Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms
Phase: NA
Conditions: Dementia
Sponsor: HealthPartners Institute

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MINDFULNESS-BASED DEMENTIA CARE PARTNER PROGRAM TO 
REDUCE DEPRESSIVE SYMPTOMS 
 
Principal Investigator: 
Leah R. Hanson, PhD 
Senior Research Investigator, Senior Director of Neuroscience Research 
HealthPartners Institute 
Supported by: 
The National Institute on Aging 
 
 Grant Number:  5U54AG063546-03 subaward 00001963 
IMPACT ID FY21_Pilot2_Hanson 
NCT05617300 
 
 
 
Version 1.3 
May 19, 2023 

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TABLE OF CONTENTS                  
 
 
 
 
 
 
 
 
 
 
 
    Page 
1.1  PRÉCIS ........................................................................................................................... 5 
Study Title ................................................................................................................... 5 
Objectives .................................................................................................................... 5 
Design and Outcomes ................................................................................................... 5 
Interventions and Duration ........................................................................................... 5 
Sample Size and Population.......................................................................................... 5 
1 
STUDY OBJECTIVES .................................................................................................. 6 
1.1 
Primary Objective ............................................................................................. 6 
1.2 
Secondary Objectives ........................................................................................ 6 
2 
BACKGROUND AND RATIONALE ........................................................................... 6 
2.1 
Background on Condition, Disease, or Other Primary Study Focus ..................... 6 
2.2 
Study Rationale................................................................................................. 6 
3 
STUDY DESIGN............................................................................................................ 7 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS ....................................... 11 
4.1 
Inclusion Criteria ............................................................................................ 11 
4.2 
Exclusion Criteria ........................................................................................... 11 
4.3 
Study Enrollment Procedures .......................................................................... 11 
5 
STUDY INTERVENTIONS......................................................................................... 12 
5.1 
Interventions, Administration, and Duration..................................................... 12 
5.2 
Handling of Study Interventions ...................................................................... 12 
5.3 
Concomitant Interventions............................................................................... 13 
5.3.1 Allowed Interventions ....................................................................... 13 
5.3.2 Required Interventions ...................................................................... 13 
5.3.3 Prohibited Interventions .................................................................... 13 
5.4 
Adherence Assessment.................................................................................... 13 
6 
STUDY PROCEDURESSTUDY PROCEDURES....................................................... 14 
6.1 
Schedule of Study Activities............................................................................ 14 
6.2 
Description of Evaluations .............................................................................. 15 

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6.2.1 Screening Evaluation ........................................................................ 15 
6.2.2 Enrollment, Baseline, and/or Randomization...................................... 15 
6.2.3 Follow-up Visits ............................................................................... 16 
6.2.4 Completion/Final Evaluation ............................................................. 16 
7 
SAFETY ASSESSMENTS ........................................................................................... 17 
7.1 
Specification of Safety Parameters................................................................... 17 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters
 
17 
7.3 
Adverse Events and Serious Adverse Events .................................................... 17 
7.3.1 Reporting Procedures ........................................................................ 18 
7.3.2 Follow-up for Adverse Events ........................................................... 19 
7.4 
Safety Monitoring ........................................................................................... 20 
8 
INTERVENTION DISCONTINUATION ................................................................... 20 
9 
STATISTICAL CONSIDERATIONS ......................................................................... 20 
9.1 
General Design Issues ..................................................................................... 20 
9.2 
Sample Size and Randomization ...................................................................... 21 
9.2.1 Treatment Assignment Procedures ..................................................... 22 
9.3 
Interim analyses and Stopping Rules................................................................ 22 
9.4 
Outcomes ....................................................................................................... 22 
9.4.1 Primary outcome............................................................................... 22 
9.4.2 Secondary outcomes ......................................................................... 22 
9.5 
Data Analyses ................................................................................................. 23 
10 DATA COLLECTION AND QUALITY ASSURANCE ............................................. 25 
10.1 
Data Collection Forms .................................................................................... 25 
10.2 
Data Management ........................................................................................... 25 
10.3 
Quality Assurance ........................................................................................... 26 
10.3.1  Training............................................................................................ 26 
10.3.2 Quality Control Committee ............................................................... 26 
10.3.3 Metrics ............................................................................................. 26 
10.3.4 Protocol Deviations........................................................................... 26 
10.3.5 Monitoring........................................................................................ 26 
11 PARTICIPANT RIGHTS AND CONFIDENTIALITY .............................................. 26 
11.1 
Institutional Review Board Review.................................................................. 26 
11.2 
Informed Consent Forms ................................................................................. 26 

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11.3 
Participant Confidentiality............................................................................... 29 
11.4 
Study Discontinuation ..................................................................................... 29 
12 ETHICAL CONSIDERATIONS ................................................................................. 29 
13 COMMITTEES ........................................................................................................... 29 
14 PUBLICATION OF RESEARCH FINDINGS ............................................................ 29 
15 REFERENCES ............................................................................................................ 30 
 
 
 
 
 
 
 

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1.1  PRÉCIS 
Study Title  
Mindfulness-Based Dementia Care Partner Program to Reduce Depressive Symptoms   
Objectives  
 1. To assess the feasibility, acceptability, and fidelity of implementation of the MBDC 
program 
2. To determine the feasibility of obtaining clinical outcome measures 
3. To assess the willingness of participants to share access to healthcare utilization 
records 
Design and Outcomes   
This study will use a stepped wedge incomplete design with random assignment to 
accommodate continuous enrollment of participants and a rolling schedule of existing 
MBDC courses. Course participation includes the voluntary sharing of information 
through answering questions related to burden and mood as part of an administrative data 
collected at four points as illustrated below: 
 
 
Interventions and Duration  
The Mindfulness-Based Dementia Care (MBDC) program is an adaptation of 
Mindfulness-Based Stress Reduction (MBSR) for CPs of people living with Alzheimer’s 
disease and related dementias. The web-based, group intervention consists of nine 
sessions including weekly two-hour classes and a half-day retreat. Participants learn from 
certified instructors how to incorporate mindfulness practices into day-to-day life to help 
cope with the challenges and stresses of dementia care. Courses currently are part of the 
memory clinic programs at all three of the pilot sites. Participants will be a part of the 
study for about 7 months including 8 weeks of intervention, a variable pre-intervention 
control period, and a 3-month follow-up period. 
Sample Size and Population  
130 adult CPs of people living with Alzheimer’s disease or related dementia will be 
recruited to enroll in the MBDC program. Recruitment will occur as part of standard of 
care in three specialty care memory clinics. Eight or more MBDC courses will be held 
over the course of one year. During registration, CPs will self-select two options for a 
preferred day and time to meet for the group class. CPs will be randomly assigned to one 
of the two preferred day/times to assess the feasibility of randomization in a full scale 
embedded pragmatic clinical trial. 

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1 
STUDY OBJECTIVES 
1.1 Primary Objective 
The primary aim of this study is to assess the feasibility, acceptability, and fidelity of 
implementation of the Mindfulness Based Dementia Care (MBDC) program.  
 
1.2 Secondary Objectives 
The second aim of this study is to determine the feasibility of obtaining clinical outcome 
measures. The third aim of this study is to explore the feasibility of obtaining online 
consent for research access to care partner (CP) and person living with dementia (PLWD) 
healthcare utilization records. 
 
