Trial Outcomes & Findings for Efficacy Study of Kinto Care Coaching for Dementia Family Caregivers (NCT NCT05916664)
NCT ID: NCT05916664
Last Updated: 2025-03-05
Results Overview
Caregiver Mastery is a 9-item self-report questionnaire that assesses how competent individuals feel in their role as caregivers of individuals with dementia. Example items include I became more self-confident in providing care and I felt I was pretty good at figuring out what he/she needed. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating greater caregiver mastery. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater caregiver mastery.
COMPLETED
NA
495 participants
Changes in caregiver mastery between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).
2025-03-05
Participant Flow
Recruitment took place between 5/10/23 and 11/30/23. Recruitment and participation in the study occurred remotely.
Participant milestones
| Measure |
Intervention
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Overall Study
STARTED
|
249
|
246
|
|
Overall Study
COMPLETED
|
137
|
192
|
|
Overall Study
NOT COMPLETED
|
112
|
54
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy Study of Kinto Care Coaching for Dementia Family Caregivers
Baseline characteristics by cohort
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
Total
n=329 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.57 years
STANDARD_DEVIATION 12.27 • n=5 Participants
|
53.91 years
STANDARD_DEVIATION 13.24 • n=7 Participants
|
55.75 years
STANDARD_DEVIATION 13.04 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
24 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
111 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other / Missing
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
120 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
95 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
137 participants
n=5 Participants
|
192 participants
n=7 Participants
|
329 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Changes in caregiver mastery between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Caregiver Mastery is a 9-item self-report questionnaire that assesses how competent individuals feel in their role as caregivers of individuals with dementia. Example items include I became more self-confident in providing care and I felt I was pretty good at figuring out what he/she needed. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating greater caregiver mastery. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater caregiver mastery.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Caregiver Mastery
T1
|
2.80 score on a scale
Standard Deviation 0.43
|
2.80 score on a scale
Standard Deviation 0.47
|
|
Caregiver Mastery
T2
|
3.04 score on a scale
Standard Deviation 0.41
|
2.90 score on a scale
Standard Deviation 0.45
|
|
Caregiver Mastery
T3
|
3.07 score on a scale
Standard Deviation 0.45
|
2.92 score on a scale
Standard Deviation 0.43
|
PRIMARY outcome
Timeframe: Changes in emotional health strain between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Emotional Health Strain is a 4-item self-report questionnaire that assesses how emotionally strained individuals feel in their role as caregivers of individuals with dementia. Example items include I was under more stress, strain, or pressure and I was more nervous or bothered by nerves than before. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating more emotional health strain. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater emotional health strain.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Emotional Health Strain
T1
|
2.95 score on a scale
Standard Deviation 0.78
|
2.86 score on a scale
Standard Deviation 0.82
|
|
Emotional Health Strain
T2
|
2.46 score on a scale
Standard Deviation 0.85
|
2.64 score on a scale
Standard Deviation 0.81
|
|
Emotional Health Strain
T3
|
2.47 score on a scale
Standard Deviation 0.87
|
2.67 score on a scale
Standard Deviation 0.76
|
PRIMARY outcome
Timeframe: Changes in personal gain between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Personal Gain is a 4-item self-report questionnaire that assesses the personal gain experienced by individuals in their role as caregivers of individuals with dementia. Example items include Become more aware of your inner strengths and Become more self-confident. The measure is scored using a 4-point Likert scale (1=not at all to 4=a great deal) with higher scores indicating greater personal gain. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater personal gain.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Personal Gain
T1
|
2.56 score on a scale
Standard Deviation 0.84
|
2.53 score on a scale
Standard Deviation 0.77
|
|
Personal Gain
T2
|
2.73 score on a scale
Standard Deviation 0.84
|
2.54 score on a scale
Standard Deviation 0.77
|
|
Personal Gain
T3
|
2.77 score on a scale
Standard Deviation 0.82
|
2.55 score on a scale
Standard Deviation 0.80
|
PRIMARY outcome
Timeframe: Changes in financial self-efficacy between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Financial Self-Efficacy is a 10-item self-report questionnaire that assesses how efficacious individuals feel in their financial preparedness and skills for managing money as related to their caregiving role. Example items include I am confident that I will be able to successfully manage my loved one's finances and I feel confident in talking with my loved one about their finances. The measure is scored using a 4-point Likert scale (1=not at all to 4=a great deal) with higher scores indicating greater financial self-efficacy. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater financial self-efficacy.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Financial Self-Efficacy
