Trial Outcomes & Findings for Stress and Hypertension in Dementia Caregivers (NCT NCT05721482)
NCT ID: NCT05721482
Last Updated: 2025-09-17
Results Overview
Change is being assessed in systolic blood pressure measured with an automatic blood pressure cuff. Results outside of the normal range (90/60 to 120/80 mmHg), both higher and lower are considered undesirable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Baseline, 3 months, 9 months
Results posted on
2025-09-17
Participant Flow
Participant milestones
| Measure |
MIM-DASH
A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.
Caregiver Training: A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.
The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.
|
Attention Control
A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stress and Hypertension in Dementia Caregivers
Baseline characteristics by cohort
| Measure |
MIM-DASH
n=14 Participants
A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.
Caregiver Training: A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.
The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.
|
Attention Control
n=14 Participants
A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
61.9 years
STANDARD_DEVIATION 7.52 • n=93 Participants
|
62.9 years
STANDARD_DEVIATION 8.67 • n=4 Participants
|
62.4 years
STANDARD_DEVIATION 7.98 • n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=93 Participants
|
14 participants
n=4 Participants
|
28 participants
n=27 Participants
|
|
Employment Status
Full-Time Employment
|
6 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Employment Status
Part-Time Employment
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Employment Status
Retired
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Employment Status
Not Employed
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Employment Status
Unknown/Not Reported
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 9 monthsChange is being assessed in systolic blood pressure measured with an automatic blood pressure cuff. Results outside of the normal range (90/60 to 120/80 mmHg), both higher and lower are considered undesirable.
Outcome measures
| Measure |
MIM-DASH
n=14 Participants
A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.
Caregiver Training: A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.
The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.
|
Attention Control
n=14 Participants
A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.
|
|---|---|---|
|
Change in Blood Pressure (Systolic)
Baseline
|
129 mmHg
Standard Deviation 18
|
127 mmHg
Standard Deviation 20
|
|
Change in Blood Pressure (Systolic)
3 month
|
122 mmHg
Standard Deviation 16
|
124 mmHg
Standard Deviation 17
|
|
Change in Blood Pressure (Systolic)
9 month
|
132 mmHg
Standard Deviation 12
|
122 mmHg
Standard Deviation 17
|
PRIMARY outcome
Timeframe: Baseline, 3 month, 9 monthChange is being assessed in diastolic blood pressure measured with an automatic blood pressure cuff. Results outside of the normal range (90/60 to 120/80 mmHg), both higher and lower are considered undesirable.
Outcome measures
| Measure |
MIM-DASH
n=14 Participants
A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.
Caregiver Training: A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.
The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.
|
Attention Control
n=14 Participants
A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.
|
|---|---|---|
|
Change in Blood Pressure (Diastolic)
3 month
|
72 mmHg
Standard Deviation 10
|
76 mmHg
Standard Deviation 11
|
|
Change in Blood Pressure (Diastolic)
Baseline
|
77 mmHg
Standard Deviation 8
|
82 mmHg
Standard Deviation 11
|
|
Change in Blood Pressure (Diastolic)
9 month
|
80 mmHg
Standard Deviation 10
|
76 mmHg
Standard Deviation 8
|
PRIMARY outcome
Timeframe: Baseline, 3 month, 9 monthChange in heart rate is being assessed with an automatic blood pressure cuff. Results outside of the normal range (60 to 100 beats per minute), both higher and lower, are considered undesirable.
Outcome measures
| Measure |
MIM-DASH
n=14 Participants
A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.
Caregiver Training: A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.
The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.
|
Attention Control
n=14 Participants
A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.
|
|---|---|---|
|
Change in Heart Rate
Baseline
|
73 Beats per minute
Standard Deviation 15
|
71 Beats per minute
Standard Deviation 7
|
|
Change in Heart Rate
3 month
|
77 Beats per minute
Standard Deviation 12
|
71 Beats per minute
Standard Deviation 13
|
|
Change in Heart Rate
9 month
|
70 Beats per minute
Standard Deviation 10
|
73 Beats per minute
Standard Deviation 11
|
SECONDARY outcome
Timeframe: BaselineMeasure of health literacy. Scores range from 0-6 with lower scores indicating lower health literacy
Outcome measures
| Measure |
MIM-DASH
n=14 Participants
A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.
Caregiver Training: A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.
The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.
|
Attention Control
n=14 Participants
A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.
|
|---|---|---|
|
Newest Vital Sign
|
4.23 score on a scale
Standard Deviation 1.69
|
3.92 score on a scale
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 9 monthsA list of 13 statements such as "I am able to use muscle relaxation techniques to reduce any tension I experience" that is measured on a Likert scale. Scores range from 0 to 52 with higher scores indicating greater use of stress management strategies.
