The Senior Companion Program Plus for African American Caregivers of Persons With Alzheimer Disease and Related Dementias: Protocol for a Randomized Controlled Trial

Background Alzheimer disease and related dementias (ADRD) pose significant challenges as chronic health conditions in the United States. Additionally, there are notable disparities in the diagnosis and prevalence of ADRD among diverse populations. Specifically, African American populations have a higher risk of developing late-onset ADRD than White people, and missed diagnoses of ADRD are more common among older African American populations than older White populations. These disparities also impact African American ADRD family caregivers. Objective The overall goal of this project is to develop a culturally informed, lay provider psychoeducational intervention named Senior Companion Program Plus (SCP Plus), which is specifically designed for African American ADRD caregivers and is potentially accessible, affordable, and sustainable. Methods In the proposed explanatory sequential mixed methods study, a randomized controlled trial will be used that includes 114 African American family caregivers of a relative with ADRD who will participate in the 3-month SCP Plus program. Results The study was funded on September 15, 2018, by the National Institutes of Health (1R15AG058182-01A1). Data collection began on May 16, 2019, but due to COVID-19 restrictions, ended 12 months into the planned 27-month recruitment period on March 31, 2023. The study was completed in June 30, 2023, and currently the results are being analyzed. Conclusions The SCP Plus offers promise as an intervention that utilizes an existing platform for the delivery of a lay provider intervention and offers a novel approach for addressing gaps in accessible, community-based support for caregivers of people with ADRD. Trial Registration ClinicalTrials.gov NCT03602391; https://classic.clinicaltrials.gov/ct2/show/NCT03602391 International Registered Report Identifier (IRRID) RR1-10.2196/49679

ZRG1 NRCS-V (08) FIELDS, N PUBLIC HEALTH RELEVANCE: The Senior Companion Program Plus (SCP Plus): A Psychoeducational Intervention for African American Dementia Caregivers Project Narrative Utilizing the Senior Companion Program as a platform for a dementia caregiving intervention offers an innovative approach for providing affordable services and supports in a community setting and is potentially sustainable as it expands the services of an existing program. The Senior Companion Program (SCP Plus) will advance the scientific knowledge about how dementia caregivers from minority populations can build coping skills and protective factors through engagement with lay health care providers such as Senior Companions. Implementation of the SCP Plus will increase insight into the sociocultural experiences of dementia caregivers and will enhance the ability of community-based providers to meet the unique needs of minority caregiver populations.

CRITIQUE 1
Significance: 4 Investigator(s): 1 Innovation: 4 Approach: 4 Environment: 1 Overall Impact: The investigative team for this resubmitted R-15 application proposes to utilize a randomized sequential 2-group mixed methods design for this 3-year study to examine the effects of an in-home intervention utilizing Senior Companions (SCP) to deliver a psychoeducational intervention (SCP Plus) to 57 treatment group community-residing caregivers of African American (AA) older adults diagnosed with Alzheimer's Disease and Related Disorders (ADRD). Caregiver outcomes include reduced stress and burden, improved coping skills, and satisfaction with social support. The SCP program has been adapted from a previously tested intervention using trained lay companions to deliver education in the home, and will be delivered across 6 sites in 3 states. The potential impact of the proposed study is supported by the potential for the SCP Plus treatment to improve outcomes for family caregivers, notably at-risk AA caregivers. However, this potential impact is weakened by lack of clearly defined additive aspects of the proposed study beyond the current well-tested and disseminated caregiver interventions, some of which utilize racially matched lay interventionists. The study has potential to increase the research environment at the sponsoring university although involvement of the 3 undergraduate students as site managers for the remote sites is not clearly defined. Culturally sensitive aspects of the treatment are also not clearly integrated. The PI has a record of involvement in research with caregiving populations and with graduate students. A strong research team has been assembled, including expert consultation from Dr. Gaugler. Designing treatments specifically for racial/ethnic minorities is not essentially innovative, given the proliferation of culturally specific treatments over the past decade, with cited references to support this innovation being >10 years. Racially matched senior companions have also been previously utilized to deliver targeted treatments. Scientific rigor is evident throughout the research methods including the sampling plan, attention to treatment fidelity, detailed training procedures, and well-supported outcome measures. The 6 clinical sites will yield close to 500 Senior Companions across the sites, increasing the likelihood of recruiting an adequate interventionist sample. Some moderate and minor weaknesses in the research methods were identified, including lack of a true time-controlled comparison group and some human subjects concerns. The environment at the University of Texas appears adequate to support the proposed study. The investigators have adequately addressed the majority of weaknesses identified in the previous review. Overall, some evidence for potential impact, a strong research team, and scientific rigor in some of the proposed research methods provides some support for this study, with support being lessened by weaknesses in the potential impact and innovations, and minor to moderate methodological weaknesses.

