Trial Outcomes & Findings for Savvy System Project (NCT NCT04060355)

Last Updated: 2024-12-30

Results Overview

The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week. It includes 20 items comprising six scales reflecting major facets of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

Baseline, Month 6

Results posted on

2024-12-30

Participant Flow

120 family caregivers who took part in Savvy Caregiver programs led by interventionists trained by the online training program developed in this project consented to be part of the study and provided baseline data. These caregivers were recruited from 37 Savvy Caregiver programs offered by 23 of the trained interventionists from 13 agencies located in 5 states. The first caregiver enrolled on 8/04/21. The last caregiver data collection point occurred on 09/27/2023

Participant milestones

Participant milestones
Measure	Savvy Participants Using an on-line survey method, each caregiver will be asked to complete the post-program fidelity monitoring survey that seeks responses to the program (feel more knowledgeable, more competent, better equipped, etc.) and asks them to assess the interventionist's performance and verify that certain key elements of the program were covered. Savvy program: Caregiver program (Savvy) is an evidence-based dementia family caregiver psychoeducation program. Provided to groups of 8-12 (typically) individuals caring for family members living with Alzheimer's disease or related dementias (PLWD), Savvy employs a mechanism of action based in Social Cognitive theory to promote caregivers' solution-focused coping behaviors through the acquisition of appropriate knowledge, skills, and outlook and the enhancement of caregiving mastery.
Overall Study STARTED	120
Overall Study COMPLETED	79
Overall Study NOT COMPLETED	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Savvy Participants Using an on-line survey method, each caregiver will be asked to complete the post-program fidelity monitoring survey that seeks responses to the program (feel more knowledgeable, more competent, better equipped, etc.) and asks them to assess the interventionist's performance and verify that certain key elements of the program were covered. Savvy program: Caregiver program (Savvy) is an evidence-based dementia family caregiver psychoeducation program. Provided to groups of 8-12 (typically) individuals caring for family members living with Alzheimer's disease or related dementias (PLWD), Savvy employs a mechanism of action based in Social Cognitive theory to promote caregivers' solution-focused coping behaviors through the acquisition of appropriate knowledge, skills, and outlook and the enhancement of caregiving mastery.
Overall Study Lost to Follow-up	41

Baseline Characteristics

Savvy System Project

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Savvy Participants n=120 Participants Using an on-line survey method, each caregiver will be asked to complete the post-program fidelity monitoring survey that seeks responses to the program (feel more knowledgeable, more competent, better equipped, etc.) and asks them to assess the interventionist's performance and verify that certain key elements of the program were covered. Savvy program: Caregiver program (Savvy) is an evidence-based dementia family caregiver psychoeducation program. Provided to groups of 8-12 (typically) individuals caring for family members living with Alzheimer's disease or related dementias (PLWD), Savvy employs a mechanism of action based in Social Cognitive theory to promote caregivers' solution-focused coping behaviors through the acquisition of appropriate knowledge, skills, and outlook and the enhancement of caregiving mastery.
Age, Customized Age 33- 83	67.9 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	98 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	105 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Relationship to PLWD (People living with Dementia) Spouse	70 Participants n=5 Participants
Relationship to PLWD (People living with Dementia) Child/ Other Relative	43 Participants n=5 Participants
Relationship to PLWD (People living with Dementia) Sibling/ Friend/ Other	7 Participants n=5 Participants
Live with PLWD: Yes	91 Participants n=5 Participants
Employed outside home: No	88 Participants n=5 Participants
Any other help with caregiving: Yes	75 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 6

Outcome measures

Outcome measures
Measure	Savvy Participants n=120 Participants Using an on-line survey method, each caregiver will be asked to complete the post-program fidelity monitoring survey that seeks responses to the program (feel more knowledgeable, more competent, better equipped, etc.) and asks them to assess the interventionist's performance and verify that certain key elements of the program were covered. Savvy program: Caregiver program (Savvy) is an evidence-based dementia family caregiver psychoeducation program. Provided to groups of 8-12 (typically) individuals caring for family members living with Alzheimer's disease or related dementias (PLWD), Savvy employs a mechanism of action based in Social Cognitive theory to promote caregivers' solution-focused coping behaviors through the acquisition of appropriate knowledge, skills, and outlook and the enhancement of caregiving mastery.
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score Baseline	13.2 score on a scale Standard Deviation 9.1
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score Month 6	79 score on a scale Standard Deviation 11.0

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: The analysis population includes participants who completed the required assessment at follow-up appointments.

State-Trait Anxiety Inventory scale - 20-item 4-point Likert scale is sensitive to changes in transitory anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" (0) to "Almost Always" (3)); Range: 0-60. Higher scores indicate greater anxiety.

Outcome measures

Outcome measures
Measure	Savvy Participants n=120 Participants Using an on-line survey method, each caregiver will be asked to complete the post-program fidelity monitoring survey that seeks responses to the program (feel more knowledgeable, more competent, better equipped, etc.) and asks them to assess the interventionist's performance and verify that certain key elements of the program were covered. Savvy program: Caregiver program (Savvy) is an evidence-based dementia family caregiver psychoeducation program. Provided to groups of 8-12 (typically) individuals caring for family members living with Alzheimer's disease or related dementias (PLWD), Savvy employs a mechanism of action based in Social Cognitive theory to promote caregivers' solution-focused coping behaviors through the acquisition of appropriate knowledge, skills, and outlook and the enhancement of caregiving mastery.
Change in Anxiety Score Baseline	34.9 score on a scale Standard Deviation 10.2
Change in Anxiety Score Month 6	35.3 score on a scale Standard Deviation 11.5

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: The analysis population includes participants who completed the required assessment at follow-up appointments.