2 
BACKGROUND AND RATIONALE  
2.1 Background on Condition, Disease, or Other Primary Study Focus 
More than 11 million people provide unpaid care for people living with dementia 
(PLWD) in the United States.1 While there are certain positive aspects of being a care 
partner (CP) and caregiving, coping with the PLWD’s progressive loss of memory and 
ability to function in daily life can be particularly challenging and stressful. The increased 
burden and chronic stress of caregiving can lead to increased risk of mental health issues, 
as well as physical health changes.2,3,4 Compared to non-CPs, CPs have been shown to 
have increased incidence of chronic conditions, including heart disease and hypertension, 
as well as higher utilization of healthcare services.2,5 CPs also experience high rates of 
anxiety and depression.6 Increased depressive symptoms are associated with higher CP 
healthcare utilization.7 In a recent meta-analysis, depression was prevalent in 34% and 
anxiety in 44% of CPs of PLWD.8 The odds of having depression were 1.5 times higher 
for females than males and 2.5 times higher for spousal CPs.8 
2.2 Study Rationale 
Mindfulness Based Stress Reduction (MBSR) is a group-based, standardized program 
that is both psychoeducation and skills-based, which uses mindfulness meditation 
practices to help people better cope with their emotions.9  MBSR has been studied as a 
complimentary therapy to reduce stress and manage symptoms in a wide range of 
conditions including chronic pain, fibromyalgia, cancer, anxiety and depression.10-12 
Mindfulness based interventions, including MBSR, have been shown to decrease 
symptoms of depression.13,14 MBSR is safe, with no reported adverse events. A recent 
review focused on the ability of mindfulness-based interventions to support caregivers of 
older adults, assessing depression, anxiety, burden, stress, and quality of life.15 Three 
randomized controlled trials, including a total of 135 CPs, demonstrated lower level of 
depressive symptoms in MBSR groups compared to active control groups.16-18 There was 
also some evidence for improvements in anxiety, stress, and overall wellbeing.19 
Importantly, MBSR has been tested with the intervention delivered to CPs by 
community-based instructors.16 Thus, MBSR has shown Stage III efficacy in the NIH 
Stage Model for Behavioral Intervention Development and readiness for Stage IV testing. 

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There are still several challenges to a full-scale study of MBSR in CPs of PLWD 
including phased enrollment of courses,20 its lack of dementia and CP specific education 
and support, and the unavailability of pragmatic clinical outcomes. The Presence Care 
Project (www.presencecareproject.com), a community-based non-profit organization, has 
developed a version of MBSR designed specifically for CPs of PLWD called 
Mindfulness Based Dementia Care.21 Mindfulness Based Dementia Care (MBDC) is an 
nine-week group program, which includes both formal and informal mindfulness 
practice, role play, and lectures, combined with dementia-specific education and CP peer 
support. MBDC is recognized as a Dementia Care Program on the Best Practice 
Caregiving website, a partnership between Benjamin Rose Institute on Aging and Family 
Caregiver Alliance. MBDC participants learn how to incorporate mindfulness practices 
into day-to-day life as a CP to help cope with the challenges and stresses of dementia 
care. CPs participating in MBDC make changes to their thinking, becoming more self-
aware and mindful. These behavior changes are thought to lead to an increased ability to 
cope with emotions as measured by decreased depressive symptoms and CP burden 
(Figure 1). 
Figure 1. Intervention Framework 
 
MBDC is currently being taught at memory care clinics in the United States by 
Presence Care certified instructors. The cost of conducting a MBDC course is 
estimated to be in the range of $3,000-$4,000, depending on the site. Healthcare 
systems have typically supported the cost of instruction through clinic operational 
funds or philanthropy.  
 
3 
STUDY DESIGN 
Design: The overall goal of this proposal is to test the feasibility of implementing MBDC 
to guide subsequent evaluation of effectiveness of the MBDC intervention in a full-scale 
embedded pragmatic clinical trial (ePCT). This study will use a stepped wedge 
incomplete design with random assignment to accommodate continuous enrollment of 
participants and a rolling schedule of initiating MBDC courses. We aim to examine the 
effects of MBDC on depressive symptoms and burden in CPs of PLWD. CPs will be 
referred to MBDC from three healthcare settings and surrounding community partners. 
MBDC program registration and collection of administrative data will occur via Presence 
Care’s web-based platform. MBDC courses will be taught in groups via web-based video 
calls by Presence Care certified instructors, including one by an African American 
trainee. Eight or more courses will be taught over 9 months. Upon registering, CPs will 
select two preferred days/times for class and will be randomized to one of them. 
Participants may not be assigned to the instructor at their memory clinic. With up to 15 
participants anticipated per course, a total of up to 130 CPs will be enrolled. 
Administrative data will be collected at the time of registration, prior to the MBDC 
course, immediately following the MBDC course, and 3 months later (Figure 4). The 

Page 8 of 32 
 
administrative data collected will be used as pragmatic outcomes in this study. 
Participants will be a part of the study for about 7 months including 8 weeks of 
intervention, a variable pre-intervention control period, and a 3-month follow-up period.  
We will request a waiver of informed consent for this study. We will also request a 
partial HIPAA waiver of authorization for use of electronic health record data for 
recruitment purposes.  The administrative data collected by Presence Care is not 
protected health information; no HIPAA authorization/waiver is required, but the data 
obtained by the research team from Presence Care for research purposes will be covered 
by a data use agreement.   
Study population: The study 
population consists of CPs of 
PLWD from three settings. 
Multiple strategies described 
below will be used to increase the 
diversity of CP participating in 
MBDC. 
Settings: The three healthcare settings that will refer CPs to MBDC in this pilot include:  
• the HealthPartners Center for Memory & Aging in St. Paul, MN;  
• the Ray Dolby Brain Health Center at California Pacific Medical Center, a Sutter 
Health affiliate in San Francisco, CA; and  
• the University of Michigan – Alzheimer’s Disease Research Center in Ann Arbor, 
MI.  
Challenges to conducting ePCTs in CPs include the lack of pragmatically available 
clinical outcomes and the complexity of collecting and harmonizing data across multiple, 
diverse healthcare systems. MBDC evaluation data is currently being collected at the 
three pilot sites in different ways.  To overcome these challenges, we will partner with 
Presence Care to develop and implement a permanent centralized process for MBDC 
class registration and administrative data collection on their website. This upgraded 
infrastructure will enable the collection of common administrative data, including 
questionnaires with clinical outcomes, for long-term use in evaluation of the program. 
Randomization scheme: At the time of enrollment (registration on the Presence Care 
site), a CP will be presented with several currently enrolling class options (multiple 
days/times of week) and asked to select two that work with their schedule. They will then 
be randomly enrolled in one of the two selected courses, allowing for randomization on 
the class level while still accommodating the participant’s schedule. If a CP declines the 
assigned MBDC course, they will be allowed to self-select a course or to withdraw. As 
randomization is planned for the full-scale ePCT, it is important to determine 
acceptability of this component of implementation. This is balanced with the health care 
settings needs to support care partners experiencing stress. 
Figure 4. Study Design 

