Trial Outcomes & Findings for Learning to PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia (NCT NCT04649164)
NCT ID: NCT04649164
Last Updated: 2023-01-25
Results Overview
A 7-item scale measuring the extent to which a participant sees life as being under his/her personal control vs. something that is fatalistically ruled. Scores range from 7 to 28, with higher scores indicating greater levels of mastery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
87 participants
Primary outcome timeframe
Pre- and post-mentor training; pre- and post-mentoring intervention for mentees (16 weeks)
Results posted on
2023-01-25
Participant Flow
Participant milestones
| Measure |
Focus Group Participants
Subjects participating in focus groups will be either:
1. caregiver mentees in our previous peer mentoring study
2. peer mentors and completed 16 weeks of mentoring in our previous peer mentoring study
3. current family caregivers of community-dwelling LBD patients in the Chicago area.
The investigators will conduct virtual focus groups using a password-protected videoconference platform. The informed consent process will take place online prior to the focus group. Focus groups will be led by a qualified neuropsychologist using open-ended questions. The aim of these groups is to revise and improve upon our previous peer mentor program's curriculum. Participants will be presented with the previous program's curriculum and a variety of proposed educational resources for inclusion in the revised curriculum. The investigators will obtain participants' feedback. Focus groups will be recorded and transcribed.
Focus group to provide feedback on educational materials and mentoring program: Participation in a 2-3 hour focus group to review pilot and revised materials and provide feedback
|
Peer Mentors
Mentors will attend one 6-7 hour virtual training session. Study expectations and logistics will be reviewed with each potential mentor prior to the training session via phone. Informed consent process will take place online via REDCap prior to the training session. Baseline data will be collected via online surveys. Next, mentors will receive training regarding topics including active listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on caregiver, practical approaches to symptom management, and caregiving issues. The study team will present the PERSEVERE curriculum and accompanying handbook. The team will solicit questions and lead roleplay conversations. Finally mentors will complete post-training assessments. Once all caregiver mentees (Arm 3) are recruited, the mentors will contact their mentees once weekly by phone for 16 weeks to deliver the PERSEVERE curriculum.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
Caregiver Mentees
Once Aim 2 is complete and mentors have been trained, caregiver mentees will be matched with mentors by relationship to LBD patient, then by sex and age, as much as possible. The study team will contact mentees once a match is available for them. The mentee will complete baseline primary and secondary outcome assessments online via REDCap, including: mastery and loneliness scales, Short Zarit Burden Interview, Hospital Anxiety and Depression Scale. The team will provide the mentor's contact information and send the PERSEVERE handbook. Mentoring pairs will begin the 16-week peer mentor program. Pairs will be expected to speak for \>15-30 minutes weekly, and to review that week's PERSEVERE topics in the handbook before or during each call to facilitate meaningful conversations. Mentors and mentees will complete online study diaries every 2 weeks. Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete postmentoring assessments online.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
36
|
32
|
|
Overall Study
COMPLETED
|
18
|
35
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
4
|
Reasons for withdrawal
| Measure |
Focus Group Participants
Subjects participating in focus groups will be either:
1. caregiver mentees in our previous peer mentoring study
2. peer mentors and completed 16 weeks of mentoring in our previous peer mentoring study
3. current family caregivers of community-dwelling LBD patients in the Chicago area.
The investigators will conduct virtual focus groups using a password-protected videoconference platform. The informed consent process will take place online prior to the focus group. Focus groups will be led by a qualified neuropsychologist using open-ended questions. The aim of these groups is to revise and improve upon our previous peer mentor program's curriculum. Participants will be presented with the previous program's curriculum and a variety of proposed educational resources for inclusion in the revised curriculum. The investigators will obtain participants' feedback. Focus groups will be recorded and transcribed.