Zarit Burden Inventory (ZBI) score is a 22-item Likert scale. Each item is a statement which the caregiver is asked to endorse using a 5-point scale, scored "Never" (0) to "Nearly Always" (4); Range: 0-88. Total score is obtained by summing all items endorsed. Higher scores indicate greater perceived burden.

Outcome measures

Outcome measures
Measure	Savvy Participants n=120 Participants Using an on-line survey method, each caregiver will be asked to complete the post-program fidelity monitoring survey that seeks responses to the program (feel more knowledgeable, more competent, better equipped, etc.) and asks them to assess the interventionist's performance and verify that certain key elements of the program were covered. Savvy program: Caregiver program (Savvy) is an evidence-based dementia family caregiver psychoeducation program. Provided to groups of 8-12 (typically) individuals caring for family members living with Alzheimer's disease or related dementias (PLWD), Savvy employs a mechanism of action based in Social Cognitive theory to promote caregivers' solution-focused coping behaviors through the acquisition of appropriate knowledge, skills, and outlook and the enhancement of caregiving mastery.
Change in Zarit Burden Inventory (ZBI) Score Baseline	35.9 score on a scale Standard Deviation 14.2
Change in Zarit Burden Inventory (ZBI) Score Month 6	35.2 score on a scale Standard Deviation 13.4

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: The analysis population includes participants who completed the required assessment at follow-up appointments.

The Pearlin Mastery (PM) scale measures the extent to which an individual regards their life chances as being under their personal control rather than fatalistically ruled. Response options: 4-point Likert scale, 1,"Strongly disagree" and 4,"Strongly agree". Items are summed, yielding a range from 7 to 28. Higher scores indicate greater levels of mastery.

Outcome measures

Outcome measures
Measure	Savvy Participants n=120 Participants Using an on-line survey method, each caregiver will be asked to complete the post-program fidelity monitoring survey that seeks responses to the program (feel more knowledgeable, more competent, better equipped, etc.) and asks them to assess the interventionist's performance and verify that certain key elements of the program were covered. Savvy program: Caregiver program (Savvy) is an evidence-based dementia family caregiver psychoeducation program. Provided to groups of 8-12 (typically) individuals caring for family members living with Alzheimer's disease or related dementias (PLWD), Savvy employs a mechanism of action based in Social Cognitive theory to promote caregivers' solution-focused coping behaviors through the acquisition of appropriate knowledge, skills, and outlook and the enhancement of caregiving mastery.
Change in Caregiver Pearlin Mastery Score Baseline	11.5 score on a scale Standard Deviation 2.1
Change in Caregiver Pearlin Mastery Score Month 6	12.7 score on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: The analysis population includes participants who completed the required assessment at follow-up appointments.

Revised Memory and Behavior Problem Checklist is a 24-item two-part Likert scale that assesses (Part 1) caregiver reported frequency of patient behaviors and (Part 2) caregiver's responreaction to each behavior, or the extent of distress experienced. The frequency of behaviors is assessed based on a Likert-scale of 0 to (0 = never occurs, 1 = occurs infrequently and not in the last week, 2 = occurred 1-2 times in the last week, 3 = occurred 3-6 times in the last week, and 4 = occurs daily or more often); Range: 0-96. Reactions are assessed by asking how" upsetting" the behavior was on a Likert scale of 0 to 4 (0 = Not at all, 1= a little, 2 = moderately, 3 = very much, and 4 =extremely); Range: 0-96. The two parts of the scale yield a summary score - higher scores indicate higher frequency of patient behaviors and greater levels of caregiver distress, respectively.

Outcome measures

Outcome measures
Measure	Savvy Participants n=120 Participants Using an on-line survey method, each caregiver will be asked to complete the post-program fidelity monitoring survey that seeks responses to the program (feel more knowledgeable, more competent, better equipped, etc.) and asks them to assess the interventionist's performance and verify that certain key elements of the program were covered. Savvy program: Caregiver program (Savvy) is an evidence-based dementia family caregiver psychoeducation program. Provided to groups of 8-12 (typically) individuals caring for family members living with Alzheimer's disease or related dementias (PLWD), Savvy employs a mechanism of action based in Social Cognitive theory to promote caregivers' solution-focused coping behaviors through the acquisition of appropriate knowledge, skills, and outlook and the enhancement of caregiving mastery.
Change in Revised Memory and Behavior Problem Checklist Score Baseline Frequency	38.7 score on a scale Standard Deviation 12.2
Change in Revised Memory and Behavior Problem Checklist Score Month 6 Frequency	36.6 score on a scale Standard Deviation 11.8
Change in Revised Memory and Behavior Problem Checklist Score Baseline Reaction	19.7 score on a scale Standard Deviation 11.9
Change in Revised Memory and Behavior Problem Checklist Score Month 6 Reaction	17.0 score on a scale Standard Deviation 11.0

Adverse Events

Savvy Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kenneth Hepburn, PhD

Emory University, School of Nursing

Phone: 404-712-9286

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place