Page 9 of 32 
 
Intervention Structure and 
Implementation Protocol: 
MBDC group sessions will be 
held virtually via web-based 
video calls. Presence Care 
certified instructors will facilitate 
the sessions according to the 
MBDC protocol. Nine sessions 
including 8 weekly classes (2 
hours each) and a retreat (4 hours) 
will cover several topics (Table 
1). The session taught by the 
African American instructor may 
include in-person group meetings 
in that community church setting. 
The core course content for each session will be recorded for individuals who are unable 
to attend the live session. In this pilot, a phone option for CP participation will also be 
made available. There is currently a group of MBDC graduate meeting weekly by phone. 
Many of the CPs participating prefer the phone interaction vs. video call. We will explore 
whether phone participation increases access for participants with lower socioeconomic 
status and describe any differences in the intervention fidelity.  
Instructors will reach out to CPs that miss class sessions with an email checking in and 
include a link to the recording. CPs will be asked to watch the session and send the 
instructor a summary about the content to make up the session. Instructors may withdraw 
CPs who miss more than 3 sessions. CPs will be mailed one chapter of the MBDC 
workbook for each class (Appendix 1). The CP workbook is currently available in 
English for in-person and virtual classes. Presence Care is currently in the process of 
updating the in-person Spanish MBDC workbook for the virtual class mode.  Upon 
completion of the course, participants will be offered the opportunity to participate in a 
variety of mindfulness maintenance activities, such as weekly, guided virtual group 
meetings of MBDC graduates. 
The Presence Care website will be upgraded to include a permanent infrastructure for 
centralized registration and administrative data collection. Data collection will be 
completed through Research Electronic Data Capture (REDCap) and will include clinical 
outcomes and program evaluation questionnaires. REDCap is a secure web-based system 
used for data collection and is compliant with federal regulations (21 CFR Part 11, 
FISMA, HIPAA, and GDPR). A Presence Care administrator will have access to the 
entire dataset and each instructor will have access to their participants’ data. A data use 
agreement between Presence Care and HealthPartners Institute will be executed for the 
research use of data. Through this agreement, the HealthPartners biostatistician will have 
access to a limited data set through the REDCap portal.  
Data sources, elements, and collection protocol: Table 2 details the data elements 
collected. The main data source for this project is the Presence Care administrative 
database. All CP and PLWD data will be entered by the CP either into the website or 
given verbally to HealthPartners research support staff over the phone. There will be no 
Table 1. MBDC Session Topics 
CLASS TOPIC 
1 
Introduction to Mindfulness-Based 
Dementia Care -and one another! 
2 
Attitudinal Foundations & Beginning 
Practice 
3 
Living Grief & Self-Compassion 
4 
Coming to Our Senses 
5 
Everyday Communication 
6 
Being with Difficulty 
7 
(Retreat) 
Deepening Practice -Day of Mindfulness  
8 
Caring for Yourself 
9 
Reflecting Backward & Practicing Forward  
  

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transfer of data from healthcare settings to Presence Care. All questionnaires will include 
the same items, with an addendum added to the third questionnaire, which will include 
course evaluation and a theoretical assessment of willingness to share healthcare 
utilization data. Our Aim 3 goal is to determine whether CPs will be willing to consent 
online to share their insurance information evaluate healthcare utilization in future 
studies. The question would be “In the future, we wish to study how the MBDC affects 
health care utilization. If we were to do so, would you be willing to provide your 
Medicare ID number to help us understand how this program affects your health? Please 
note that we are not asking you to provide this information now, nor are collecting your 
utilization data.” A second question will ask if they are a legally authorized individual for 
the PLWD, and if so, would they theoretically consent to also sharing the Medicare ID of 
that individual. We will not collect the Medicare ID number but ask theoretically if they 
would consider participating and offer the choices of “yes/no/I don’t know”. 
 
Table 2. Data elements collected.  All items will be a permanent part of Presence Care administrative 
data collection. 
Data Forms 
Time Point 
Collected 
Entered 
By 
Detailed Data Elements 
Class 
Registration 
Initial Registration 
CP  
 
Name, Address, Date of Birth, Phone Number, 
Referral Source, Race, Ethnicity, Language, 
Education, Length of Caregiving, Relationship to 
PLWD, Preferred Classes, Emergency Contact 
CP (about 
PLWD) 
Name, Type of Residence, Date of Birth, 
Dementia Diagnosis 
Questionnaire 
1,2, 3, 4 
Initial Registration 
(Q1), Week before 
MBDC (Q2), Week 
after MBDC (Q3), 
3 months after 
MBDC completion 
(Q4) 
CP 
Clinical Outcome Scales: Depressive Symptoms 
(CES-D-1022) and Caregiver Burden (6-item Zarit 
Burden Interview, ZBI-624) 
CP Behavior Change Measures (: Self-
Compassion (The State Self-Compassion Scale 
Short Form, SSCS-S)25 and Mindfulness (The 5-
Item Mindful Attention Awareness Scale – 
State)26 
Questionnaire 3 
only 
Week after MBDC 
CP 
Course Satisfaction 
Assessment of willingness to share healthcare 
claims for CP and PLWD 
Presence Care 
Throughout MDBC 
sessions 
Instructor 
Class assigned, dates of classes, attendance, mode 
of attendance, instructor name 
Automated 
Information 
Throughout MBDC 
sessions 
REDCap 
Date of Registration, Date of Questionnaires 
Completion, Mode of Registration and Collection 
of Data 
Post-
Implementation 
Data  
Following 
completion of all 
MBDC sessions 
Clinic 
Directors 
Healthcare Setting Stakeholder Interviews of 
Memory Clinic Directors 
 
Outcomes: To assess the feasibility, acceptability, and fidelity of implementation of the 
MBDC program, the Aim 1outcomes will include: number of CP participants contacted 

Page 11 of 32 
 
for recruitment, number of CP enrolled, missingness in the class registration materials, 
response rate to the four questionnaires, completeness of the administrative generated 
data, CP attendance and module completion rates. To determine the feasibility of 
obtaining clinical outcome measures, the Aim 2 outcomes will include response rates and 
completeness of data for Depressive Symptoms (CES-D-1022) and Caregiver Burden (6-
item Zarit Burden Interview, ZBI-624). To explore the feasibility of CP sharing access to 
healthcare utilization records, the Aim 3 outcome will include the number of CPs who are 
express willingness for theoretical use. 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 Inclusion Criteria  
During the online MBDC registration process, CPs will be asked yes/no questions to 
determine eligibility based on the inclusion/exclusion criteria. Branching logic within the 
survey will prompt messaging for those are ineligible and trigger an exit from the 
registration process.  In addition, instructors will confirm eligibility of CPs during the 
check-in calls. 
Participants must meet all the following inclusion criteria to participate in this study 
• 
Age ≥18 years 
• 
Self-identify as being an informal CP providing caregiving to a PLWD 
• 
Register for an MBDC course through the Presence Care Website 
4.2 Exclusion Criteria  
All candidates meeting any of the exclusion criteria at baseline will be excluded from 
study participation. 
• 
Previous participation in an MBDC program. 
• 
Does not speak and understand either English. 
4.3 Study Enrollment Procedures  
Recruitment: Each pilot site has an established Presence Care certified instructor with 3-
7 years of experience teaching MBDC to CPs referred by the memory clinic in their 
health system. In preparation for a future larger study, we will train one new MBDC 
instructor as part of this pilot. MBDC courses are ongoing, with systems in place at each 
site for referring CPs, and classes being held virtually due to the COVID-19 pandemic. . 
Participants will be referred from memory care clinics at each of the three aligned 
healthcare settings using flyers. Flyers are handed out by clinicians (physicians, advance-
practice providers, neuropsychologists) during clinic visits to those CPs they feel would 
benefit from the program.  Referrals using flyers at clinics may also occur during 
conversations with non-clinician staff (social work, Care Ecosystem). Flyers are posted 
on the clinic website and public spaces in the clinic. Partnerships with community-based 
programs surrounding the pilot sites are also in place including sharing MBDC flyers 
with local day programs and the Alzheimer’s Association. Interested CPs referred to the 
MBDC program will visit the Presence Care website to register using the centralized 
system. 

