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How do varying levels of participation in selecting self-management interventions (ranging from no input into the selection to selection based on need or preference) affect health risks and physical and mental health over time in family caregivers of persons with Alzheimer's and other dementia disorders? Caregivers will be randomized to 1) information on diversional activities (attention control); 2) self-management intervention based on need (SM-need); or 3) self-management intervention of their preference (SM-preference).
The study has two aims: The primary aim (A1) is to examine differences across the three groups (attention control, SM-need, and SM-preference) on caregiver health (health risks and mental and physical health) over time. The investigators hypothesize that the caregivers who receive a self-management intervention based on need (SM-need) or preference (SM-preference) will have better health outcomes than those in the attention control.
Secondary aims are to: A2) explore whether caregiver baseline need or preference for intervention (i.e. choice) is associated with: a) care recipient's symptoms; b) caregiver reactions; and c) caregiving involvement, and A3) build caregiver profiles from demographic/ contextual factors that are associated with their needs and preferences for the self-management interventions.
All caregivers will complete assessment measures and measures of health risks, and physical and mental health at baseline (T1), about 6 months (T2), and about 12 months (T3). Caregivers will be randomly assigned to one of three groups. The attention control group will receive information on diversional activities. The SM-need group will receive a self-management intervention for biofeedback training or resourcefulness training, as determined by baseline cut scores. Caregivers in the SM-preference group will choose one of the two self-management interventions according to their personal preference.
Both self-management interventions (biofeedback training, resourcefulness training) and the diversional activities, are delivered over four weeks (between T1 and T2). Caregivers may use the intervention whenever and as often as they wish (i.e. self-tailoring) for the remainder of the study period. These resourcefulness training includes teaching self-help (stress-management, problem-solving) and help-seeking skills, respectively. Biofeedback training consists of the use of a hand-held device that shows the participant their changes in heart rate based on changes in their breathing pattern (as they relax); caregivers who need or prefer the biofeedback will be given a device to use for 28 days. All study participants receiving the intervention will also be asked to keep a journal to record their experience with the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-management intervention based on Need | Active Comparator | Participants randomly assigned to this arm receive a self-management intervention (Resourcefulness Training or Biofeedback) according to baseline data. |
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| Self-management intervention based on Preference | Active Comparator | Participants randomly assigned to this arm receive a self-management intervention (Resourcefulness Training or Biofeedback) according to their preference. |
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| Attention Control: Diversonal Activities | Placebo Comparator | Participants randomly assigned to this arm will be presented with diversional activities. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resourcefulness training | Behavioral | Resourcefulness training is a cognitive behavioral intervention that consists of teaching and reinforcing personal (self-help) and social (help-seeking) strategies to overcome adversity. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Caregiver's Perceived Stress Scale | 14 items; 3-point scale; Scores range 9-27; higher score indicates greater perceived stress | From T1 (baseline) to T2 (6 months) through T3 (one year) |
| Change in Caregiver's Negative Emotions Checklist | 10 items; dichotomous list; Scores range 0-10; higher score indicates more negative emotions. | From T1 (baseline) to T2 (6 months) through T3 (one year) |
| Change in Caregiver's Depressive Cognitions Scales | 8 items; 6-point scale; Scores range 0-40; higher score indicates higher depressive cognition | From T1 (baseline) to T2 (6 months) through T3 (one year) |
| Change in Global Health - Physical Health: PROMIS (Patient Reported Outcomes Measurement Information System) | Change in self-assessment of general physical health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life. | From T1 (baseline) to T2 (6 months) through T3 (one year) |
| Change in Caregiver Global Health - Mental Health: PROMIS (Patient Reported Outcomes Measurement Information System) | Change in self-assessment of general mental health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life. | From T1 (baseline) to T2 (6 months) through T3 (one year) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaclene A Zauszniewski, PhD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CWRU School of Nursing | Cleveland | Ohio | 44106 | United States |
Enrolled participants may be excluded if they elect not to participate after enrolling.
Family carers of elders with dementia will be recruited using various strategies (community support organizations, publicly posted flyers, online ads) in NE Ohio. Eligible participants were adults over the age of 18, who were carers of a family member (over the age of 65) with a medical diagnosis of dementia, and had transitioned to a new phase of caring in the previous 6 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Need | Participants will be assigned to either Resourcefulness Training or HRV-focused Biofeedback interventions based on their need (as determined by baseline data). Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills. Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Feb 1, 2023 |
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Participants were aware of which intervention they were receiving (Resourcefulness Training, HRV-focused BioFeedback, Attention Control: Diversonal Activities, but were not aware of which arm they had been randomly assigned to, or whether their intervention was an active or placebo comparator. The PI and Outcomes Assessor were blinded as to the identity of individual participants, and, during data collection, which participants had been assigned to which arm/intervention. In order to complete study aims, variables indicating arm and intervention assignment were included in the final data file.
| Biofeedback | Behavioral | Biofeedback training combines teaching slow, deep, paced breathing with real-time tracking to increase an individual's heart rate variability and ultimately improve self-regulation. |
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| Attention Control | Behavioral | Participants randomly assigned to this intervention will receive suggested Diversional Activities, presented in an audiovisual format. |
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| Change in Caregiver's Health Risk Behavior Scale |
Measure of Caregiving Health Risks: 9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk |
| From T1 (baseline) to T2 (6 months) through T3 (one year) |
| FG001 | Preference | Participants will be given a choice of Resourcefulness Training or HRV-focused Biofeedback interventions. Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills. Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior. |
| FG002 | Attention Control | Participants assigned to the attention control group will be presented with Diversionary activities. Diversional Activites: An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc. |
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| NOT COMPLETED |
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All participants who consented and completed the baseline questionnaire.
