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Stress and Hypertension in Dementia Caregivers

Addressing the Double Jeopardy of Stress and Hypertension Among African American Female Caregivers of Persons Living With Alzheimer's Disease and Related Dementias

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05721482
Acronym
MIM-DASH
Enrollment
28
Registered
2023-02-10
Start date
2023-01-17
Completion date
2025-09-02
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Stress, Psychological

Keywords

Dementia Caregivers

Brief summary

No demographic group is more at risk for the double jeopardy of caregiving stress and hypertension (HTN) than African American women caring for a family member with Alzheimer's disease and related dementias (ADRD). Both situations lead to reduced quality of life and cardiovascular disease-a complication of uncontrolled hypertension. Maintaining the health of these caregivers is critical to support the well-being of the care recipients. Although some multi-component interventions have addressed ADRD caregiver's stress and quality of life, gaps remain in targeting interventions to address the complexity of chronic caregiving stress and hypertension self-care in African American women. This pilot study builds on the investigator's earlier work which showed that stress, blood pressure knowledge, and complex diet information deficits all interfered with older African American women's hypertension self-care. Lifestyle changes (stress management, reducing sodium, eating fruits/vegetables, and physical activity) are effective in managing hypertension. The investigator's Stage I pilot study is based on the scientific rationale that these lifestyle changes can be promoted by addressing stress reactivity/stress resilience, the psychological and physiological response of the body to stress, as the underlying mechanism to facilitate behavioral change. In this way the study can improve health outcomes (caregiver stress, quality of life, cardiovascular disease risk).

Detailed description

More than 60% of all informal Alzheimer's disease and related dementias caregiving costs are borne by African American women. Not only do these women face the known deleterious effects from caregiving stress, but also the deleterious effects from hypertension: reduced quality of life and longevity, disability, cognitive decline, and strokes. Indeed, the cumulative index of hypertension by age 55 is 75.7% for African American women compared to 40% for White women. Despite the prevalence of hypertension among African American women, to the investigator's knowledge, there are no interventions that target the complexity of chronic caregiving stress and hypertension self-care for African American women caregivers. The purpose of this pilot two-group randomized controlled pilot (N=28) is to determine the feasibility and acceptability of Mindfulness in Motion (MIM) plus the Dietary Approaches to Stop Hypertension (DASH) compared to an attention control group (Alzheimer's Association Care Training Resources) in African American caregivers with hypertension. MIM includes mindful awareness and movement from chair/standing positions, breathing exercises, healthy sleep, and guided mindfulness meditation. DASH (tailored for African Americans) uses a critical thinking approach that involves problem solving, participant-centered goal setting, health coaching, reflection, and development of self-efficacy (confidence) to promote physical activity and healthy eating. The attention control, Care Training consists of healthy living for participant's brain and body and effective communication. Randomized participants will receive the MIM DASH or Caregiver Training in 8 weekly 1-hour group sessions via telehealth. Both groups will receive bi-monthly coaching calls after completion of the 8-week intervention for 2-months. The central hypothesis is that by addressing caregiving stress reactivity/stress resilience, as the underlying mechanism to facilitate behavioral change, the intervention will also be successful in enhancing hypertension self-care. Study aims are to: (1) Determine the feasibility and acceptability of MIM DASH and Caregiver Training for African American women caregivers (age 40 and older) with hypertension; (2) Explore the impact of MIM DASH as compared to Caregiving Training control on caregiver stress (primary) and systolic blood pressure (secondary); and (3) Examine caregiver stress reactivity/stress resilience as the potential mechanism of action between the MIM DASH intervention and behavior change. Feasibility and acceptability data (e.g., screening to enrollment and treatment-specific preference ratings) will be collected throughout the study. Perceived stress, hair cortisol, stress resilience/stress reactivity, systolic blood pressure, self-care practice (stress management, nutrition, and physical activity) data are collected at baseline, 3-months, 3-months, and 9-months. This pilot will make a substantive contribution to the science of behavior change by identifying basic mechanisms, in the adoption of healthy behaviors, which can be used to implement self-care interventions to reduce health disparities in African Americans. Findings from the pilot study will inform the infrastructure for an R01 to the National Institutes on Aging.