Page 12 of 32 
 
In addition to the current practices above, this pilot will use additional strategies to 
maximize the participation of diverse CPs in our communities. In addition, at 
HealthPartners, we will request a waiver of consent to identify PLWD through the 
electronic health record and healthcare claims data, and mail letters with MBDC flyers to 
families with over-sampling of non-white and Hispanic patients. The study team 
programmer will identify patients using ICD-10 diagnostic codes for dementia or mild 
cognitive impairment (F00-F03, G30-G31.9) documented at least two outpatient or 
inpatient encounters or if present on to the problem list (a list of diagnoses on a patient’s 
electronic health record dashboard) in the electronic health record. At HealthPartners, 
patients can opt out of use of their data for research. We will exclude patients from 
mailings who have declined permission for their medical records to be used in research. 
CPs interested in participating will be directed to visit the Presence Care website to 
register using the centralized system. 
Randomization scheme: As described above in Section 3, at the time of enrollment 
(registration on the Presence Care site), a CP will be presented with several currently 
enrolling class options (multiple days/times of week) and asked to select two that work 
with their schedule. They will then be randomly enrolled in one of the two selected 
courses, allowing for randomization on the class level while still accommodating the 
participant’s schedule.  
Consenting: Participation in the MBDC program will be completely voluntary.  We plan 
to seek a waiver of informed consent for all aspects of the study.  Please see section 11.2 
for details. 
 
5 
STUDY INTERVENTIONS  
5.1 Interventions, Administration, and Duration  
MBDC group sessions will be held virtually via web-based video calls with a phone 
option available. Presence Care certified instructors will facilitate the sessions and use the 
MBDC participant Workbook (Appendix 1). Nine sessions including 8 weekly classes (2 
hours each) and a half-day retreat (4 hours) will cover several topics (Table 1).  
The core course content for each session will be recorded for individuals who are unable 
to attend. As taught in the Presence Care certification, instructors will reach out to CPs 
that miss class sessions with an informal email including a link to the recording. CPs will 
be asked to watch the session and send the instructor a brief summary about the content 
in order to make up the session. CPs will be emailed one chapter of the MBDC workbook 
for each class (Appendix 1). The CP workbook is currently available in English for in-
person and virtual classes. Presence Care is currently in the process of updating the in-
person Spanish MBDC workbook for the virtual class mode.  Upon completion of the 
course, participants will be offered the opportunity to participate in a variety of 
mindfulness maintenance activities, such as weekly, guided virtual group meetings of 
MBDC graduates. 
5.2 Handling of Study Interventions  
Instructors are already trained and certified by Presence Care Project.  All instructors will 

Page 13 of 32 
 
use the MBDC participant workbook (Appendix 1). Class attendance will be recorded by 
instructors in the REDCap database.   
5.3 Concomitant Interventions 
5.3.1 Allowed Interventions 
Not Applicable 
5.3.2 Required Interventions  
Not Applicable 
5.3.3  Prohibited Interventions 
Previous participation in an MBDC program. 
5.4 Adherence Assessment  
Adherence to the intervention is defined as attendance of >75% of classes (or watching 
video makeup) for at least 6 of 9 sessions.  

Page 14 of 32 
 
6 
STUDY PROCEDURESSTUDY PROCEDURES 
6.1 
Schedule of Study Activities 
Assessment 
Registration 
(Q1) 
Randomization  
Instructor 
Check-In 
Pre-Course 
Survey (Q2)  
MBDC 
Course 
Post-Course 
Survey (Q3) 
Follow-Up 
Survey (Q4) 
Timing 
 
4 wk before 
course 
2-3 wk before 
course 
Sent 10 days 
before course 
  
Sent 3 days 
after course 
Sent 3 mo 
after course  
Inclusion/Exclusion Criteria 
Participation Questions on Website 
X 
 
X 
 
 
 
 
Course Registration (CP, contact 
info, referral source, demographics, 
caregiving info, PLWD info, preferred 
course times/dates) 
X 
 
 
 
 
 
 
Clinical Outcome Scales 
X 
  
  
 X 
  
X 
X 
CP Behavior Change Measures 
X 
  
  
 X 
  
 X 
X 
Assignment to Course (course 
information) 
 
X 
 
  
  
  
X 
Check-in with Instructor 
 
 
X 
 
 
 
 
Course Attendance 
 
 
 
 
X 
 
 
Course Satisfaction  
 
 
  
  
  
 X 
  
Assessment of Willingness to Share 
Healthcare Claims Access 
 
 
 
  
  
X 
  
REDCap Automated Data Collection 
(dates of registration, randomization, 
questionnaire completion, etc.) 
X 
X 
X 
X 
X 
X 
X 
Adverse Events  
X  
X 
X 
X 
X 
X 
X 

6.2 Description of Evaluations  
There are no research visits in this pragmatic trial.  Below we describe the administrative 
data collection occurring as part of course registration and follow-up.  
6.2.1 Screening Evaluation 
Registration 
Care partners referred using flyers that are interested in the MBDC program will be 
directed to register on the Presence Care website. The website will contain 
information about the MBDC course and what is expected for participation. It will 
also include screening questions regarding the inclusion/exclusion criteria. When CPs 
confirm their interest, they will be directed to answer questions regarding their 
demographics, contact information, referral source, caregiving information, PLWD 
information, and preferred course times/dates. Next, there will be questionnaires that 
include the clinical outcome scales and behavior change measures. 
In this pragmatic clinical trial, enrollment is considered the act of completing 
registration for MBDC on the Presence Care Website.  
There is a variable time period between CP registration and randomization. In this 
pilot, we also include a phone option for registration with a staff member. For this 
pilot, we will use a HealthPartners research staff member to speak with CPS and enter 
the information given to them verbally into the Presence Care website registration 
link. We will assess the use of these phone services to determine if this is mode is 
needed for the full scale ePCT. 
 
6.2.2 Enrollment, Baseline, and/or Randomization 
Randomization 
Four weeks before a course is scheduled to start, CPs will be randomized to attend 
one of the two indicated as preferred days/times. They will be contacted by email of 
their assignment or by phone if that was the mode of registration. If a CP declines the 
assigned MBDC course, they will be given the option to choose their preferred day 
and time.  We are assessing the feasibility of randomization and do not want to 
withhold the MBDC program from those for whom this is not feasible. 
Instructor Check-In 
About two or three weeks prior to the course initiation, instructors will contact 
participants for a brief phone call (approximately 15 min) to discuss the MBDC 
program. They will review the inclusion/exclusion criteria, ensure the program is a 
good fit, and confirm that the CP understands the time commitment involved. These 
check-ins are a normal part of teaching MBDC. 
Pre-Course Survey 
Ten days prior to course initiation, CPs will receive an email with a link to a 
questionnaire. There will be 3 automated reminders (every 3 days) if the survey is not 

Page 16 of 32 
 
completed. HealthPartners research staff will similarly call CPs who registered via 
phone to obtain that data. 
MBDC Course Participation  
CPs will participate virtually in the live MBDC courses. Each course consists of nine 
sessions including 8 weekly classes and a 4-hour retreat. An extended session, like a 
retreat, is a protocolized part of any Mindfulness-Based curriculum.  In our 
experience, attendance for this session is strong, and participant feedback is quite 
positive. Based upon stakeholder feedback, we have reduced the regular 8-hour 
retreat to a 4-hour session. During the pandemic, we found that the online version of 
this retreat is powerful in a different way than the in-person version.  MBDC offers a 
bridge between mindfulness practice and the dementia care exchange.  Participants 
find that they can practice in their own home, with their loved one present, and often 
intermittently interrupting.  During the sessions, care partners are encouraged to 
include any disruptions and challenges in everyday life and caregiving, and to 
practice right where they are, as they are with no special conditions needed. In this 
pilot, we will evaluate the retreat, reasons why not attended, and add a question about 
the retreat length to the course satisfaction survey.  We will be able to adapt through 
the phased implementation of the courses, to find the best length to meet the needs of 
care partners in preparation for the implementation of a full scale ePCT. 
6.2.3 Follow-up Visits 
Post-Course Survey (Q3) 
Three days after course completion, CPs will receive an email with a link to a 
questionnaire. This survey will include clinical outcome scales and behavior change 
measures in addition to course satisfaction questions and healthcare claims access 
questions. There will be 3 automated reminders (every 5 days) if the survey is not 
completed. Research assistants will call CPs who registered via phone to obtain the 
data. 
After the conclusion of all MBDC courses, the study team will conduct a one-hour 
interview with the director of the specialty clinic at each Memory Clinic Directors. 
Topics of conversation will include their perspectives on recruitment for MBDC in 
the clinic and opportunities for improving processes. 
6.2.4 Completion/Final Evaluation 
Follow-Up Survey (Q4) 
Three months after course completion, CPs will receive an email with a link to a 
questionnaire. In the survey, there will be a statement of implied consent prior to the 
clinical outcome scales and behavior change measures. There will be 3 automated 
reminders (every 5 days) if the survey is not completed. Staff will call CPs who 
registered via phone to obtain the data. 
 