Focus group to provide feedback on educational materials and mentoring program: Participation in a 2-3 hour focus group to review pilot and revised materials and provide feedback
|
Peer Mentors
Mentors will attend one 6-7 hour virtual training session. Study expectations and logistics will be reviewed with each potential mentor prior to the training session via phone. Informed consent process will take place online via REDCap prior to the training session. Baseline data will be collected via online surveys. Next, mentors will receive training regarding topics including active listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on caregiver, practical approaches to symptom management, and caregiving issues. The study team will present the PERSEVERE curriculum and accompanying handbook. The team will solicit questions and lead roleplay conversations. Finally mentors will complete post-training assessments. Once all caregiver mentees (Arm 3) are recruited, the mentors will contact their mentees once weekly by phone for 16 weeks to deliver the PERSEVERE curriculum.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
Caregiver Mentees
Once Aim 2 is complete and mentors have been trained, caregiver mentees will be matched with mentors by relationship to LBD patient, then by sex and age, as much as possible. The study team will contact mentees once a match is available for them. The mentee will complete baseline primary and secondary outcome assessments online via REDCap, including: mastery and loneliness scales, Short Zarit Burden Interview, Hospital Anxiety and Depression Scale. The team will provide the mentor's contact information and send the PERSEVERE handbook. Mentoring pairs will begin the 16-week peer mentor program. Pairs will be expected to speak for \>15-30 minutes weekly, and to review that week's PERSEVERE topics in the handbook before or during each call to facilitate meaningful conversations. Mentors and mentees will complete online study diaries every 2 weeks. Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete postmentoring assessments online.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
|
Overall Study
Participant's care recipient expired
|
0
|
0
|
2
|
Baseline Characteristics
Learning to PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia
Baseline characteristics by cohort
| Measure |
Focus Group Participants
n=19 Participants
Subjects participating in focus groups will be either:
1. caregiver mentees in our previous peer mentoring study
2. peer mentors and completed 16 weeks of mentoring in our previous peer mentoring study
3. current family caregivers of community-dwelling LBD patients in the Chicago area.
The investigators will conduct virtual focus groups using a password-protected videoconference platform. The informed consent process will take place online prior to the focus group. Focus groups will be led by a qualified neuropsychologist using open-ended questions. The aim of these groups is to revise and improve upon our previous peer mentor program's curriculum. Participants will be presented with the previous program's curriculum and a variety of proposed educational resources for inclusion in the revised curriculum. The investigators will obtain participants' feedback. Focus groups will be recorded and transcribed.
Focus group to provide feedback on educational materials and mentoring program: Participation in a 2-3 hour focus group to review pilot and revised materials and provide feedback
|
Peer Mentors
n=36 Participants
Mentors will attend one 6-7 hour virtual training session. Study expectations and logistics will be reviewed with each potential mentor prior to the training session via phone. Informed consent process will take place online via REDCap prior to the training session. Baseline data will be collected via online surveys. Next, mentors will receive training regarding topics including active listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on caregiver, practical approaches to symptom management, and caregiving issues. The study team will present the PERSEVERE curriculum and accompanying handbook. The team will solicit questions and lead roleplay conversations. Finally mentors will complete post-training assessments. Once all caregiver mentees (Arm 3) are recruited, the mentors will contact their mentees once weekly by phone for 16 weeks to deliver the PERSEVERE curriculum.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
Caregiver Mentees
n=32 Participants
Once Aim 2 is complete and mentors have been trained, caregiver mentees will be matched with mentors by relationship to LBD patient, then by sex and age, as much as possible. The study team will contact mentees once a match is available for them. The mentee will complete baseline primary and secondary outcome assessments online via REDCap, including: mastery and loneliness scales, Short Zarit Burden Interview, Hospital Anxiety and Depression Scale. The team will provide the mentor's contact information and send the PERSEVERE handbook. Mentoring pairs will begin the 16-week peer mentor program. Pairs will be expected to speak for \>15-30 minutes weekly, and to review that week's PERSEVERE topics in the handbook before or during each call to facilitate meaningful conversations. Mentors and mentees will complete online study diaries every 2 weeks. Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete postmentoring assessments online.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Age, Continuous
|
69 years
n=5 Participants
|
66 years
n=7 Participants
|
68 years
n=5 Participants
|
68 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
36 participants
n=7 Participants
|
32 participants
n=5 Participants
|
87 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre- and post-mentor training; pre- and post-mentoring intervention for mentees (16 weeks)Population: 35 mentors trained; we intentionally overrecruited peer mentors in order to ensure an adequate number of mentors who could be matched with caregiver mentees. We matched each of 30 mentees with one mentor, such that 5 mentors were trained but did not complete the 16 weeks of mentoring (effectively, "backup" mentors). This outcome was NOT assessed in the focus group arm.