Interventions

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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Randomized control trial of behavioral intervention

Eligibility

Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* diagnosis of Hypertension (HTN) treated with an antihypertensive medication; * age 40 and older * a caregiver rating of the People Living With Dementia (PLWD) of 2 or greater on the Alzheimer's Dementia-8 scale; * caregiver provides unpaid care to a PLWD at least 10 hours per week or assists with at least one instrumental activity of daily living * self-identifies as Black/African American; * English speaking; and * access to a telecommunications device such as the internet via desktop, laptop/tablet, smartphone, or telephone.

Exclusion criteria

* expect to move out of the area within 9 months; * diagnosis of resistant HTN (blood pressure that remains above goal despite concurrent use of a diuretic/water pill and at least two other antihypertensive agents of different classes); or * active participation in mindfulness/yoga program. The National Institute of Aging Common Data Screening and Enrollment forms will be used to track data.

Design outcomes

Primary

MeasureTime frameDescription
Change in Blood Pressure (Systolic)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.
Change in Blood Pressure (Diastolic)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.
Change in Heart RateBaseline, 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.

Secondary

MeasureTime frameDescription
Change is Being Assessed in in World Health Organization Quality of Life (WHO-5 QOL)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
Change is Being Assessed in Generalized Anxiety Symptom ScaleBaseline, 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.
Change is Being Assessed in Revised Memory and Behavior ChecklistBaseline, 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
Newest Vital SignBaselineMeasure of health literacy. Scores range from 0-6 with lower scores indicating lower health literacy
Acceptability Scale3 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.
Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4)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.
Patient Health Questionnaire (PHQ-9)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.
Credibility Scale3 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.
Change is Being Assessed in Stress Management Practices Survey Part ABaseline, 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.
Change is Being Assessed in Perceived Stress Scale (Caregiver Stress)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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
14
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.
14
Total28

Baseline characteristics

CharacteristicMIM-DASHTotalAttention Control
Age, Customized
Age
61.9 years
STANDARD_DEVIATION 7.52
62.4 years
STANDARD_DEVIATION 7.98
62.9 years
STANDARD_DEVIATION 8.67
Employment Status
Full-Time Employment
6 Participants16 Participants10 Participants
Employment Status
Not Employed
1 Participants1 Participants0 Participants
Employment Status
Part-Time Employment
1 Participants1 Participants0 Participants
Employment Status
Retired
5 Participants7 Participants2 Participants
Employment Status
Unknown/Not Reported
1 Participants3 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
12 Participants25 Participants13 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants3 Participants1 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
14 participants28 participants14 participants
Sex: Female, Male
Female
14 Participants28 Participants14 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 140 / 14
other
Total, other adverse events
0 / 140 / 14
serious
Total, serious adverse events
0 / 140 / 14

Outcome results

Primary

Change in Blood Pressure (Diastolic)

Change 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.

Time frame: Baseline, 3 month, 9 month

ArmMeasureGroupValue (MEAN)Dispersion
MIM-DASHChange in Blood Pressure (Diastolic)9 month80 mmHgStandard Deviation 10
MIM-DASHChange in Blood Pressure (Diastolic)Baseline77 mmHgStandard Deviation 8
MIM-DASHChange in Blood Pressure (Diastolic)3 month72 mmHgStandard Deviation 10
Attention ControlChange in Blood Pressure (Diastolic)9 month76 mmHgStandard Deviation 8
Attention ControlChange in Blood Pressure (Diastolic)Baseline82 mmHgStandard Deviation 11
Attention ControlChange in Blood Pressure (Diastolic)3 month76 mmHgStandard Deviation 11
Primary

Change in Blood Pressure (Systolic)

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.

Time frame: Baseline, 3 months, 9 months

ArmMeasureGroupValue (MEAN)Dispersion
MIM-DASHChange in Blood Pressure (Systolic)Baseline129 mmHgStandard Deviation 18
MIM-DASHChange in Blood Pressure (Systolic)3 month122 mmHgStandard Deviation 16
MIM-DASHChange in Blood Pressure (Systolic)9 month132 mmHgStandard Deviation 12
Attention ControlChange in Blood Pressure (Systolic)Baseline127 mmHgStandard Deviation 20
Attention ControlChange in Blood Pressure (Systolic)3 month124 mmHgStandard Deviation 17
Attention ControlChange in Blood Pressure (Systolic)9 month122 mmHgStandard Deviation 17
Primary

Change in Heart Rate

Change 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.