Page 17 of 32 
 
7 
SAFETY ASSESSMENTS  
7.1 Specification of Safety Parameters 
This pragmatic study has limited data available for safety parameters. We will monitor 
depressive symptoms and caregiver burden measured as part of the administrative data. If 
significant increases are observed between registration and the pre-course questionnaire, 
we will discuss whether the delay period is detrimental to CPs. If significant increases are 
observed between the pre and post course surveys (the opposite results than we expect), 
we will discuss whether MBDC implemented in this manner is either not effective or 
doing harm and make changes. 
7.2 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
There is a small potential for increased stress as a part of participation in the MBDC 
program. There is a rare chance that instructors may encounter CPs with exhibiting 
concerning levels of stress or anxiety. Instructors will reach out to these individuals and 
document this as an AE in the REDCap database. As part of their teaching responsibility, 
instructors obtain emergency contact information and the address of CPs in the rare case 
it is needed during MBDC sessions. 
7.3 Adverse Events and Serious Adverse Events  
AE Definition: AE is any untoward or unfavorable medical occurrence in a human study 
participant, including any abnormal sign (e.g. abnormal physical exam or laboratory 
finding), symptom, or disease, temporally associated with the participants’ involvement 
in the research, whether or not considered related to participation in the research.  
SAE Definition: SAEs consist of any adverse event that results in death; is life 
threatening or places the participant at immediate risk of death from the event as it 
occurred; requires or prolongs hospitalization; causes persistent or significant disability 
or incapacity; results in congenital anomalies or birth defects; is another condition which 
investigators judge to represent significant hazards. 
Unanticipated Problem (UP) Definition: any incident, experience, or outcome that 
meets all the following criteria: 
• 
unexpected, in terms of nature, severity, or frequency, given (a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (b) the 
characteristics of the study population;  
• 
related or possibly related to participation in the research; 
• 
suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
AEs for this study include:  No AEs are expected. More than 150 CPs have completed 
the MBDC program with no reports of adverse events. There is a small potential for 
increased stress as a part of participation in the MBDC program.  
SAEs for this study include:  No SAE are expected. More than 150 CPs have completed 
the MBDC program with no reports of adverse events. 

Page 18 of 32 
 
Process for identifying AEs, SAEs, and UPs: AEs, SAEs and UPs related to 
participation in the MBDC program will be collected by the instructors and entered into 
the Presence Care website database (REDCap system) where CP participation, such as 
attendance is collected. Entry of AEs, SAEs, and UPs will trigger an alert to the PI who 
will evaluate (and investigate if necessary), then categorize its severity, expectedness, and 
potential relatedness. 
Reporting schedule:  
 All adverse events that are serious (SAE) and unexpected (i.e., have not been 
previously reported for the study’s intervention) will be reported to the IMPACT 
Collaboratory Regulatory and Data Team Leader (Dr. Julie Lima), NIA IMPACT 
Collaboratory PO (Dr. Partha Bhattacharyya), and the IMPACT Collaboratory 
Safety Officer within 48 hours of the study’s knowledge of SAE.  
• Only those adverse events that are serious (SAE), unexpected, and related to the 
intervention must also be reported to Advarra IRB.  Unexpected and unrelated 
SAEs will be reported to Advarra IRB on a case-by-case basis if requested by the 
IMPACT Collaboratory  Safety Officer or NIA IMPACT Collaboratory PO. 
 All deaths will be reported to IMPACT Collaboratory Regulatory and Data Team 
Leader (Dr. Julie Lima), NIA IMPACT Collaboratory PO (Dr. Partha 
Bhattacharyya), and the IMPACT Collaboratory  Safety Officer within 24 hours 
of study’s knowledge of death.  
• Advarra IRB does not require the specific reporting of death outside of the SAE 
reporting requirement above, but they will be notified on a case-by-case basis if 
requested by the IMPACT Collaboratory  Safety Officer or NIA IMPACT 
Collaboratory PO. 
 All unanticipated problems (UPs) will be reported to the IMPACT Collaboratory 
Regulatory and Data Team Leader (Dr. Julie Lima), Advarra IRB, NIA IMPACT 
Collaboratory PO (Dr. Partha Bhattacharyya), and the IMPACT Collaboratory  
Safety Officer within 48 hours of the study’s knowledge of the event. 
 The summaries of all previously reported unexpected and related SAEs, deaths, 
and UPs, as well as all other SAEs and AEs will be reported to IMPACT 
Collaboratory Regulatory and Data Team Lead (Dr. Julie Lima), Advarra IRB, 
NIA IMPACT Collaboratory PO (Dr. Partha Bhattacharyya), and the IMPACT 
Collaboratory  Safety Officer at a minimum every 6 months, or at a frequency 
requested by the IMPACT Collaboratory  Safety Officer or NIA IMPACT 
Collaboratory PO. 
7.3.1 Reporting Procedures 
All data and safety monitoring reporting will classify SAEs and AEs as to their severity, 
expectedness, and potential relatedness to the study intervention as per the definitions 
below:  
Severity  

Page 19 of 32 
 
• 
Mild: Awareness of signs or symptoms, but easily tolerated and are of minor 
irritant type causing no loss of time from normal activities. Symptoms do not 
require therapy or a medical evaluation; signs and symptoms are transient. 
• 
Moderate: Events introduce a low level of inconvenience or concern to the 
participant and may interfere with daily activities, but are usually improved by 
simple therapeutic measures; moderate experiences may cause some interference 
with functioning 
• 
Severe:  Events interrupt the participant’s normal daily activities and generally 
require systemic drug therapy or other treatment; they are usually incapacitating 
Expectedness  
• 
Unexpected - nature or severity of the event is not consistent with information 
about the condition under study or intervention in the protocol, consent form, 
product brochure, or investigator brochure. 
• 
Expected - event is known to be associated with the intervention or condition 
under study. 
Relatedness   
• 
Definitely Related:  The adverse event is clearly related to the investigational 
agent/procedure – i.e. an event that follows a reasonable temporal sequence from 
administration of the study intervention, follows a known or expected response 
pattern to the suspected intervention, that is confirmed by improvement on 
stopping and reappearance of the event on repeated exposure and that could not 
be reasonably explained by the known characteristics of the subject’s clinical 
state. 
• 
Possibly Related:  An adverse event that follows a reasonable temporal sequence 
from administration of the study intervention follows a known or expected 
response pattern to the suspected intervention, but that could readily have been 
produced by a number of other factors. 
• 
Not Related:  The adverse event is clearly not related to the investigational 
agent/procedure - i.e. another cause of the event is most plausible; and/or a 
clinically plausible temporal sequence is inconsistent with the onset of the event 
and the study intervention and/or a causal relationship is considered biologically 
implausible. 
7.3.2 Follow-up for Adverse Events 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to 
the attention of the instructor during MBDC program classes. Instructors will capture 
these events in the REDCap database and follow-up as needed with CP participants. 