A 7-item scale measuring the extent to which a participant sees life as being under his/her personal control vs. something that is fatalistically ruled. Scores range from 7 to 28, with higher scores indicating greater levels of mastery
Outcome measures
| Measure |
Peer Mentors
n=30 Participants
Mentors will attend one 6-7 hour virtual training session. Study expectations and logistics will be reviewed with each potential mentor prior to the training session via phone. Informed consent process will take place online via REDCap prior to the training session. Baseline data will be collected via online surveys. Next, mentors will receive training regarding topics including active listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on caregiver, practical approaches to symptom management, and caregiving issues. The study team will present the PERSEVERE curriculum and accompanying handbook. The team will solicit questions and lead roleplay conversations. Finally mentors will complete post-training assessments. Once all caregiver mentees (Arm 3) are recruited, the mentors will contact their mentees once weekly by phone for 16 weeks to deliver the PERSEVERE curriculum.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
Caregiver Mentees
n=28 Participants
Once Aim 2 is complete and mentors have been trained, caregiver mentees will be matched with mentors by relationship to LBD patient, then by sex and age, as much as possible. The study team will contact mentees once a match is available for them. The mentee will complete baseline primary and secondary outcome assessments online via REDCap, including: mastery and loneliness scales, Short Zarit Burden Interview, Hospital Anxiety and Depression Scale. The team will provide the mentor's contact information and send the PERSEVERE handbook. Mentoring pairs will begin the 16-week peer mentor program. Pairs will be expected to speak for \>15-30 minutes weekly, and to review that week's PERSEVERE topics in the handbook before or during each call to facilitate meaningful conversations. Mentors and mentees will complete online study diaries every 2 weeks. Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete postmentoring assessments online.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
|---|---|---|
|
Mastery Scale
Pearlin Mastery Score (mean) at baseline
|
21.65 units on a scale
Standard Deviation 3.09
|
18.91 units on a scale
Standard Deviation 2.90
|
|
Mastery Scale
Pearlin Mastery Score (mean) at week 16 of mentoring
|
22.13 units on a scale
Standard Deviation 3.47
|
19.2 units on a scale
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: pre- and post-mentoring intervention for mentees (16 weeks)Population: As pre-specified, this measure was only gathered in caregiver mentees. Neither focus group participants nor mentors answered this scale. Two of 30 mentees did not complete the 16-week visit, and therefore 28/30 mentees had data available at both baseline AND 16 weeks.
