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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30NR018093 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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This research is being done to learn whether services to the caregiver to provide emotional, instrumental and social support can improve quality of life and other outcomes. The Caregiver-Support program provides services that are not usually available to caregivers of persons with heart failure and other chronic conditions.
Family caregivers who care for older adults living with multiple chronic conditions, including heart failure (HF), provide substantial cost savings to the US healthcare system. While caregiving can be meaningful and rewarding, extensive research also demonstrates high rates of chronic disease, fatigue and physiologic measures such as stress hormones among caregivers. Family caregivers are often left juggling caregivers' loved one's healthcare as well as caregivers' own. Unmet needs have been identified including increased stress, financial strain and social isolation, but interventions to address these needs in HF caregivers have had mixed results. Due to the limited impact of many caregiver interventions, experts have called for a greater understanding of the dynamic and contextual factors of family caregiving including resources, needs and social support with an increased focus on individualization of interventions for high-risk caregivers to improve outcomes.Following a mixed methods study to better understand these contextual factors and to address this gap between the evidence and uptake of proven strategies by caregivers, the study team has developed a resilience-promoting intervention to improve quality of life for family caregivers of individuals with multiple chronic conditions, including HF, Caregiver-Support. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network.
The first phase of the study will be an open label pilot (N=5) followed by a single-masked, two-group, randomized trial (N=40) to test the feasibility and gauge an initial effect size of the intervention. Participants will be visited by study staff in participants' homes for all data collection and intervention visits. Participants will be randomized to receive either the immediate intervention group or the waitlist control group. In the waitlist control group, participants will receive usual care for the first 16 weeks (which is limited to printed materials provided in the clinic) and then begin the intervention.
The intervention will consist of 5 in-home sessions with a nurse interventionist. Each participant will receive each intervention component but interventionists will systematically tailor content to the participants' goals based on protocols. All participants will be reassessed at 16 weeks (in person) and 32 weeks (by phone) by a research assistant (RA) masked to treatment condition. The primary outcome will be improvement in quality of life between baseline and 16 weeks. Other endpoints include group differences in fatigue, caregiver burden, self-reported and physiological measures of resilience up through 32 weeks after the intervention. The investigators will also examine the acceptability of the intervention using intervention compliance and participant satisfaction data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Group | Experimental | In this arm, 5 participants will be enrolled in the intervention without blinding or randomization. The intervention and study delivery will be improved based on findings from this arm. |
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| Waitlist Control | Other | The waitlist control group (n=20) will be provided written materials with community resources for caregivers during the first 16 weeks, then the intervention will begin. |
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| Immediate Intervention | Experimental | The immediate intervention group (n=20) will receive the intervention during weeks 0-16. There will be assessment at week 32 to examine maintenance on primary and secondary outcomes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caregiver-Support | Behavioral | intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as Assessed by the Short Form Health Survey | The Short Form Health Survey (36 items) measures self-rated quality of life using 8 sub-scales. Items are scored on a 0-100 range, with total scores averaged for each subscale. The eight domains are also averaged to create an overall score from 0-100. Higher scores indicate a more favorable health state. | 16 weeks and 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) | The PROMIS 7-item fatigue measure has a score range from 0-35 with higher scores indicating higher levels of fatigue. We use T-scores for analysis (where standard scores with a mean of 50 and standard deviation of 10 in the U.S. general population). | 16 weeks and 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Interleukin 6 (ng/mL) | Participants will wear a non-occlusive sweatpatch to collect interleukin 6. Higher levels of interleukin 6 suggest increased activation of inflammatory response and decreased resilience to stress. | Baseline, 16 weeks and 32 weeks |