Outcome measures
| Measure |
MIM-DASH
n=14 Participants
A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.
Caregiver Training: A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.
The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.
|
Attention Control
n=14 Participants
A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.
|
|---|---|---|
|
Change is Being Assessed in Stress Management Practices Survey Part A
3 month
|
39.31 score on a scale
Standard Deviation 6.58
|
38.2 score on a scale
Standard Deviation 7.47
|
|
Change is Being Assessed in Stress Management Practices Survey Part A
9 mon th
|
35.93 score on a scale
Standard Deviation 8.76
|
35.92 score on a scale
Standard Deviation 6.26
|
|
Change is Being Assessed in Stress Management Practices Survey Part A
Baseline
|
34.54 score on a scale
Standard Deviation 9.13
|
40.46 score on a scale
Standard Deviation 7.11
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 9 monthsThe Perceived Stress Scale has 10-items one a Likert scale with a reference range of 0-30 regarding stress over the past month. Values are: 0 - Never, 1 - Almost Never, 2 - Sometimes, 3 - Fairly Often, 4 - Very Often The investigators will sum 10 items to create a composite score, ranging from 0 to 40. The higher score, the higher levels of perceived stress.
Outcome measures
| Measure |
MIM-DASH
n=14 Participants
A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.
Caregiver Training: A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.
The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.
|
Attention Control
n=14 Participants
A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.
|
|---|---|---|
|
Change is Being Assessed in Perceived Stress Scale (Caregiver Stress)
Baseline
|
14.93 score on a scale
Standard Deviation 7.27
|
14.57 score on a scale
Standard Deviation 6.36
|
|
Change is Being Assessed in Perceived Stress Scale (Caregiver Stress)
3 month
|
14.92 score on a scale
Standard Deviation 6.5
|
10.78 score on a scale
Standard Deviation 3.73
|
|
Change is Being Assessed in Perceived Stress Scale (Caregiver Stress)
9 month
|
12.57 score on a scale
Standard Deviation 7.85
|
10.75 score on a scale
Standard Deviation 5.82
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 9 monthsThe World Health Organization (WHO-5) is a short questionnaire consisting of five Likert scale statements of well-being over the past 2-weeks. Scores range from 0-25. Higher scores represent higher quality of life
Outcome measures
| Measure |
MIM-DASH
n=14 Participants
A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.
Caregiver Training: A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.
The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.
|
Attention Control
n=14 Participants
A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.
|
|---|---|---|
|
Change is Being Assessed in in World Health Organization Quality of Life (WHO-5 QOL)
Baseline
|
13.79 score on a scale
Standard Deviation 5.91
|
16.83 score on a scale
Standard Deviation 3.46
|
|
Change is Being Assessed in in World Health Organization Quality of Life (WHO-5 QOL)
3 month
|
13.83 score on a scale
Standard Deviation 5.13
|
17.67 score on a scale
Standard Deviation 2.65
|
|
Change is Being Assessed in in World Health Organization Quality of Life (WHO-5 QOL)
9 month
|
15.14 score on a scale
Standard Deviation 5.53
|
16.2 score on a scale
Standard Deviation 3.29
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 9 monthsGeneralized Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). The GAD-7 represents an anxiety measure based on seven items which are scored from zero to three. The whole scale score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively.
Outcome measures
| Measure |
MIM-DASH
n=14 Participants
A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.
Caregiver Training: A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.
The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.
|
Attention Control
n=14 Participants
A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.
|
|---|---|---|
|
Change is Being Assessed in Generalized Anxiety Symptom Scale
Baseline
|
5.64 score on a scale
Standard Deviation 4.07
|
3.29 score on a scale
Standard Deviation 2.89
|
|
Change is Being Assessed in Generalized Anxiety Symptom Scale
3 month
|
4.46 score on a scale
Standard Deviation 3.93
|
3.8 score on a scale
Standard Deviation 2.82
|
|
Change is Being Assessed in Generalized Anxiety Symptom Scale
9 month
|
3.5 score on a scale
Standard Deviation 3.7
|
2.33 score on a scale
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 9 monthsAssess psychological comorbidity of the caregiver and health status of the person living with ADRD. 32-item check-list that assess activities of daily living and problem behaviors in people living with Alzheimer's disease and related dementias (AD/ADRD). Scores range from 0-96 with higher indicating more behavioral problems in the care recipient
Outcome measures
| Measure |
MIM-DASH
n=14 Participants
A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.
Caregiver Training: A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.