A 3-item, validated measurement of a participant's feelings of isolation or disconnectedness. Scores can range from 3-9, with higher scores indicating greater loneliness
Outcome measures
| Measure |
Peer Mentors
n=28 Participants
Mentors will attend one 6-7 hour virtual training session. Study expectations and logistics will be reviewed with each potential mentor prior to the training session via phone. Informed consent process will take place online via REDCap prior to the training session. Baseline data will be collected via online surveys. Next, mentors will receive training regarding topics including active listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on caregiver, practical approaches to symptom management, and caregiving issues. The study team will present the PERSEVERE curriculum and accompanying handbook. The team will solicit questions and lead roleplay conversations. Finally mentors will complete post-training assessments. Once all caregiver mentees (Arm 3) are recruited, the mentors will contact their mentees once weekly by phone for 16 weeks to deliver the PERSEVERE curriculum.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
Caregiver Mentees
Once Aim 2 is complete and mentors have been trained, caregiver mentees will be matched with mentors by relationship to LBD patient, then by sex and age, as much as possible. The study team will contact mentees once a match is available for them. The mentee will complete baseline primary and secondary outcome assessments online via REDCap, including: mastery and loneliness scales, Short Zarit Burden Interview, Hospital Anxiety and Depression Scale. The team will provide the mentor's contact information and send the PERSEVERE handbook. Mentoring pairs will begin the 16-week peer mentor program. Pairs will be expected to speak for \>15-30 minutes weekly, and to review that week's PERSEVERE topics in the handbook before or during each call to facilitate meaningful conversations. Mentors and mentees will complete online study diaries every 2 weeks. Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete postmentoring assessments online.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
|---|---|---|
|
Loneliness Scale
Baseline
|
5.64 units on a scale
Standard Deviation 1.99
|
—
|
|
Loneliness Scale
16 weeks (post-intervention)
|
5.71 units on a scale
Standard Deviation 2.16
|
—
|
SECONDARY outcome
Timeframe: pre- and post-mentoring intervention for mentees (16 weeks)Population: As pre-specified, this measure was only gathered in caregiver mentees. Neither focus group participants nor mentors answered this scale. Two of 30 mentees did not complete the 16-week visit, and therefore 28/30 mentees had data available at both baseline AND 16 weeks.
A 12-item, validated measurement of caregiver burden in older adults. Scores range from 0-48, with higher scores indicating greater caregiver burden
Outcome measures
| Measure |
Peer Mentors
n=28 Participants
Mentors will attend one 6-7 hour virtual training session. Study expectations and logistics will be reviewed with each potential mentor prior to the training session via phone. Informed consent process will take place online via REDCap prior to the training session. Baseline data will be collected via online surveys. Next, mentors will receive training regarding topics including active listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on caregiver, practical approaches to symptom management, and caregiving issues. The study team will present the PERSEVERE curriculum and accompanying handbook. The team will solicit questions and lead roleplay conversations. Finally mentors will complete post-training assessments. Once all caregiver mentees (Arm 3) are recruited, the mentors will contact their mentees once weekly by phone for 16 weeks to deliver the PERSEVERE curriculum.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
Caregiver Mentees
Once Aim 2 is complete and mentors have been trained, caregiver mentees will be matched with mentors by relationship to LBD patient, then by sex and age, as much as possible. The study team will contact mentees once a match is available for them. The mentee will complete baseline primary and secondary outcome assessments online via REDCap, including: mastery and loneliness scales, Short Zarit Burden Interview, Hospital Anxiety and Depression Scale. The team will provide the mentor's contact information and send the PERSEVERE handbook. Mentoring pairs will begin the 16-week peer mentor program. Pairs will be expected to speak for \>15-30 minutes weekly, and to review that week's PERSEVERE topics in the handbook before or during each call to facilitate meaningful conversations. Mentors and mentees will complete online study diaries every 2 weeks. Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete postmentoring assessments online.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
|---|---|---|
|
Short Zarit Burden Interview (ZBI-12)
Baseline
|
23.18 score on a scale
Standard Deviation 8.25
|
—
|
|
Short Zarit Burden Interview (ZBI-12)
Week 16 (post-intervention)
|
22.18 score on a scale
Standard Deviation 8.52
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: As pre-specified, we analyzed only caregiver mentee participants.