T1
|
2.81 score on a scale
Standard Deviation 0.60
|
2.77 score on a scale
Standard Deviation 0.68
|
|
Financial Self-Efficacy
T2
|
3.08 score on a scale
Standard Deviation 0.63
|
2.87 score on a scale
Standard Deviation 0.69
|
|
Financial Self-Efficacy
T3
|
3.14 score on a scale
Standard Deviation 0.64
|
2.97 score on a scale
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: Changes in loneliness between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).The ULS-8 Loneliness Scale is an 11 item self-report questionnaire that assesses how lonely individuals feel with 8 original items and 3 additional items. Example items include I feel very close to one or more people and There are people who really understand me. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with lower scores indicating greater feelings of loneliness. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with lower scores indicating greater feelings of loneliness.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
ULS-8 Loneliness Scale
T1
|
2.89 score on a scale
Standard Deviation 0.51
|
2.86 score on a scale
Standard Deviation 0.52
|
|
ULS-8 Loneliness Scale
T2
|
2.97 score on a scale
Standard Deviation 0.50
|
2.84 score on a scale
Standard Deviation 0.52
|
|
ULS-8 Loneliness Scale
T3
|
2.96 score on a scale
Standard Deviation 0.49
|
2.86 score on a scale
Standard Deviation 0.58
|
PRIMARY outcome
Timeframe: Changes in perceived financial knowledge between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Perceived Financial Knowledge is a 1-item self-report questionnaire that assesses an individual's perceived knowledge about their financial preparedness and skills for managing money as related to their caregiving role. The item states Please rate your current understanding of how to manage money for you or the person you are caring for. The measure is scored using a 5-point Likert scale (1=no knowledge to 5=expert knowledge) with higher scores indicating greater perceived financial knowledge.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Perceived Financial Knowledge
T1
|
3.45 score on a scale
Standard Deviation 0.93
|
3.42 score on a scale
Standard Deviation 0.95
|
|
Perceived Financial Knowledge
T2
|
3.78 score on a scale
Standard Deviation 0.83
|
3.55 score on a scale
Standard Deviation 0.87
|
|
Perceived Financial Knowledge
T3
|
3.79 score on a scale
Standard Deviation 0.84
|
3.59 score on a scale
Standard Deviation 0.90
|
PRIMARY outcome
Timeframe: Changes in caregiver burden between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Caregiver Burden is a 4-item self-report questionnaire that assesses how much strain and stress individuals feel in their caregiving role for individuals with dementia. Example items include Do you feel that because of the time you spend with your relative that you don't have enough time for yourself and Do you feel stressed between caring for your relative and trying to meet other responsibilities (work/family)? The measure is scored using a 5-point Likert scale (1=never to 5=nearly always) with higher scores indicating greater caregiver burden. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 5, with higher scores indicating greater caregiver burden.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Caregiver Burden
T1
|
3.16 score on a scale
Standard Deviation 0.79
|
3.23 score on a scale
Standard Deviation 0.87
|
|
Caregiver Burden
T2
|
2.87 score on a scale
Standard Deviation 0.85
|
3.05 score on a scale
Standard Deviation 0.83
|
|
Caregiver Burden
T3
|
2.82 score on a scale
Standard Deviation 0.86
|
3.10 score on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Changes in relationship strain between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Dyadic Relationship Strain is a 7-item self-report questionnaire that assesses how strained individuals feel because of their caregiving relationship. Example items include I felt my relationship with him/her was strained and I felt resentful toward him/her. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating greater relationship strain. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater relationship strain.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Dyadic Relationship Strain
T1
|
2.22 score on a scale
Standard Deviation 0.74
|
2.21 score on a scale
Standard Deviation 0.70
|
|
Dyadic Relationship Strain
T2
|
1.98 score on a scale
Standard Deviation 0.72
|
2.08 score on a scale
Standard Deviation 0.66
|
|
Dyadic Relationship Strain
T3
|
2.00 score on a scale
Standard Deviation 0.74
|
2.13 score on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Changes in role captivity between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Role Captivity is a 3-item self-report questionnaire that assesses the extent to which individuals feel trapped in their role as a caregiver. Example items include I wished I were free to lead my own life and I felt trapped having to care for him/her. The measure is scored using a 4-point Likert scale (1=strongly disagree to 4=strongly agree) with higher scores indicating greater role captivity. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater role captivity.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Role Captivity
T1
|
2.46 score on a scale
Standard Deviation 0.86
|
2.41 score on a scale
Standard Deviation 0.83
|
|
Role Captivity
T2
|
2.23 score on a scale
Standard Deviation 0.84
|
2.38 score on a scale