Time frame: Baseline, 3 month, 9 month

ArmMeasureGroupValue (MEAN)Dispersion
MIM-DASHChange in Heart RateBaseline73 Beats per minuteStandard Deviation 15
MIM-DASHChange in Heart Rate3 month77 Beats per minuteStandard Deviation 12
MIM-DASHChange in Heart Rate9 month70 Beats per minuteStandard Deviation 10
Attention ControlChange in Heart RateBaseline71 Beats per minuteStandard Deviation 7
Attention ControlChange in Heart Rate3 month71 Beats per minuteStandard Deviation 13
Attention ControlChange in Heart Rate9 month73 Beats per minuteStandard Deviation 11
Secondary

Acceptability Scale

Treatment-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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
MIM-DASHAcceptability Scale59.08 score on a scaleStandard Deviation 7.38
Attention ControlAcceptability Scale60.83 score on a scaleStandard Deviation 5.56
Secondary

Change is Being Assessed in Generalized Anxiety Symptom Scale

Generalized 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.

Time frame: Baseline, 3 months, 9 months

ArmMeasureGroupValue (MEAN)Dispersion
MIM-DASHChange is Being Assessed in Generalized Anxiety Symptom ScaleBaseline5.64 score on a scaleStandard Deviation 4.07
MIM-DASHChange is Being Assessed in Generalized Anxiety Symptom Scale3 month4.46 score on a scaleStandard Deviation 3.93
MIM-DASHChange is Being Assessed in Generalized Anxiety Symptom Scale9 month3.5 score on a scaleStandard Deviation 3.7
Attention ControlChange is Being Assessed in Generalized Anxiety Symptom ScaleBaseline3.29 score on a scaleStandard Deviation 2.89
Attention ControlChange is Being Assessed in Generalized Anxiety Symptom Scale3 month3.8 score on a scaleStandard Deviation 2.82
Attention ControlChange is Being Assessed in Generalized Anxiety Symptom Scale9 month2.33 score on a scaleStandard Deviation 2.06
Secondary

Change is Being Assessed in in World Health Organization Quality of Life (WHO-5 QOL)

The 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

Time frame: Baseline, 3 months, 9 months

ArmMeasureGroupValue (MEAN)Dispersion
MIM-DASHChange is Being Assessed in in World Health Organization Quality of Life (WHO-5 QOL)Baseline13.79 score on a scaleStandard Deviation 5.91
MIM-DASHChange is Being Assessed in in World Health Organization Quality of Life (WHO-5 QOL)3 month13.83 score on a scaleStandard Deviation 5.13
MIM-DASHChange is Being Assessed in in World Health Organization Quality of Life (WHO-5 QOL)9 month15.14 score on a scaleStandard Deviation 5.53
Attention ControlChange is Being Assessed in in World Health Organization Quality of Life (WHO-5 QOL)Baseline16.83 score on a scaleStandard Deviation 3.46
Attention ControlChange is Being Assessed in in World Health Organization Quality of Life (WHO-5 QOL)3 month17.67 score on a scaleStandard Deviation 2.65
Attention ControlChange is Being Assessed in in World Health Organization Quality of Life (WHO-5 QOL)9 month16.2 score on a scaleStandard Deviation 3.29
Secondary

Change is Being Assessed in Perceived Stress Scale (Caregiver Stress)

The 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.

Time frame: Baseline, 3 months, 9 months

ArmMeasureGroupValue (MEAN)Dispersion
MIM-DASHChange is Being Assessed in Perceived Stress Scale (Caregiver Stress)Baseline14.93 score on a scaleStandard Deviation 7.27
MIM-DASHChange is Being Assessed in Perceived Stress Scale (Caregiver Stress)3 month14.92 score on a scaleStandard Deviation 6.5
MIM-DASHChange is Being Assessed in Perceived Stress Scale (Caregiver Stress)9 month12.57 score on a scaleStandard Deviation 7.85
Attention ControlChange is Being Assessed in Perceived Stress Scale (Caregiver Stress)Baseline14.57 score on a scaleStandard Deviation 6.36
Attention ControlChange is Being Assessed in Perceived Stress Scale (Caregiver Stress)3 month10.78 score on a scaleStandard Deviation 3.73
Attention ControlChange is Being Assessed in Perceived Stress Scale (Caregiver Stress)9 month10.75 score on a scaleStandard Deviation 5.82
Secondary