Anxiety subscale of the Hospital Anxiety and Depression Scale, where seven items measure anxiety. Total possible subscale range 0-21, where higher scores indicate worse outcome/more anxiety. A score \>8 on the subscale indicates probable symptoms
Outcome measures
| Measure |
Peer Mentors
n=28 Participants
Mentors will attend one 6-7 hour virtual training session. Study expectations and logistics will be reviewed with each potential mentor prior to the training session via phone. Informed consent process will take place online via REDCap prior to the training session. Baseline data will be collected via online surveys. Next, mentors will receive training regarding topics including active listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on caregiver, practical approaches to symptom management, and caregiving issues. The study team will present the PERSEVERE curriculum and accompanying handbook. The team will solicit questions and lead roleplay conversations. Finally mentors will complete post-training assessments. Once all caregiver mentees (Arm 3) are recruited, the mentors will contact their mentees once weekly by phone for 16 weeks to deliver the PERSEVERE curriculum.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
Caregiver Mentees
Once Aim 2 is complete and mentors have been trained, caregiver mentees will be matched with mentors by relationship to LBD patient, then by sex and age, as much as possible. The study team will contact mentees once a match is available for them. The mentee will complete baseline primary and secondary outcome assessments online via REDCap, including: mastery and loneliness scales, Short Zarit Burden Interview, Hospital Anxiety and Depression Scale. The team will provide the mentor's contact information and send the PERSEVERE handbook. Mentoring pairs will begin the 16-week peer mentor program. Pairs will be expected to speak for \>15-30 minutes weekly, and to review that week's PERSEVERE topics in the handbook before or during each call to facilitate meaningful conversations. Mentors and mentees will complete online study diaries every 2 weeks. Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete postmentoring assessments online.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) - Anxiety Score
Baseline
|
9.5 score on a scale
Standard Deviation 4.18
|
—
|
|
Hospital Anxiety and Depression Scale (HADS) - Anxiety Score
16 weeks
|
8.79 score on a scale
Standard Deviation 3.78
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: As pre-specified, we gathered and analyzed this outcome in caregiver mentees only. 28/30 mentees completed both baseline and 16-week assessments.
Brief, 15-item, highly validated scale for measuring depression in older adults, total possible range of 0-15, where a score \>5 suggests depression
Outcome measures
| Measure |
Peer Mentors
n=28 Participants
Mentors will attend one 6-7 hour virtual training session. Study expectations and logistics will be reviewed with each potential mentor prior to the training session via phone. Informed consent process will take place online via REDCap prior to the training session. Baseline data will be collected via online surveys. Next, mentors will receive training regarding topics including active listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on caregiver, practical approaches to symptom management, and caregiving issues. The study team will present the PERSEVERE curriculum and accompanying handbook. The team will solicit questions and lead roleplay conversations. Finally mentors will complete post-training assessments. Once all caregiver mentees (Arm 3) are recruited, the mentors will contact their mentees once weekly by phone for 16 weeks to deliver the PERSEVERE curriculum.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
Caregiver Mentees
Once Aim 2 is complete and mentors have been trained, caregiver mentees will be matched with mentors by relationship to LBD patient, then by sex and age, as much as possible. The study team will contact mentees once a match is available for them. The mentee will complete baseline primary and secondary outcome assessments online via REDCap, including: mastery and loneliness scales, Short Zarit Burden Interview, Hospital Anxiety and Depression Scale. The team will provide the mentor's contact information and send the PERSEVERE handbook. Mentoring pairs will begin the 16-week peer mentor program. Pairs will be expected to speak for \>15-30 minutes weekly, and to review that week's PERSEVERE topics in the handbook before or during each call to facilitate meaningful conversations. Mentors and mentees will complete online study diaries every 2 weeks. Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete postmentoring assessments online.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
|---|---|---|
|
Geriatric Depression Scale - Short Form (GDS-SF)
Baseline
|
5.0 score on a scale
Standard Deviation 3.76
|
—
|
|
Geriatric Depression Scale - Short Form (GDS-SF)
16 weeks
|
4.22 score on a scale
Standard Deviation 3.19
|
—
|
SECONDARY outcome
Timeframe: pre- and post-mentoring intervention for mentees (16 weeks)Population: This outcome was not assessed in the focus group arm, as pre-specified.