Standard Deviation 0.85
|
|
Role Captivity
T3
|
2.17 score on a scale
Standard Deviation 0.84
|
2.38 score on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Changes in unmet needs between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Caregiver Unmet Needs is a 20-item self-report questionnaire that assesses unmet needs of caregivers. Example items include Do you need more information or help with understanding basic information about dementia? and Ideas to assist with your personal wellbeing as a caregiver? The measure is scored using dichotomous yes/no scoring (1=no/2=yes) with higher scores indicating more unmet needs. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 2, with higher scores indicating more unmet needs.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Caregiver Unmet Needs
T1
|
1.67 score on a scale
Standard Deviation 0.21
|
1.70 score on a scale
Standard Deviation 0.25
|
|
Caregiver Unmet Needs
T2
|
1.36 score on a scale
Standard Deviation 0.26
|
1.56 score on a scale
Standard Deviation 0.26
|
|
Caregiver Unmet Needs
T3
|
1.33 score on a scale
Standard Deviation 0.27
|
1.52 score on a scale
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Changes in unmet needs distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Caregiver Unmet Needs Distress is a 20-item self-report questionnaire that assesses the resulting distress due to caregiver unmet needs. Example items include How distressing or upsetting is understanding basic information about dementia? and Ideas to assist with your personal wellbeing as a caregiver? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress due to caregiver unmet needs. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress due to caregiver unmet needs.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Caregiver Unmet Needs Distress
T1
|
2.39 score on a scale
Standard Deviation 0.59
|
2.45 score on a scale
Standard Deviation 0.68
|
|
Caregiver Unmet Needs Distress
T2
|
1.86 score on a scale
Standard Deviation 0.57
|
2.29 score on a scale
Standard Deviation 0.69
|
|
Caregiver Unmet Needs Distress
T3
|
1.79 score on a scale
Standard Deviation 0.58
|
2.18 score on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Changes in anxiety symptoms between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Anxiety is a 7-item self-report questionnaire that assesses symptoms of anxiety. Example items include Feel nervous, anxious or on edge and Feel that you could not stop or control worrying? The measure is scored using a 4-point Likert scale (1=not at all to 4=nearly every day) with higher scores indicating more symptoms of anxiety. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more symptoms of anxiety.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Anxiety
T1
|
2.17 score on a scale
Standard Deviation 0.82
|
2.18 score on a scale
Standard Deviation 0.81
|
|
Anxiety
T2
|
1.92 score on a scale
Standard Deviation 0.85
|
2.06 score on a scale
Standard Deviation 0.79
|
|
Anxiety
T3
|
1.92 score on a scale
Standard Deviation 0.80
|
2.09 score on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Changes in depressive symptoms between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Depression is an 11-item self-report questionnaire that assesses symptoms of depression. Example items include Feel depressed and Feel that everything you did was an effort? The measure is scored using a 3-point Likert scale (1=hardly ever to 3=often) with higher scores indicating more symptoms of depression. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 3, with higher scores indicating more symptoms of depression.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Depression
T3
|
1.58 score on a scale
Standard Deviation 0.43
|
1.70 score on a scale
Standard Deviation 0.42
|
|
Depression
T1
|
1.68 score on a scale
Standard Deviation 0.44
|
1.73 score on a scale
Standard Deviation 0.44
|
|
Depression
T2
|
1.59 score on a scale
Standard Deviation 0.43
|
1.71 score on a scale
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: Changes in instrumental activities of daily living difficulty between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Instrumental and Personal Activities of Daily Living - Difficulty is a 16-item self-report questionnaire that assesses how much difficulty individuals with dementia experience in completing daily tasks as reported by their caregivers. Example items include How difficult was writing checks, paying bills, or balancing a checkbook? and Preparing a balanced meal? The measure is scored using a 4-point Likert scale (1=not difficult to 4=very difficult) with higher scores indicating more difficulty in completing instrumental activities. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more difficulty in completing instrumental activities.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Instrumental and Personal Activities of Daily Living - Difficulty
T1
|
2.48 score on a scale
Standard Deviation 0.82
|
2.44 score on a scale
Standard Deviation 0.87
|
|
Instrumental and Personal Activities of Daily Living - Difficulty
T2
|
2.49 score on a scale
Standard Deviation 0.85
|
2.39 score on a scale
Standard Deviation 0.82
|
|
Instrumental and Personal Activities of Daily Living - Difficulty
T3
|
2.55 score on a scale
Standard Deviation 0.88
|