| Change in Interleukin 10 (pg/ml) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martha Abshire, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Nursing | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35602009 | Background | Abshire Saylor M, Pavlovic NV, DeGroot L, Jajodia A, Hladek MD, Perrin N, Wolff J, Davidson PM, Szanton S. Strengths-building through life purpose, self-care goal setting and social support: Study protocol for Caregiver Support. Contemp Clin Trials Commun. 2022 May 5;28:100917. doi: 10.1016/j.conctc.2022.100917. eCollection 2022 Aug. | |
| 37707361 | Result | Abshire Saylor M, Pavlovic N, DeGroot L, Peeler A, Nelson KE, Perrin N, Gilotra NA, Wolff JL, Davidson PM, Szanton SL. Feasibility of a Multi-Component Strengths-Building Intervention for Caregivers of Persons With Heart Failure. J Appl Gerontol. 2023 Dec;42(12):2371-2382. doi: 10.1177/07334648231191595. Epub 2023 Sep 14. |
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Of the 38 enrolled participants, 3 withdrew and 8 were lost to follow up prior to baseline data collection and randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Pilot | This group was the first consented participants and was not randomized, but instead all participants received the intervention. Information from this group was used to test study procedures and make final minor changes to the intervention protocol. |
| FG001 | Immediate Intervention | The immediate intervention group (n=20) will receive the intervention during weeks 0-16. There will be assessment at week 32 to examine maintenance on primary and secondary outcomes. Caregiver-Support: intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network. |
| FG002 | Waitlist Control | The waitlist control group (n=20) will be provided written materials with community resources for caregivers during the first 16 weeks, then the intervention will begin. Caregiver-Support: intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Open Label Pilot |
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| Pilot Trial |
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Pilot | This group was the first consented participants and was not randomized, but instead all participants received the intervention. Information from this group was used to test study procedures and make final minor changes to the intervention protocol. |
| BG001 | Immediate Intervention |
| 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 | Quality of Life as Assessed by the Short Form Health Survey | The Short Form Health Survey (36 items) measures self-rated quality of life using 8 sub-scales. Items are scored on a 0-100 range, with total scores averaged for each subscale. The eight domains are also averaged to create an overall score from 0-100. Higher scores indicate a more favorable health state. | 1 open label pilot participant did not start the intervention after completing the baseline surveys and did not complete subsequent timepoints for the surveys. The open label pilot participants did not complete the 32 week data collection. | Posted | Mean | Standard Deviation | units on a scale | 16 weeks and 32 weeks |
|
32 weeks
We used the clinicaltrials.gov definition of adverse reporting
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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 | Waitlist Control | The waitlist control group was provided written materials with community resources for caregivers during the first 16 weeks, then the intervention began. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martha Abshire Saylor | Johns Hopkins University School of Nursing | 4433406201 | mabshir1@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2023 | Sep 15, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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The research assistant collecting data will be blinded to group assignment for each participant.
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| Caregiver Burden as Assessed by the Oberst Caregiving Burden Scale | The investigators will use the task difficulty and time caring subscales of the Oberst Caregiving Burden Scale, which include 15 likert scale items. Scores range from 15-75. Higher scores indicate greater task difficulty and more time spent on each task, higher burden. | 16 weeks and 32 weeks |
| Caregiver Burden as Assessed by the Zarit Caregiver Burden Interview (ZBI) | The ZBI is a 12 item measure with higher scores representing higher feelings of burden; the range of summed scores is 0-48. | 16 weeks and 32 weeks |
Participants will wear a non-occlusive sweatpatch to collect interleukin 10. Higher levels of interleukin 10 suggest increased activation of the anti-inflammatory response and increased resilience to stress. |
| Baseline, 16 weeks and 32 weeks |
| Change in Resilience to Stress as Assessed by Heart Rate Variability | Participants will touch a finger pad for 2-5 minutes to obtain heart rate variability. Heart rate variability is assessed through multiple calculations including: percentage of pairs of adjacent N-N intervals differing by more than 50 milliseconds (pNN50), high-frequency power (HF power), and low frequency to high frequency (LF/HF) ratio. Higher pNN50, HF power and LF/HF ratio levels suggest increased resilience to stress. | Baseline, 16 weeks and 32 weeks |
| NOT COMPLETED |
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The immediate intervention group received the intervention during weeks 0-16. There was an assessment at week 32 to examine maintenance on primary and secondary outcomes. Caregiver-Support: intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network. |