Page 20 of 32 
 
7.4 Safety Monitoring 
A NIA-appointed Data and Safety Monitoring Officer will monitor this study. 
8 
INTERVENTION DISCONTINUATION  
MBDC instructors may recommend a CP discontinue the program if participants are 
unable to meet the time commitment or have had a change in caregiving status. Care 
partners may withdraw voluntarily from participation in the study at any time and for any 
reason. There will be no replacement of subjects who discontinue early in this pilot study. 
9 
STATISTICAL CONSIDERATIONS  
9.1 General Design Issues  
Design choice and rationale 
A stepped wedge trial design was chosen to ensure all participants had the opportunity to 
participate in the MBDC course. This trial design has each individual contribute control 
and intervention data, allowing for within participant comparisons. The stepped wedge 
trials also provides flexibility with rolling recruitment as opposed to the requirement to 
fill a class that starts on a particular date, which has been a barrier in other mindfulness 
trials.26 An adaptive randomization schematic was chosen to ensure that the classes fill up 
at a relatively similar rate, another pragmatic concern to consider before attempting a 
larger study. For the secondary aim, shorter versions of the validated scales used to assess 
efficacy were chosen to align with the pragmatic nature of this work, ensuring 
participants spend minimum amount of time possible providing clinical outcome data.  
 
Hypotheses and Outcomes 
 
This pilot study will determine if it is feasible to implement the MBDC program with 
fidelity for testing in a full-scale ePCT. The primary feasibility progression criteria will 
be assessed using the previously described measures of feasibility, acceptability, and 
fidelity. For the progression criteria to be met with no modifications, we will require 
>75% participants attend (or watch video makeup) for at least 6 of 9 sessions. If that 
number is between 50% and 75%, we would recommend the study progress, however we 
will make modifications to increase adherence. We also define progression criteria based 
on the diversity of recruitment within the pilot. If our participants are not representative 
of the PWLD population’s racial and ethnic demographics within each care system, we 
will recommend changes to the recruitment strategy to encourage a higher enrollment rate 
of CPs who represent these populations. If progression criteria are met, secondary 
feasibility measures including the completeness of the clinical outcomes will be used to 
help direct data collection approach in future trials.  
 
The efficacy hypothesis is that participation in the MBDC course programming will 
reduce depressive symptoms and burden while increasing self-compassion and 
mindfulness in CPs for PLWD. These outcomes will be measured using the following 
assessments: 

Page 21 of 32 
 
 
Clinical Outcome Scales for Efficacy: 
 
Center for Epidemiologic Studies Depression Scale (CES-D): The Center for 
Epidemiologic Studies Depression Scale measures self-reported symptoms associated 
with depression. It has been validated for dementia and multiple other diagnoses, and it is 
sensitive to differences between caregivers and non-caregivers.27 The 10-item version has 
been shown to retain the reliability and validity of the original 20-item scale in the elderly 
population.28  
 
Zarit Burden Inventory: The Zarit Burden Inventory is an interview that evaluates 
caregiver burden through a self-report measure. The survey scores are positively 
correlated with behavior problems in older adults and depression scores of caregivers.29 
The shorten version of this scale, the ZBI-6, demonstrated comparable discriminative and 
internal consistency as the original 12-item versions.30 
 
Clinical Outcomes for Behavior Change  
 
The State Self-Compassion Scale Short Form: To evaluate self-compassion, participants 
indicated how often they acted in the manner stated in each of the items on a scare of 1 
(almost never) to 5 (almost always). The survey evaluates self-kindness verses self-
judgement, common humanity verses isolation, and mindfulness versus over-
identification31.  
 
Mindful Attention Awareness Scale: This 5-item scale asks participations to indicate at 
what level they relate to specific experiences, aimed at measuring main characteristics of 
mindfulness.25 Higher scores represented elevated levels of mindfulness expression. 
9.2 Sample Size and Randomization 
Sample size rationale: The sample size is largely determined by the logistics of the pilot 
award funding and time period. We plan to enroll up to 130 in MBDC courses offered 
during the study timeframe (up to 15 CP/course). While this pilot is not formally powered 
for efficacy, we estimate that a sample size of 120 would allow detection of a 3-point 
change in CES-D-10 scores associated with the intervention, assuming a modest 
correlation of scores within course session (ICC = .10) and CES-D-10 score standard 
deviation of 4, with 80% power and a two-sided alpha of 0.05. The results from the pilot 
will be used to better inform power-calculations for a large ePCT specifically to provide 
an estimate of the ICC associated with course cluster as this parameter is key in 
determining a study’s power a-priori. Table 2 provides estimates of the current study’s 
expected effect size with a range of assumptions for ICC value (0 to 0.3) and average 
CES-D-10 scores for the control period (10 to 15), as well as estimates for a hypothetical 
ePCT with a sample size of 450 (30 courses, 15 per course) maintaining at least 80% 
power. 
 
 
 

Page 22 of 32 
 
 
Table 2A. Effect size estimates for pilot study and full ePCT with varying ICC 
ICC 
Effect Size: Difference in CES-D-10 change between 
control and intervention 
Pilot Study 
N = 120, Courses = 8 
Large ePCT 
N = 450, Courses = 30 
0 
2.68 
1.32 
0.1 
2.99 
1.49 
0.3 
2.86 
1.44 
 
9.2.1 Treatment Assignment Procedures 
At the time of MBDC enrollment (registration on the Presence Care site), a CP will 
be presented with several currently enrolling class options (multiple days/times of 
week) and asked to select two that work with their schedule. Approximately 4 weeks 
prior to the course start date, they will then be randomly enrolled in one of the two 
selected courses, allowing for randomization on the class level while still 
accommodating the participant’s schedule. An adaptive randomization schematic will 
be used to adjust the probability of class assignment based on CPs already enrolled in 
the trial. Since randomization is preferred in the full-scale ePCT, it is important to 
assess the feasibility of the acceptability of the random assignment in this pilot. Once 
a CP has registered for a MBDC course, there is variable delay period until there are 
enough people to fill the class. During this time, Presence Care will send regular 
emails updates to stay in contact. Once a class option is full, CPs will be notified, and 
the class will start. If a CP situation or schedule has changed and they decline the 
assigned course, they will have the option choose a preferred day and time so that we 
do not deny anyone access to this program. 
9.3 Interim analyses and Stopping Rules 
No interim analysis is planned as this is a one-year pilot study. There are no statistical 
rules that would suspend MBDC program enrollment. The Safety Officer and NIA may 
decide to stop this study based upon review of data provided by the statistician.  
9.4 Outcomes  
9.4.1 Primary outcome   
To assess the feasibility, acceptability, and fidelity of implementation of the MBDC 
program, primary outcomes will include: number of CP participants contacted for 
recruitment, number of CP enrolled, missingness in the class registration materials, 
response rate to the four questionnaires, completeness of the administrative generated 
data, CP attendance and module completion rates.  
9.4.2 Secondary outcomes   
To determine the feasibility of obtaining clinical outcome measures, secondary 
outcomes will include response rates and completeness of data for CED-D-10 and 
ZBI-6. To explore the feasibility of obtaining online consent for research access to CP 

