superiority |