A validated, 20-item scale measuring participants' attitudes toward dementia and individuals with dementia. Scores can range from 7-140, with higher scores indicating more positive attitudes
Outcome measures
| Measure |
Peer Mentors
n=30 Participants
Mentors will attend one 6-7 hour virtual training session. Study expectations and logistics will be reviewed with each potential mentor prior to the training session via phone. Informed consent process will take place online via REDCap prior to the training session. Baseline data will be collected via online surveys. Next, mentors will receive training regarding topics including active listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on caregiver, practical approaches to symptom management, and caregiving issues. The study team will present the PERSEVERE curriculum and accompanying handbook. The team will solicit questions and lead roleplay conversations. Finally mentors will complete post-training assessments. Once all caregiver mentees (Arm 3) are recruited, the mentors will contact their mentees once weekly by phone for 16 weeks to deliver the PERSEVERE curriculum.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
Caregiver Mentees
n=28 Participants
Once Aim 2 is complete and mentors have been trained, caregiver mentees will be matched with mentors by relationship to LBD patient, then by sex and age, as much as possible. The study team will contact mentees once a match is available for them. The mentee will complete baseline primary and secondary outcome assessments online via REDCap, including: mastery and loneliness scales, Short Zarit Burden Interview, Hospital Anxiety and Depression Scale. The team will provide the mentor's contact information and send the PERSEVERE handbook. Mentoring pairs will begin the 16-week peer mentor program. Pairs will be expected to speak for \>15-30 minutes weekly, and to review that week's PERSEVERE topics in the handbook before or during each call to facilitate meaningful conversations. Mentors and mentees will complete online study diaries every 2 weeks. Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete postmentoring assessments online.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
|---|---|---|
|
Dementia Attitudes Scale (DAS)
Baseline
|
120.97 score on a scale
Standard Deviation 11.76
|
104.25 score on a scale
Standard Deviation 13.58
|
|
Dementia Attitudes Scale (DAS)
16 weeks (post-intervention)
|
121.60 score on a scale
Standard Deviation 11.81
|
111.57 score on a scale
Standard Deviation 9.38
|
SECONDARY outcome
Timeframe: Assessed at weeks 2, 4, 6, 8, 10, 12, 14, 16; average value calculated at week 16Population: As pre-specified, only mentees' reported call duration was analyzed. 28/30 mentees completed the intervention and week 16 surveys.
Online structured survey of mentoring phone call duration, in minutes
Outcome measures
| Measure |
Peer Mentors
n=28 Participants
Mentors will attend one 6-7 hour virtual training session. Study expectations and logistics will be reviewed with each potential mentor prior to the training session via phone. Informed consent process will take place online via REDCap prior to the training session. Baseline data will be collected via online surveys. Next, mentors will receive training regarding topics including active listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on caregiver, practical approaches to symptom management, and caregiving issues. The study team will present the PERSEVERE curriculum and accompanying handbook. The team will solicit questions and lead roleplay conversations. Finally mentors will complete post-training assessments. Once all caregiver mentees (Arm 3) are recruited, the mentors will contact their mentees once weekly by phone for 16 weeks to deliver the PERSEVERE curriculum.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
Caregiver Mentees
Once Aim 2 is complete and mentors have been trained, caregiver mentees will be matched with mentors by relationship to LBD patient, then by sex and age, as much as possible. The study team will contact mentees once a match is available for them. The mentee will complete baseline primary and secondary outcome assessments online via REDCap, including: mastery and loneliness scales, Short Zarit Burden Interview, Hospital Anxiety and Depression Scale. The team will provide the mentor's contact information and send the PERSEVERE handbook. Mentoring pairs will begin the 16-week peer mentor program. Pairs will be expected to speak for \>15-30 minutes weekly, and to review that week's PERSEVERE topics in the handbook before or during each call to facilitate meaningful conversations. Mentors and mentees will complete online study diaries every 2 weeks. Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete postmentoring assessments online.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
|---|---|---|
|
Duration of Mentoring Calls
|
45.04 minutes
Interval 12.0 to 138.75
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: As pre-specified, only caregiver mentees completed this measure at baseline and 16 weeks, with 28 total mentees completing the measure at both time points.