Change is Being Assessed in Revised Memory and Behavior Checklist

Assess 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

Time frame: Baseline, 3 months, 9 months

ArmMeasureGroupValue (MEAN)Dispersion
MIM-DASHChange is Being Assessed in Revised Memory and Behavior ChecklistBaseline20.57 score on a scaleStandard Deviation 15.34
MIM-DASHChange is Being Assessed in Revised Memory and Behavior Checklist3 month18.58 score on a scaleStandard Deviation 12.43
MIM-DASHChange is Being Assessed in Revised Memory and Behavior Checklist9 month14 score on a scaleStandard Deviation 10.17
Attention ControlChange is Being Assessed in Revised Memory and Behavior ChecklistBaseline15.92 score on a scaleStandard Deviation 11.43
Attention ControlChange is Being Assessed in Revised Memory and Behavior Checklist3 month15.5 score on a scaleStandard Deviation 11.3
Attention ControlChange is Being Assessed in Revised Memory and Behavior Checklist9 month16.3 score on a scaleStandard Deviation 13.94
Secondary

Change is Being Assessed in Stress Management Practices Survey Part A

A 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.

Time frame: Baseline, 3 months, 9 months

ArmMeasureGroupValue (MEAN)Dispersion
MIM-DASHChange is Being Assessed in Stress Management Practices Survey Part ABaseline34.54 score on a scaleStandard Deviation 9.13
MIM-DASHChange is Being Assessed in Stress Management Practices Survey Part A3 month39.31 score on a scaleStandard Deviation 6.58
MIM-DASHChange is Being Assessed in Stress Management Practices Survey Part A9 mon th35.93 score on a scaleStandard Deviation 8.76
Attention ControlChange is Being Assessed in Stress Management Practices Survey Part ABaseline40.46 score on a scaleStandard Deviation 7.11
Attention ControlChange is Being Assessed in Stress Management Practices Survey Part A3 month38.2 score on a scaleStandard Deviation 7.47
Attention ControlChange is Being Assessed in Stress Management Practices Survey Part A9 mon th35.92 score on a scaleStandard Deviation 6.26
Secondary

Credibility Scale

The 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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
MIM-DASHCredibility Scale41.23 score on a scaleStandard Deviation 4.92
Attention ControlCredibility Scale41.42 score on a scaleStandard Deviation 3.37
Secondary

Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4)

The 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.

Time frame: Baseline, 3 months, 9 months

ArmMeasureGroupValue (MEAN)Dispersion
MIM-DASHKrousel-Wood Medication Adherence Scale (K-Wood-MAS-4)Baseline1.214 score on a scaleStandard Deviation 1.188
MIM-DASHKrousel-Wood Medication Adherence Scale (K-Wood-MAS-4)3 month1.167 score on a scaleStandard Deviation 1.267
MIM-DASHKrousel-Wood Medication Adherence Scale (K-Wood-MAS-4)9 month0.929 score on a scaleStandard Deviation 0.917
Attention ControlKrousel-Wood Medication Adherence Scale (K-Wood-MAS-4)Baseline1.077 score on a scaleStandard Deviation 1.115
Attention ControlKrousel-Wood Medication Adherence Scale (K-Wood-MAS-4)3 month1 score on a scaleStandard Deviation 1.247
Attention ControlKrousel-Wood Medication Adherence Scale (K-Wood-MAS-4)9 month1.091 score on a scaleStandard Deviation 1.221
Secondary

Newest Vital Sign

Measure of health literacy. Scores range from 0-6 with lower scores indicating lower health literacy

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
MIM-DASHNewest Vital Sign4.23 score on a scaleStandard Deviation 1.69
Attention ControlNewest Vital Sign3.92 score on a scaleStandard Deviation 1.71
Secondary

Patient Health Questionnaire (PHQ-9)

The 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.

Time frame: Baseline, 3 months, 9 months

ArmMeasureGroupValue (MEAN)Dispersion
MIM-DASHPatient Health Questionnaire (PHQ-9)Baseline4.86 score on a scaleStandard Deviation 3.61
MIM-DASHPatient Health Questionnaire (PHQ-9)3 month6.23 score on a scaleStandard Deviation 4.82
MIM-DASHPatient Health Questionnaire (PHQ-9)9 month3.62 score on a scaleStandard Deviation 3.36
Attention ControlPatient Health Questionnaire (PHQ-9)Baseline3.69 score on a scaleStandard Deviation 2.72
Attention ControlPatient Health Questionnaire (PHQ-9)3 month3.9 score on a scaleStandard Deviation 2.47
Attention ControlPatient Health Questionnaire (PHQ-9)9 month3.42 score on a scaleStandard Deviation 2.35

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026