Strengths
 The potential impact of the proposed study primarily rests in the intent to improve health-related and quality of life outcomes for AA family caregivers of persons with ADRD.
 Utilizing existing Senior Companion programs increases the likelihood of successfully carrying out the proposed study.
 The study has potential to enrich the research environment at the sponsoring university.

Weaknesses
 The scientific rationale supporting the need for further research testing caregiver support and education interventions lacks detail and does not represent the breadth of well-tested treatments.
 Some in-home caregiver treatments utilize racially matched lay interventionists, with no clearly defined additive aspects of the proposed study.
 Potential impact is further weakened by lack of a plan to assure the treatment is culturally sensitive.

Strengths
 The PI has a record of involvement in research with caregiving populations, including persons with ADRD and with graduate students.
 A strong research team has been assembled, including expert consultation from Dr. Gaugler.
 A biostatistician has been added to the study team, providing needed expertise in data analytic approaches.
Weaknesses  None noted.

Innovation:
Strengths  Not essentially innovative.

Weaknesses
 Designing and testing treatments specifically for racial/ethnic minorities is not essentially innovative, given the proliferation of culturally specific treatments over the past decade, with cited references to support this innovation being >10 years.
 Senior companions have also been previously utilized to deliver targeted treatments within the home setting, with racial matching often being inherent in these studies.

Approach:
Strengths  Scientific rigor is evident throughout the research methods including the sampling plan, attention to treatment fidelity, detailed SC training procedures, and well-supported outcome measures.
 Sex as a biological variable was indirectly addressed as a covariate in the proposed data analyses.
1 R15 AG058182-01A1 5 ZRG1 NRCS-V (08) FIELDS, N  Blinding of assessors to treatment condition lessens the chance of bias.  The 6 clinical sites will yield close to 500 Senior Companions across the sites, increasing the likelihood of recruiting an adequate interventionist sample.

 No attention-control component is included for the comparison group.
 Methods for controlling for possible contamination of groups through data analytic approaches are not specified and are not inherently clear (p.53) as written.
 Training for data collectors (interviewers?) and student research assistants is not specified, raising concerns regarding consistent data collection across study sites and over time.
 The power analysis is somewhat weak and it appears to be based on 114 subjects/group rather than the proposed 57 subjects/group.  While this study is proposed as a mixed methods study, specific approaches to utilize the qualitative findings to inform the quantitative findings are not included, decreasing the likelihood that a true mixed methods approach will be realized.

Strengths
 The environment at the University of Texas appears adequate to support the proposed study.
Weaknesses  None noted.

Protections for Human Subjects:
Unacceptable Risks and/or Inadequate Protections  Some human subjects' concerns are evident, as data will be collected from the Senior Companions, although the consent process is unclear.

Data and Safety Monitoring Plan (Applicable for Clinical Trials Only):
Acceptable o A D&SM plan is included.

Budget and Period of Support:
Recommend as Requested

CRITIQUE 2
Significance: 1 Investigator(s): 1 Innovation: 3 Approach: 2 Environment: 1 Overall Impact: The proposed project has high public health relevance and will provide a focused context for education and training of students. There are scientific gaps in knowledge regarding how best to address the growing problem of Alzheimer's disease and related dementia (ADRD) that impacts African American patients and their caregivers. The study is responsive to national recommendations. There is a strong scientific premise for the study and it builds upon an existing program and implementation infrastructure. The proposed RCT design is well-described and the implementation plan builds upon a national model and a pilot study led by the investigators. The project will be co-led by new investigators with complementary areas of expertise. The PIs are joined by experienced investigators. The commitment and experience with training students appears reasonable and there is a track record of integrating students within research projects. Overall this is a strong project with identified collaborators that has multiple opportunities to engage students.