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| ID | Title | Description |
|---|---|---|
| BG000 | Need | Participants in this arm were, at enrollment, caregivers (in the home), care partners (with a care facility), or caretakers (bereaved) of persons with dementia. Those in this randomly assigned group were given a choice to participate in one of two self-management interventions (either biofeedback or resourcefulness training). |
| BG001 | Preference | Participants in this arm were, at enrollment, caregivers (in the home), care partners (with a care facility), or caretakers (bereaved) of persons with dementia. Those in this randomly assigned group were given a choice to participate in one of two self-management interventions (either biofeedback or resourcefulness training). |
| BG002 | Attention Control | Participants in this arm were, at enrollment, caregivers (in the home), care partners (with a care facility), or caretakers (bereaved) of persons with dementia. Those in this randomly assigned group participated in diversional activities. |
| BG003 | Total | Total of all reporting groups |
| 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, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Change in Caregiver's Perceived Stress Scale | 14 items; 3-point scale; Scores range 9-27; higher score indicates greater perceived stress | The overall analyzed participants included all who completed the T3 questionnaire across the three arms. 15 participants in each arm discontinued their participation between baseline (T1) and T3. Thus, this number equals 308 (who completed baseline measures) minus 45 (who dropped out over time) which equals 263 at T3. | Posted | Mean | Standard Deviation | score on a scale | From T1 (baseline) to T2 (6 months) through T3 (one year) |
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| Primary | Change in Caregiver's Negative Emotions Checklist | 10 items; dichotomous list; Scores range 0-10; higher score indicates more negative emotions. | The overall analyzed participants included all who completed the T3 questionnaire across the three arms. 15 participants in each arm discontinued their participation between baseline (T1) and T3. Thus, this number equals 308 (who completed baseline measures) minus 45 (who dropped out over time) which equals 263 at T3 | Posted | Mean | Standard Deviation | score on a scale | From T1 (baseline) to T2 (6 months) through T3 (one year) |
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| Primary | Change in Caregiver's Depressive Cognitions Scales | 8 items; 6-point scale; Scores range 0-40; higher score indicates higher depressive cognition | The overall analyzed participants included all who completed the T3 questionnaire across the three arms. 15 participants in each arm discontinued their participation between baseline (T1) and T3. Thus, this number equals 308 (who completed baseline measures) minus 45 (who dropped out over time) which equals 263 at T3 | Posted | Mean | Standard Deviation | score on a scale | From T1 (baseline) to T2 (6 months) through T3 (one year) |
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| Primary | Change in Global Health - Physical Health: PROMIS (Patient Reported Outcomes Measurement Information System) | Change in self-assessment of general physical health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life. | The overall analyzed participants included all who completed the T3 questionnaire across the three arms. 15 participants in each arm discontinued their participation between baseline (T1) and T3. Thus, this number equals 308 (who completed baseline measures) minus 45 (who dropped out over time) which equals 263 at T3 | Posted | Mean | Standard Deviation | score on a scale | From T1 (baseline) to T2 (6 months) through T3 (one year) |
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| Primary | Change in Caregiver Global Health - Mental Health: PROMIS (Patient Reported Outcomes Measurement Information System) | Change in self-assessment of general mental health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life. | All participants who completed the T3 questionnaire. | Posted | Mean | Standard Deviation | score on a scale | From T1 (baseline) to T2 (6 months) through T3 (one year) |
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| Primary | Change in Caregiver's Health Risk Behavior Scale | Measure of Caregiving Health Risks: 9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk | The overall analyzed participants included all who completed the T3 questionnaire across the three arms. 15 participants in each arm discontinued their participation between baseline (T1) and T3. Thus, this number equals 308 (who completed baseline measures) minus 45 (who dropped out over time) which equals 263 at T3 | Posted | Mean | Standard Deviation | score on a scale | From T1 (baseline) to T2 (6 months) through T3 (one year) |
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Data was collected for the duration of the study (one year post-baseline questionnaire).
All events would have been reported. No adverse events occurred.
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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 | Need | Participants will be assigned to either Resourcefulness Training or HRV-focused Biofeedback interventions based on their need (as determined by baseline data). Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills. Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior. | 0 | 105 | 0 | 105 | 0 | 105 |
| EG001 | Preference | Participants will be given a choice of Resourcefulness Training or HRV-focused Biofeedback interventions. Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills. Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior. | 0 | 100 | 0 | 100 | 0 | 100 |
| EG002 | Attention Control | Participants assigned to the attention control group will be presented with Diversionary activities. Diversional Activites: An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc. | 0 | 103 | 0 | 103 | 0 | 103 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaclene Zauszniewski, PhD | Case Western Reserve University | 216.368.3612 | jaz@case.edu |
| Jan 29, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| T3 (1 year post baseline) |
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| OG002 | Attention Control | Participants assigned to the attention control group will be presented with Diversionary activities. Diversional Activites: An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc. |
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| OG002 | Attention Control | Participants assigned to the attention control group will be presented with Diversionary activities. Diversional Activites: An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc. |
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| OG002 |
| Attention Control: Diversonal Activities |
Participants randomly assigned to this arm will be presented with diversional activities. Attention Control: Participants randomly assigned to this intervention will receive suggested Diversional Activities, presented in an audiovisual format. |
|
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Participants will be given a choice of Resourcefulness Training or HRV-focused Biofeedback interventions.
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
| OG002 | Attention Control | Participants assigned to the attention control group will be presented with Diversionary activities. Diversional Activites: An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc. |
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| OG002 | Attention Control | Participants assigned to the attention control group will be presented with Diversionary activities. Diversional Activites: An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc. |
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