2.45 score on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Changes in instrumental activities of daily living distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Instrumental Activities of Daily Living - Distress is a 16-item self-report questionnaire that assesses the resulting distress caregivers experience due to the amount of instrumental activities of daily living difficulty experienced by the individual they care for. Example items include How distressing or upsetting was this for you when the person you care performed these activities: Writing checks, paying bills, or balancing a checkbook? and Preparing a balanced meal? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Instrumental and Personal Activities of Daily Living - Distress
T1
|
2.08 score on a scale
Standard Deviation 0.73
|
2.10 score on a scale
Standard Deviation 0.83
|
|
Instrumental and Personal Activities of Daily Living - Distress
T2
|
1.95 score on a scale
Standard Deviation 0.83
|
2.04 score on a scale
Standard Deviation 0.72
|
|
Instrumental and Personal Activities of Daily Living - Distress
T3
|
1.93 score on a scale
Standard Deviation 0.79
|
2.07 score on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Changes in cognitive difficulty between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Cognition - Difficulty is an 8-item self-report questionnaire that assesses how much difficulty individuals with dementia experience with their cognition as reported by their caregivers. Example items include How difficult was remembering recent events? and Knowing what day of the week it is? The measure is scored using a 4-point Likert scale (1=not difficult to 4=very difficult) with higher scores indicating more cognitive difficulty. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more cognitive difficulty.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Cognition - Difficulty
T1
|
2.65 score on a scale
Standard Deviation 0.71
|
2.62 score on a scale
Standard Deviation 0.78
|
|
Cognition - Difficulty
T3
|
2.60 score on a scale
Standard Deviation 0.79
|
2.57 score on a scale
Standard Deviation 0.76
|
|
Cognition - Difficulty
T2
|
2.52 score on a scale
Standard Deviation 0.79
|
2.50 score on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Changes in cognitive distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Cognition - Distress is an 8-item self-report questionnaire that assesses the resulting distress caregivers experience due to the amount of cognitive difficulty experienced by the person they care for. Example items in reference to the person they are caring for include How distressing or upsetting was this for you: Remembering recent events? and Knowing what day of the week it is? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Cognition - Distress
T1
|
2.02 score on a scale
Standard Deviation 0.77
|
2.08 score on a scale
Standard Deviation 0.87
|
|
Cognition - Distress
T2
|
1.82 score on a scale
Standard Deviation 0.76
|
1.98 score on a scale
Standard Deviation 0.80
|
|
Cognition - Distress
T3
|
1.85 score on a scale
Standard Deviation 0.75
|
2.01 score on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Changes in behavioral frequency between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Behaviors - Frequency is a 14-item self-report questionnaire that assesses the frequency in which individuals with dementia experience dementia-related behaviors as reported by their caregivers. Example items include How often did the person you care for act confused? and Talk or mumble to himself/herself? The measure is scored using a 4-point Likert scale (1=none of the time to 4=most or all of the time ) with higher scores indicating more frequent behaviors. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating more frequent behaviors.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Behaviors - Frequency
T1
|
2.13 score on a scale
Standard Deviation 0.56
|
2.08 score on a scale
Standard Deviation 0.60
|
|
Behaviors - Frequency
T2
|
1.95 score on a scale
Standard Deviation 0.50
|
2.06 score on a scale
Standard Deviation 0.55
|
|
Behaviors - Frequency
T3
|
2.03 score on a scale
Standard Deviation 0.52
|
2.07 score on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Changes in behavioral distress between the control and intervention conditions will be evaluated across time from T1 (baseline) to T2 (post-intervention completion/6-weeks from baseline) and T3 (45 days from T2).Behaviors - Distress is a 14-item self-report questionnaire that assesses the resulting distress caregivers experience due to the behaviors of individuals with dementia. Example items in reference to the person they are caring for include How distressing or upsetting was this for you: Act confused? and Talk or mumble to himself/herself? The measure is scored using a 4-point Likert scale (1=not distressing to 4=very distressing) with higher scores indicating greater distress. The total score (reported in this study) is calculated as the average of the item scores, and ranges from 1 to 4, with higher scores indicating greater distress.
Outcome measures
| Measure |
Intervention
n=137 Participants
The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled.
Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app.
Kinto Care Coaching: Describe the basics of the intervention
|
Control
n=192 Participants
Control group that does not receive the Caregiver Support Intervention
|
|---|---|---|
|
Behaviors - Distress
T1
|
1.98 score on a scale
Standard Deviation 0.65
|
1.98 score on a scale
Standard Deviation 0.72
|
|
Behaviors - Distress
T2
|
1.73 score on a scale
Standard Deviation 0.57
|
1.92 score on a scale
Standard Deviation 0.62
|
|
Behaviors - Distress
T3
|
1.84 score on a scale
Standard Deviation 0.58
|
1.92 score on a scale
Standard Deviation 0.62
|
Adverse Events
Intervention
Control
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