Significance:
Strengths  Alzheimer's Disease has a major economic and social impact in the US. AD is debilitating for the person diagnosed and caregivers often face a host of challenges including depression, anxiety, and health impairments in comparison to non-caregivers.
 Patients who reside in the community often receive care from caregivers who provide uncompensated care and who suffer from poor psychosocial and psychological health 1 R15 AG058182-01A1 7 ZRG1 NRCS-V (08) FIELDS, N challenges. A strong rationale is provided for peer-led psychoeducational models to support AD patients and their caregivers. Additionally, information is provided that supports the need to assess cultural factors and/or contextual factors that may be relevant for African Americans. There is a strong scientific premise that African Americans have differential patterns of careseeking.
 African American older adults are at higher risk for developing late-onset AD compared to whites and their caregivers generally have poorer health and health behaviors than their white caregiver counterparts suggesting a need for interventions to target this subgroup.
 The intervention leverages an existing national caregiving program in three states to integrate a psycho-educational intervention, which should enhance dissemination and/or sustainability.
 Provision of the intervention in the home may have potential for greater impact than an out of home intervention.

Weaknesses
 No score-driving weaknesses

Strengths
 Two investigators will serve as MPIs on the project. Dr. Fields' work is focused on cultural issues in caregiving for individuals with dementia. She led a pilot study that informed the proposed study. While at UT, Dr. Fields has had 8 students work with her on research projects over the past 4 years. Dr. Fields is a new investigator focused on cultural issues in caregiving for individuals with dementia. In addition to clinical experience serving persons with dementia she led a pilot study of the SCP Plus. Dr. Xu has expertise in family gerontology and collaborated with Dr. Fields on the SCP pilot project.

Weaknesses
 No score-driving weaknesses.

Innovation:
Strengths  Innovative components of solely focusing on African American caregivers, inclusion of culturally relevant factors (e.g., religious coping), delivery of the intervention in the home setting and integration of a qualitative component for persons in specified quartiles may inform intervention adaptation.

Weaknesses
 The SCP program appears well-developed and wide-spread which limits innovation.

Approach:
Strengths  A rigorous research design is proposed (RCT). The inclusion of multiple research sites across three states may add to generalizability and also allow for variation in sample characteristics.
 The SCP plus is based on a dementia care giving program and the modules of the Senior Companion Program are well detailed. 1 R15 AG058182-01A1 8 ZRG1 NRCS-V (08) FIELDS, N  The sociocultural stress and coping model will be employed as the conceptual model to guide the intervention and the study. Key variables relevant to model and measures are wellintegrated (coping style, social support, well-being)  The setting and process for engaging peer companions is well described.
 The PIs and intervention staff will monitor the quality of intervention delivery using various methods that includes a checklist.
 The plan for recruitment and hiring of students is described.
 Over the course of the project undergraduate, graduate and doctoral students will be integrated as research assistants. A process is outlined for selecting students based on performance in key courses. Specific roles of the students are outlined.
 The proposed training activities and level of integration with the research projects are likely to be beneficial to students.

Weaknesses
 There was some question about the integration of the two phases of the qualitative data collection although there is detail on the content analysis.

Strengths
 The interventions will be nested within an existing national SCP that trains and deploys peer companions to families that include a person diagnosed with AD.
 The environment appears well suited for the proposed research.
 Multiple sites and programs are included that have the capacity to implement the project.

Weaknesses
 No score-driving weaknesses.

Protections for Human Subjects:
Acceptable Risks and/or Adequate Protections  Processes for maintaining confidentiality and implementing participant protections is described in the application.

Data and Safety Monitoring Plan (Applicable for Clinical Trials Only):
Acceptable o Plans to monitor and report adverse events are described.  More detail on the explanatory sequential mixed method design is included. The fidelity plan was revised.