Depression subscale of the Hospital Anxiety and Depression Scale, where seven items measure depression. Total possible subscale range 0-21, where higher scores indicate worse outcome/more depression. A score \>8 on the subscale indicates probable symptoms
Outcome measures
| Measure |
Peer Mentors
n=28 Participants
Mentors will attend one 6-7 hour virtual training session. Study expectations and logistics will be reviewed with each potential mentor prior to the training session via phone. Informed consent process will take place online via REDCap prior to the training session. Baseline data will be collected via online surveys. Next, mentors will receive training regarding topics including active listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on caregiver, practical approaches to symptom management, and caregiving issues. The study team will present the PERSEVERE curriculum and accompanying handbook. The team will solicit questions and lead roleplay conversations. Finally mentors will complete post-training assessments. Once all caregiver mentees (Arm 3) are recruited, the mentors will contact their mentees once weekly by phone for 16 weeks to deliver the PERSEVERE curriculum.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
Caregiver Mentees
Once Aim 2 is complete and mentors have been trained, caregiver mentees will be matched with mentors by relationship to LBD patient, then by sex and age, as much as possible. The study team will contact mentees once a match is available for them. The mentee will complete baseline primary and secondary outcome assessments online via REDCap, including: mastery and loneliness scales, Short Zarit Burden Interview, Hospital Anxiety and Depression Scale. The team will provide the mentor's contact information and send the PERSEVERE handbook. Mentoring pairs will begin the 16-week peer mentor program. Pairs will be expected to speak for \>15-30 minutes weekly, and to review that week's PERSEVERE topics in the handbook before or during each call to facilitate meaningful conversations. Mentors and mentees will complete online study diaries every 2 weeks. Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete postmentoring assessments online.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale - Depression Score
Baseline
|
6.32 score on a scale
Standard Deviation 3.4
|
—
|
|
Hospital Anxiety and Depression Scale - Depression Score
16 weeks
|
5.61 score on a scale
Standard Deviation 3.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at 2, 4, 6, 8, 10, 12, 14, and 16 weeks; summed total phone calls at week 16 reportedPopulation: As pre-specified, only caregiver mentees' responses were analyzed for call frequency.
Online structured survey of number of calls
Outcome measures
| Measure |
Peer Mentors
n=28 Participants
Mentors will attend one 6-7 hour virtual training session. Study expectations and logistics will be reviewed with each potential mentor prior to the training session via phone. Informed consent process will take place online via REDCap prior to the training session. Baseline data will be collected via online surveys. Next, mentors will receive training regarding topics including active listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on caregiver, practical approaches to symptom management, and caregiving issues. The study team will present the PERSEVERE curriculum and accompanying handbook. The team will solicit questions and lead roleplay conversations. Finally mentors will complete post-training assessments. Once all caregiver mentees (Arm 3) are recruited, the mentors will contact their mentees once weekly by phone for 16 weeks to deliver the PERSEVERE curriculum.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
Caregiver Mentees
Once Aim 2 is complete and mentors have been trained, caregiver mentees will be matched with mentors by relationship to LBD patient, then by sex and age, as much as possible. The study team will contact mentees once a match is available for them. The mentee will complete baseline primary and secondary outcome assessments online via REDCap, including: mastery and loneliness scales, Short Zarit Burden Interview, Hospital Anxiety and Depression Scale. The team will provide the mentor's contact information and send the PERSEVERE handbook. Mentoring pairs will begin the 16-week peer mentor program. Pairs will be expected to speak for \>15-30 minutes weekly, and to review that week's PERSEVERE topics in the handbook before or during each call to facilitate meaningful conversations. Mentors and mentees will complete online study diaries every 2 weeks. Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete postmentoring assessments online.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
|---|---|---|
|
Frequency of Mentoring Calls
|
15 phone calls
Interval 5.0 to 19.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at 2, 4, 6, 8, 10, 12, 14, and 16 weeks; summed total missed phone calls at week 16 reportedPopulation: As pre-specified, we assessed and analyzed this variable in caregiver mentees only