Page 23 of 32 
 
healthcare utilization records, exploratory outcomes will include the number of CPs 
who agree and consent to research access included on Questionnaire 3.  
9.5 Data Analyses 
Aim 1- Primary Feasibly Analysis: To assess the feasibility, acceptability, and fidelity 
of implementation of the MBDC program we will beginning by measuring the absolute 
number of potential CPs contacted for recruitment and the number of those who complete 
the online course enrollment. The total number of mailed flyers will be counted.  Adding 
documentation of flyer distribution to the current clinic workflow is too large of a barrier 
for this pragmatic trial. An estimate of flyers distributed in the clinics will made by 
asking clinic directors for total numbers of flyers printed.  These will be used to calculate 
the overall rate of program registration as well as broken down by referral site. The 
feasibility of collecting patient provided data will be evaluated by quantifying the 
missingness in the class registration materials as well the response rate to the four 
questionnaires. The completeness of the administrative generated data, including date of 
enrollment, course section, and attendance, will also be quantified. Fidelity of the 
intervention will be assessed by describing CP attendance and module completion rates 
as recorded by Presence Care staff. Completion patterns will be summarized overall and 
stratified by patient demographics and study site. The fidelity of the make-up video 
module offerings as a substitute for in-class participation will be evaluated by comparing 
course outcomes between CPs who completed the course fully in-class and those who 
utilized the make-up modules. Any differences in intervention fidelity associated with CP 
demographics will be described and discussed. Table 3 gives an example of how counts 
will be utilized to describe the recruitment, enrollment, and adherence. The 3-month post-
intervention questionnaire will be sent to all CP participants and the response rate and 
patterns for CP with adequate follow-up time within the study timeframe will be 
described. We expect that 60% of participants will have at least 3-months to reply to 
these additional questionnaires before the final analytic data is aggregated. 
Table 3. 
 
Counts for 
feasibility 
Use in analysis 
Participants contacted 
N 
Total number of targeted mailings 
Estimate of clinic flyer distribution 
using print rates 
Participants who enroll and 
are randomized into MBDC 
course section 
a 
Recruitment rate: a/N 
Participants who start 
MBDC course 
b 
Participation rate: b/N, compare to a/N  
Participants who complete 
course (6/9 modules) 
c 
Completion rate: c/b, used as main 
progression criteria 
Overall successful enrollment rate: c/N  
Number who complete each 
module in real-time –  
k = 1, …, 9 
dk 
Module specific completion rate: dk/b 

Page 24 of 32 
 
Number who complete each 
module as a make-up 
session –  
k = 1, …, 9 
ek 
Module specific make-up completion 
rate: ek/b 
Compare to dk/b to assess fidelity of 
make-up offerings 
Number who complete each 
questionnaire – m = 1,2,3 
fm 
Questionnaire specific response rate:  
fm/a and/or fm/b if a ≠b 
 
Aim 2 - Secondary Feasibility and Efficacy Analyses: The completeness of the CED-
D-10 and ZBI-6 outcomes will be quantified by calculating the rate of CPs that respond 
to all items on each scale (CES-D-10: 10 items, ZBI-6: 6 items) at each assessment. The 
rate of completion for both scales will be presented overall and stratified by 
questionnaire, site, and by CP demographics. As the current study design results in a non-
uniform length of the control period, the weeks between Q1 and Q2 will be recorded and 
summarized for the sample to better understand how the design could scale to a larger 
ePCT. A preliminary efficacy analysis will utilize the total scores for the CES-D-10 
(range: 0 to 30) and ZBI-6 (range: 0 to 24) calculated for all completed questionnaires. 
Both outcomes will be summarized at each questionnaire timepoint using means and/or 
medians, as appropriate. Change over the control (Q2-Q1) and intervention (Q3-Q2) 
periods will be calculated for each CP and summarized for the sample. Descriptive 
summaries will be provided for responses from CP who complete the 3-month follow-up 
questionnaire (Q4) within the 12-month study timeframe and before the final analytic 
dataset is defined. These responses will not be used in any of the formal inferential 
analyses. 
 
Analysis will utilize linear mixed-models with random effects to account for clustering of 
data within MBDC course section as well as repeated measures within CPs to estimate 
the intervention effect on depressive symptoms and care-giver burden (Equation 1). In a 
scaled up ePCT, we expect the unit of randomization to continue to be course section, 
which is reflected in our choice of random effects. The model structure will be based on a 
standard ANCOVA used to evaluate change that adjusts for the pre-intervention 
measurement of the outcome variable with the post-intervention measurement as the 
model outcome. Each CP will contribute a pair of data points for the control period (Pre: 
Q1, Post: Q2) and intervention period (Pre: Q2, Post: Q3) which requires our random 
effects structure to account for repeated measurements within CPs. If there is no 
difference in change in efficacy outcomes, we expect Q2-Q1 = Q3-Q2. Each model will 
include covariates to adjust for possible confounding associated with CP demographics 
and CP history (age, race/ethnicity, socioeconomic measures, and length of caregiving). 
While the relative time of measurement is considered (pre/post) our analysis does not 
adjust for time over the course of the study, as we hypothesize any treatment effect would 
be time-agnostic within the year-long pilot study time frame. When an ePCT with a 
longer timeline is considered, this assumption will have to be revisited. A brief 
assessment of self-compassion and mindfulness scales outcomes will be performed using 
the responses collected from the “research only” section of the questionnaires. These 
results will help better understand the possible mechanisms between the intervention and 
clinical outcome for future ePCTs. These items will be removed at the conclusion of the 
pilot to decrease participant burden. All analysis will be performed in SAS 9.4 and 
significance determined using a two-sided alpha of 0.05.  
 

Page 25 of 32 
 
Equation 1.  
𝐶𝐶ℎ𝑎𝑎𝑎𝑎𝑎𝑎𝑒𝑒𝑖𝑖𝑖𝑖𝑖𝑖= 𝛽𝛽0 + δ𝑋𝑋𝑖𝑖𝑖𝑖𝑖𝑖+ 𝜔𝜔𝜔𝜔𝜔𝜔𝜔𝜔𝑖𝑖𝑖𝑖𝑖𝑖+ 𝜷𝜷𝑿𝑿𝒊𝒊+ 𝛾𝛾0𝑖𝑖𝑖𝑖+ 𝑣𝑣0𝑘𝑘+ 𝜖𝜖𝑖𝑖𝑖𝑖 
 
i = Participant Subscript,1, … , N  
k =  Cluster Subscript,1, …, K 
t = time period,1 = Control,2 = Intervention 
Changeitk = Change in efficacy outcome over period t 
Preitk = Pre measurment from period t 
For Control period:Pre = Q1, Change = Q2 - Q1 
For Intervention period:Pre = Q2, Change = Q3 - Q1 
xitk = Binary indicator for intervention for patient i in k at time t 
𝑿𝑿𝒊𝒊= Vector of covariates for pariticpant i 
β0 = General intercept of the model 
δ = Intervention effect (coefficient of xitk) 
ω = Baseline measurement adjustment effect (coefficient of Preitk) 
𝛃𝛃= Vector of coefficients associated with covarites in 𝐗𝐗𝐢𝐢 
γ0ik = Participant-specific random intercept with mean zero and variance σγ2 
v0k = Cluster-specific random intercept with mean zero and variance σv2 
𝜖𝜖itk = Random error with mean zero and variance σ𝜖𝜖2 
 
Aim 3 - Exploratory Feasibility Analysis: To explore the feasibility of obtaining online 
consent for research access to CP healthcare utilization records. The number of CPs who 
agree to access for themselves or the PLWED on Questionnaire 3 will be counted. While 
we will not specifically collect utilization data, the number of CPs who agree will inform 
the feasibility of including healthcare utilization as an outcome in a full-scale ePCT. Any 
differences in CP demographics between enrollees who opt-in and those who opt-out will 
be assessed. 
10 
DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms 
All data will be collected through the REDCap database embedded in the Presence Care 
website. If a course participant does not have access to a computer or the internet, there 
will be an option to speak with staff and complete the information via interview, which 
will be entered into the Presence Care website.  
10.2 Data Management  
All data will be entered directly into eCRFs in REDCap. The data system includes 
password protection and internal quality checks to identify data that appear inconsistent, 
incomplete, or inaccurate. Instructor logs from the MBDC classes will also be directly 
entered in REDCap.  