Not Applicable (No Foreign Organizations)
Select Agents:

CRITIQUE 3
Significance: 5 Investigator(s): 4 Innovation: 3 Approach: 6 Environment: 3 Overall Impact: The purpose of this study is to evaluate "SCP Plus"--a 9 module psychoeducation intervention delivered by lay providers (e.g. peers referred to as Senior Companions)--on outcomes of caregiver knowledge, burden, wellbeing and coping at 3-and 6-months when compared to a usual care control group. The intervention will be tested across several senior service agencies with existing SCP programs in Texas, Louisiana and Arkansas. This R-15 project will also provide mentored research learning experiences to social work students in community-based research with high risk, high need populations. Strengths of the application include the use of RCT design, a conceptually grounded intervention and the use of well-validated measures. Weaknesses are the lack of evidence supporting the scientific premise, the limited generalizability due to restricting sample to African American caregivers who have access to and participate in SCP programs, lack of details on how the intervention is culturally tailored to address the needs of low income African American caregivers, and missing details on data collection procedures. Thus, despite the importance of this topic, the moderate level 1 R15 AG058182-01A1 10 ZRG1 NRCS-V (08) FIELDS, N weaknesses limit the potential impact of the study on advancing interventions to support dementia caregivers.

Strengths
 The study addresses an important problem--the need for culturally sensitive psychoeducational interventions to support family caregivers of persons with dementia, especially those in underserved communities.

Weaknesses
 The scientific premise of the study is that trained peer volunteers without any prior clinical background or expertise can provide a 9-week psychoeducational intervention that improves coping, social support and wellbeing in a high-risk, high need population of low income African American dementia caregivers. The evidence provided to support this premise is weak.
 It remains unclear why the investigators are solely focusing on low income African American caregivers in their study sample. There is little information provided on how SCP Plus is culturally adapted to meet the specific needs of this population of dementia caregivers, and moreover how lay providers are prepared to address these complex needs.

Investigator(s):
Strengths  Drs. Fields and Xu have beginning programs of research in psychoeducational interventions for minority dementia caregivers They bring established record of mentoring undergraduate and graduate students and have successfully collaborated in the past.
 Dr Gaugler is an expert in dementia caregiving interventions. He will provide 27 hours per year of consultation on implementation, data collection, analysis and dissemination.
 Multi PI plan is appropriate Weaknesses  Dr. Williams is an Assistant professor at UVA. It is unclear how her expertise will be utilized (1 1 R15 AG058182-01A1 11 ZRG1 NRCS-V (08) FIELDS, N  Use of RCT design to enhance rigor  Use of well established, well validated measures of caregiver outcomes, mapped to conceptual framework  The intervention is conceptually grounded in the theory of stress and coping.
 Up to six social work students will receive research training as part of the proposed research study  Sex is considered as a variable--appropriate sub analysis is proposed to study gender-based differences.

Weaknesses
 Generalizability of the findings is limited since sample population is caregivers enrolled in SCP program. The majority of dementia caregivers, and particularly African American caregivers, are not receiving supportive services. The investigators do not address this significant limitation  The investigators do not outline specific approaches to engage the low-income African-American community (other than letters of support from agencies)  No procedures detailing data collection such as training and monitoring of data collectors, process for data collection, or blinding of data collectors.
 No attention in analysis to controlling for likely differences across study sites/States.

Environment:
Strengths  Letters of support from sites identifying Senior Companions and eligible caregivers are provided.

Weaknesses
 While rich resources are available at UT-Arlington to enhance the research and mentorship activities planned, there is no discussion of how these resources will be engaged to provide additional research training and mentorship to students. ZRG1 NRCS-V (08) FIELDS, N  Only partially responsive to prior reviews and concerns remain that were raised in the prior review. For example, added biostatistician to study team but does not address the need to capitalize on other rich research resources available at UT, rather relies on 2 external consultants. The external validity/generalizability remains limited given the sample population of persons receiving services. Consultants are required to absent themselves from the room during the review of any application if their presence would constitute or appear to constitute a conflict of interest.