Online structured survey of number of missed calls since last survey
Outcome measures
| Measure |
Peer Mentors
n=28 Participants
Mentors will attend one 6-7 hour virtual training session. Study expectations and logistics will be reviewed with each potential mentor prior to the training session via phone. Informed consent process will take place online via REDCap prior to the training session. Baseline data will be collected via online surveys. Next, mentors will receive training regarding topics including active listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on caregiver, practical approaches to symptom management, and caregiving issues. The study team will present the PERSEVERE curriculum and accompanying handbook. The team will solicit questions and lead roleplay conversations. Finally mentors will complete post-training assessments. Once all caregiver mentees (Arm 3) are recruited, the mentors will contact their mentees once weekly by phone for 16 weeks to deliver the PERSEVERE curriculum.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
Caregiver Mentees
Once Aim 2 is complete and mentors have been trained, caregiver mentees will be matched with mentors by relationship to LBD patient, then by sex and age, as much as possible. The study team will contact mentees once a match is available for them. The mentee will complete baseline primary and secondary outcome assessments online via REDCap, including: mastery and loneliness scales, Short Zarit Burden Interview, Hospital Anxiety and Depression Scale. The team will provide the mentor's contact information and send the PERSEVERE handbook. Mentoring pairs will begin the 16-week peer mentor program. Pairs will be expected to speak for \>15-30 minutes weekly, and to review that week's PERSEVERE topics in the handbook before or during each call to facilitate meaningful conversations. Mentors and mentees will complete online study diaries every 2 weeks. Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete postmentoring assessments online.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
|---|---|---|
|
Frequency of Missed Calls
|
1 phone calls
Interval 0.0 to 2.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Sixteen weeksPopulation: This outcome was not assessed in the focus group arm, as pre-specified.
Proportion of mentors and mentees, respectively, not completing study per protocol
Outcome measures
| Measure |
Peer Mentors
n=30 Participants
Mentors will attend one 6-7 hour virtual training session. Study expectations and logistics will be reviewed with each potential mentor prior to the training session via phone. Informed consent process will take place online via REDCap prior to the training session. Baseline data will be collected via online surveys. Next, mentors will receive training regarding topics including active listening, mentoring, goal-and boundary-setting, an overview of LBD, risk factors for hospitalization, impact on caregiver, practical approaches to symptom management, and caregiving issues. The study team will present the PERSEVERE curriculum and accompanying handbook. The team will solicit questions and lead roleplay conversations. Finally mentors will complete post-training assessments. Once all caregiver mentees (Arm 3) are recruited, the mentors will contact their mentees once weekly by phone for 16 weeks to deliver the PERSEVERE curriculum.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
Caregiver Mentees
n=30 Participants
Once Aim 2 is complete and mentors have been trained, caregiver mentees will be matched with mentors by relationship to LBD patient, then by sex and age, as much as possible. The study team will contact mentees once a match is available for them. The mentee will complete baseline primary and secondary outcome assessments online via REDCap, including: mastery and loneliness scales, Short Zarit Burden Interview, Hospital Anxiety and Depression Scale. The team will provide the mentor's contact information and send the PERSEVERE handbook. Mentoring pairs will begin the 16-week peer mentor program. Pairs will be expected to speak for \>15-30 minutes weekly, and to review that week's PERSEVERE topics in the handbook before or during each call to facilitate meaningful conversations. Mentors and mentees will complete online study diaries every 2 weeks. Upon completion of the 16-week mentor program, mentors and mentees will be sent a link to complete postmentoring assessments online.
Peer mentor support and caregiver intervention: Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
|
|---|---|---|
|
Dropout Rate of Mentors and Mentees, Respectively
|
0 Participants
|
2 Participants
|
Adverse Events
Focus Group Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peer Mentors
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caregiver Mentees
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place