Page 26 of 32 
 
10.3 Quality Assurance  
10.3.1  Training 
MBDC program instructors are operating under standard of care based on Presence 
Care training. Instructors will be trained on data entry in REDCap, for example 
documenting attendance, etc. 
10.3.2 Quality Control Committee  
Not applicable. 
10.3.3 Metrics 
Metrics for quality control include the following: 
• Number of protocol deviations 
• Number of data entry errors 
• Number of technological issues with survey distribution   
10.3.4 Protocol Deviations 
It will be the responsibility of the PI to identify, document in REDCap, and report 
deviations as soon as possible.   
10.3.5 Monitoring 
The study team programmer will perform internal data quality checks on the data set 
provided through the Data Use Agreement with Presence Care.  Should independent 
monitoring become necessary, the PI will provide direct access study data for the 
purpose of monitoring and auditing by the sponsor/funding agency, and inspection by 
local and regulatory authorities. 
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board Review 
This study will be using Advarra as a central IRB. Any institution considered engaged in 
human subject research activities will complete a local IRB application as needed to cede 
oversight of the project to the central IRB. Any modifications to this protocol will be 
reviewed and approved by the IRB. 
11.2 Informed Consent Forms 
We request a waiver of informed consent for all aspects of this study, to include the use 
of electronic medical records for recruitment purposes, randomization assignment, 
enrollment and participation in the MDBC program, and the use of the collected program 
data.  We offer the following justifications for the waiver of informed consent: 
1. the research involves no more than minimal risk to the subjects; 

Page 27 of 32 
 
The mailing of an informational brochure to the patient about a program of potential 
interest to the family involves no more than minimal risk to the subject. People 
receive unsolicited mail from many sources including advertisement of services they 
are not interested in.  In addition, the MBPD program is already offered as a standard 
program in some places.  CPs who have completed the MBDC program to-date have 
provided overwhelmingly positive feedback about the program and its life-changing 
lessons (Figure 3). There have been no reported adverse events related to 
participation in MBDC.  The randomization component is minimal risk as well, 
particularly since the CP will be given the option to choose their preferred day and 
time if they decline the randomly assigned MBDC course.  We are assessing the 
feasibility of randomization and do not want to withhold the MBDC program from 
those for whom this is not feasible.  Use of the administrative data will be governed 
by a data use agreement. 
2. The research could not practicably be carried out without the requested waiver; 
The main purpose of this study is to assess the feasibility, acceptability, and fidelity 
of implementation of the Mindfulness Based Dementia Care (MBDC) program in 
practice.  Participation is voluntary and participants can drop out at any time and are 
free to skip any questions during the data collection process.  The centralized 
registration and administrative data collection process described herein is being 
created as a permanent part of MBDC through the Presence Care website. It would 
not be practicable to add research informed consent to this process as there is a 
possibility that the knowledge of being in a research study, or the burden of having to 
fill out extra paperwork would bias the feasibility, acceptability, and fidelity of 
implementation that we are hoping to measure. 
3. If the research involves using identifiable private information or identifiable 
biospecimens, the research could not practicably be carried out without using such 
information or biospecimens in an identifiable format;   
We require identifiable information for recruitment purposes. We could not mail 
without access to this identifiable information. Access to the administrative data from 
Presence Care will be governed by a data use agreement 
4. The waiver or alteration will not adversely affect the rights and welfare of the 
subjects; 
While we are requesting a waiver of informed consent for research purposes, 
participation in the program is completely voluntary, as is answering any of the 
questions in the data collection activities.  Participants can stop the program at any 
time.  We include a statement as part of the administrative data set questionnaires 
that: 1) answering questions is voluntary; 2) their answers may be shared in a de-

Page 28 of 32 
 
identified way with researchers. A “yield” approach for empty data fields will be used 
in the survey software that triggers an alert asking for, but not requiring the 
completion of data elements 
5.  Whenever appropriate, the subjects will be provided with additional pertinent 
information after participation 
Information about the MBDC program is already present in each site’s memory clinic 
newsletters and/or in notices in clinic common areas. We plan to invite patients, CPs, 
and families to a virtual, community presentation of the results of the study. 
Finally, please note that we do not consider the stakeholder interviews mentioned in Table 2 to 
be a human subjects research activity requiring consent. They consist of interviews with memory 
clinic leaders to discuss perspectives on recruitment for MBCD and opportunities for improving 
processes.   
We also request a partial HIPAA waiver of authorization for the use of HealthPartners EHR data 
for eligibility and recruitment purposes.  We offer the following justifications for the partial 
HIPAA waiver: 
1) Use or disclosure involves no more than minimal risk to the privacy of 
individuals because of the presence of at least the following elements: 
i) An adequate plan to protect health information identifiers from improper 
use or disclosure, 
The HealthPartners programmer will extract PHI data from the EHR and 
store on a secure server in a project folder that requires individual username 
permission to access. ;p] 
ii) An adequate plan to destroy identifiers at the earliest opportunity absent a 
health or research justification or legal requirement to retain them, and 
Identifiers will be destroyed after recruitment is complete.  To ensure that 
we do not duplicate mailings to patients, we need to retain identifiers until 
recruitment is complete, and cannot destroy sooner. 
iii) Adequate written assurances that the PHI will not be used or disclosed to a 
third party except as required by law, for authorized oversight of the 
research study, or for other research uses and disclosures permitted by the 
Privacy Rule 
PHI will not be used or disclosed to a third party except as required by law. 
Section 11.3 provides more detail. 
2) Research could not practicably be conducted without the waiver or alteration; and 

Page 29 of 32 
 
HealthPartners research staff will be contacting potential participants via mail to  
inform them of the study and therefore, potential subjects will not be available to sign a 
HIPAA Authorization. 
3) Research could not practicably be conducted without access to and use of PHI. 
We require PHI information for recruitment purposes. We could not mail without access 
to this identifiable information. 
11.3 Participant Confidentiality  
To protect against risk of breach of confidentiality, we will use REDCap, which is a 
secure web-based system used for data collection and is compliant with federal 
regulations (21 CFR Part 11, FISMA, HIPAA, and GDPR). 
To protect patient privacy, recruitment letters will be addressed to patients and mailed to 
the patient address. In case a patient may not be aware of a dementia diagnosis or not 
remember it, we will use sensitive language such as “information about a program of 
potential interest” and avoid statements that could cause alarm. 
Information will not be released without written permission of the participant, except as 
necessary for monitoring by IRB, the sponsor or persons working on behalf of the 
sponsor (i.e. IMPACT research study staff, the DSMB and/or Safety Officer), the FDA, 
the NIA, and the OHRP. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NIA, the OHRP, the FDA, or 
other government agencies as part of their duties to ensure that research participants are 
protected.  
12 
ETHICAL CONSIDERATIONS 
This study will be approved by a central IRB and conducted in accordance with the 
Belmont Report and the Declaration of Helsinki. 
 
13 
COMMITTEES 
Not applicable. 
14 
PUBLICATION OF RESEARCH FINDINGS 
This trial will be registered at ClinicalTrials.gov, and results information from this trial 
will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish 
results in peer-reviewed journals 
 

Page 30 of 32 
 
15 
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