| BG002 | Waitlist Control | The waitlist control group was provided written materials with community resources for caregivers during the first 16 weeks, then the intervention began. |
| 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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| Caregiver Burden | The Zarit Caregiver Burden Interview is a 12 item measure with higher scores representing higher feelings of burden; the range of summed scores is 0-48. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life (mental) | The Short Form Health Survey (36 items) measures self-rated quality of life using 8 sub-scales. Items are scored on a 0-100 range, with total scores averaged for each subscale. The mental health component is an average of 4 sub-scale scores. Higher scores indicate a more favorable health state. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Immediate Intervention | The immediate intervention group received the intervention during weeks 0-16. There was an assessment at week 32 to examine maintenance on primary and secondary outcomes. Caregiver-Support: intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network. |
| OG002 | Waitlist Control | The waitlist control group was provided written materials with community resources for caregivers during the first 16 weeks, then the intervention began. |
|
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| Secondary | Fatigue as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) | The PROMIS 7-item fatigue measure has a score range from 0-35 with higher scores indicating higher levels of fatigue. We use T-scores for analysis (where standard scores with a mean of 50 and standard deviation of 10 in the U.S. general population). | 1 open label pilot participant did not start the intervention after completing the baseline surveys and did not complete subsequent timepoints for the surveys. The open label pilot participants did not complete the 32 week data collection. | Posted | Mean | Standard Deviation | units on a scale | 16 weeks and 32 weeks |
|
|
|
| Secondary | Caregiver Burden as Assessed by the Oberst Caregiving Burden Scale | The investigators will use the task difficulty and time caring subscales of the Oberst Caregiving Burden Scale, which include 15 likert scale items. Scores range from 15-75. Higher scores indicate greater task difficulty and more time spent on each task, higher burden. | 1 open label pilot participant did not start the intervention after completing the baseline surveys and did not complete subsequent timepoints for the surveys. The open label pilot participants did not complete the 32 week data collection. | Posted | Mean | Standard Deviation | units on a scale | 16 weeks and 32 weeks |
|
|
|
| Secondary | Caregiver Burden as Assessed by the Zarit Caregiver Burden Interview (ZBI) | The ZBI is a 12 item measure with higher scores representing higher feelings of burden; the range of summed scores is 0-48. | 1 open label pilot participant did not start the intervention after completing the baseline surveys and did not complete subsequent timepoints for the surveys. The open label pilot participants did not complete the 32 week data collection. | Posted | Mean | Standard Deviation | units on a scale | 16 weeks and 32 weeks |
|
|
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| Other Pre-specified | Change in Interleukin 6 (ng/mL) | Participants will wear a non-occlusive sweatpatch to collect interleukin 6. Higher levels of interleukin 6 suggest increased activation of inflammatory response and decreased resilience to stress. | Not Posted | Baseline, 16 weeks and 32 weeks | Participants |
| Other Pre-specified | Change in Interleukin 10 (pg/ml) | Participants will wear a non-occlusive sweatpatch to collect interleukin 10. Higher levels of interleukin 10 suggest increased activation of the anti-inflammatory response and increased resilience to stress. | Not Posted | Baseline, 16 weeks and 32 weeks | Participants |
| Other Pre-specified | Change in Resilience to Stress as Assessed by Heart Rate Variability | Participants will touch a finger pad for 2-5 minutes to obtain heart rate variability. Heart rate variability is assessed through multiple calculations including: percentage of pairs of adjacent N-N intervals differing by more than 50 milliseconds (pNN50), high-frequency power (HF power), and low frequency to high frequency (LF/HF) ratio. Higher pNN50, HF power and LF/HF ratio levels suggest increased resilience to stress. | Not Posted | Baseline, 16 weeks and 32 weeks | Participants |
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Immediate Intervention | The immediate intervention group received the intervention during weeks 0-16. There was an assessment at week 32 to examine maintenance on primary and secondary outcomes. Caregiver-Support: intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Open Label Pilot | This group was the first consented participants and was not randomized, but instead all participants received the intervention. Information from this group was used to test study procedures and make final minor changes to the intervention protocol. | 0 | 3 | 0 | 3 | 0 | 3 |
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| 32 weeks |
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| 32 weeks |
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| 32 weeks |
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