The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.
|
Attention Control
n=14 Participants
A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.
|
|---|---|---|
|
Change is Being Assessed in Revised Memory and Behavior Checklist
Baseline
|
20.57 score on a scale
Standard Deviation 15.34
|
15.92 score on a scale
Standard Deviation 11.43
|
|
Change is Being Assessed in Revised Memory and Behavior Checklist
3 month
|
18.58 score on a scale
Standard Deviation 12.43
|
15.5 score on a scale
Standard Deviation 11.3
|
|
Change is Being Assessed in Revised Memory and Behavior Checklist
9 month
|
14 score on a scale
Standard Deviation 10.17
|
16.3 score on a scale
Standard Deviation 13.94
|
SECONDARY outcome
Timeframe: 3 monthsThe Credibility Scale measures attitudes towards the treatment condition and the participants' expectation of benefit once the treatment has been explained. The scale consists of 5 questions rated on a 0 (not at all confident) to 10 (very confident). The range of scores is from 0 - 50. Higher scores, up to 45, will indicate greater credibility of the treatment condition. There are no subscales in this tool.
Outcome measures
| Measure |
MIM-DASH
n=14 Participants
A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.
Caregiver Training: A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.
The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.
|
Attention Control
n=14 Participants
A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.
|
|---|---|---|
|
Credibility Scale
|
41.23 score on a scale
Standard Deviation 4.92
|
41.42 score on a scale
Standard Deviation 3.37
|
SECONDARY outcome
Timeframe: 3 monthsTreatment-specific preference ratings (pre- and post-intervention).The participants will complete the Acceptability of Participant Preferences 13-item Likert-type survey ranging from 1 (strongly disagree) to 5 (strongly agree). Scores can range from 13 - 65. Higher scores indicate that participants find the intervention more acceptable. There are no subscales in this tool.
Outcome measures
| Measure |
MIM-DASH
n=14 Participants
A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.
Caregiver Training: A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.
The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.
|
Attention Control
n=14 Participants
A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.
|
|---|---|---|
|
Acceptability Scale
|
59.08 score on a scale
Standard Deviation 7.38
|
60.83 score on a scale
Standard Deviation 5.56
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 9 monthsThe K-Wood-MAS-4 is a self-report 4-item, hybrid tool developed to capture four domains of adherence behavior: self-efficacy, physical function, intentional medication-taking, and forgetfulness. The 4-item scale categorizes participants as low and high adherence. Scores range from 0 to 4 with a score of 1 or greater indicating lower prescription medication adherence. There are no sub-scales in this tool.
Outcome measures
| Measure |
MIM-DASH
n=14 Participants
A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.
Caregiver Training: A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.
The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.
|
Attention Control
n=14 Participants
A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.
|
|---|---|---|
|
Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4)
Baseline
|
1.214 score on a scale
Standard Deviation 1.188
|
1.077 score on a scale
Standard Deviation 1.115
|
|
Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4)
3 month
|
1.167 score on a scale
Standard Deviation 1.267
|
1 score on a scale
Standard Deviation 1.247
|
|
Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4)
9 month
|
0.929 score on a scale
Standard Deviation 0.917
|
1.091 score on a scale
Standard Deviation 1.221
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 9 monthsThe PHQ-9 is a 9-item measure of depression and each item is scored on a scale of 0-3. The total ranges from 0-27 (scores of 5-9 are mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; and 20 severe depression). Higher scores indicate worse depression and worse outcomes. There are no subscales in this tool.
Outcome measures
| Measure |
MIM-DASH
n=14 Participants
A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth.
Caregiver Training: A trained MIM provider and dietitian will deliver the MIM DASH group intervention in eight weekly 1-hour sessions via telehealth. Participants will receive session materials so they can follow along. Each MIM session consists of material related to mindfulness-the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on sharing ideas toward effective practice and practical daily challenges to being mindful. Each class begins with a prompt for participant contemplation during the next hour that reference a unique weekly theme which will be reiterated in the session materials.
The DASH portion, led by the Registered Dietitian, focuses on education to increase vegetables, fruits, whole grains and decrease intakes of fat and sodium, sugar sweetened beverages and sweets. Education includes adapting traditional "Soul" food dishes to meet the DASH dietary guidelines.
|
Attention Control
n=14 Participants
A trained interventionist will deliver the Caregiver Training. Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use Alzheimer's Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, participants will receive educational materials so they can follow along using videoconferencing or phone.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
Baseline
|
4.86 score on a scale
Standard Deviation 3.61
|
3.69 score on a scale
Standard Deviation 2.72
|
|
Patient Health Questionnaire (PHQ-9)
3 month
|
6.23 score on a scale
Standard Deviation 4.82
|
3.9 score on a scale
Standard Deviation 2.47
|
|
Patient Health Questionnaire (PHQ-9)
9 month
|
3.62 score on a scale
Standard Deviation 3.36
|
3.42 score on a scale
Standard Deviation 2.35
|
Adverse Events
MIM-DASH
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control
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
Dr. Kathy Wright
The Ohio State University College of Nursing
Phone: 614-292-0309
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place