Including Socially Isolated Black, Older Old Adults (Aged 80 and Above) with and without Mild Cognitive Impairment in a Clinical Trial: Recruitment Strategies and Perspectives

Figures & data

Box 1 Overall Recruitment Statistics for the Two Study Sites

Inclusion Criteria: 1) Age 80 or older (later changed to 75 years and older). 2) Consent to participate in the study and to receive MRI (if safely and comfortably able to receive MRI). 3) Socially isolated defined by at least one of the following: a. Score ≤12 on the 6-item Lubben Social Network Scale.^Citation15, b. Answers “Often” to at least one question on the Hughes et al. Three-Item UCLA Loneliness Scale.^Citation16 c. Engages in conversations lasting 30 minutes or longer no more than twice per week, per subject self-report (added later as an option). 4) Adequate vision to use study technology and complete all neuropsychological tests throughout the study, defined by the following: a. Able to see well enough to read a newspaper, wearing glasses if needed but not using a magnifying glass. 5) Adequate hearing to use study technology and complete all neuropsychological tests throughout the study, defined as: a. Able to hear well enough to meet the telephone screening. 6) Sufficient ability to understand English to complete protocol-required testing. 7) Normal cognition or mild cognitive impairment (MCI), as assessed by the trial neuropsychologist. 8) Sufficiently able to comply with protocol assessments and procedures, in the opinion of the assessor. Exclusion Criteria: 1) Identified as having dementia based on either of the following criteria: a. Self-reported diseases associated with dementia, such as Alzheimer’s disease, vascular dementia, Lewy body dementia, frontotemporal dementia, normal pressure hydrocephalus, or Parkinson’s disease, b. Diagnosis of dementia by a trial neuropsychologist. 2) Anticipating significant change in the living arrangement within the upcoming year. 3) Severely depressed, operationally defined as a 15-item GDS score > 7.^Citation17 4) The significant disease of the central nervous system, such as brain tumor, seizure disorder, subdural hematoma, or effective stroke, per subject report. 5) Current (within two years of screening) alcohol or substance abuse. 6) Unstable or significantly symptomatic psychiatric disorder, such as major depression, schizophrenia, posttraumatic stress disorder, or bipolar disorder. 7) Dangerous or especially symptomatic cardiovascular disease, such as coronary artery disease with frequent angina or congestive heart failure with shortness of breath at rest. 8) Unstable insulin-dependent diabetes mellitus is defined as meeting any of the following criteria: a. Received a diagnosis of Type 1 Diabetes, b. Started taking insulin within three months of the screening visit, c. Hospitalization for hypoglycemia within one year of screening. 9) Active systemic cancer within five years of the screening visit (Gleason Grade < 3 prostate cancer and non-metastatic skin cancers are acceptable). 10) Surgery that required full sedation with intubation within six months of screening (sedation for minor procedures is acceptable). 11) More than one overnight hospital-stay within three months of the screening visit. 12) Any other condition that, in the investigator’s opinion, is severe enough to cause study participation to impact participant or study team rights or wellbeing negatively.

Table 1 Overall Recruitment Statistics for the Two Study Sites

Recruiting Potential Subjects	Midwest Recruitment Site (Blacks)			Pacific Coast Recruitment Site (Whites)
	Number	% of Previous Row	% of Total	Number	% of Previous Row	% of Total
Contact Attempted	12,141			17,523
Phone Screened	428	3.5%	3.5%	711	4.1%	4.1%
Eligible	80	18.7%	0.7%	314	44.2%	1.8%
Consented/Screened	55	68.8%	0.5%	210	66.9%	1.2%
Enrolled	39	70.9%	0.3%	147	70.0%	0.8%
Screen Fail	16	29.1% of Eligible	0.1%	63	30.0% of Eligible	0.4%

Table 2 Recruitment Sources for Black Participants at Midwest Site

Recruitment Sources at the Midwest Site	All Phone Screen Participants N (%)	Enrolled Participants N (%)	Enrollment Rate (Enrolled/Phone Screened)
Healthier Black Elders (HBE)	208 (49%)	11 (28%)	5.2%
Election List Letter (ELL)	121 (28.3%)	9 (23%)	7.4%
Calls Responding to Advertisement	47 (11%)	7 (18%)	14.8%
Outreach-Senior Housing	19 (4.4%)	4 (10%)	21.0%
Other (eg, Conference, Medicare Programs)	12 (3%)	1 (3%)	8.3%
University Health Research list	9 (2.1%)	2 (5%)	22.2%
Area Agency on Aging 1-B	5 (1.2%)	0
Outreach- Churches	2 (0.5%)	0
Website	2 (0.5%)	0
Unknown	3 (0.7%)	5 (13%) (2 phone screen unknown + 3 missing data on source information)
Total	428	39

Figure 1 Recruitment Flow Comparison. This figure illustrates the recruitment process, comparing potential participants from the Midwest site (Black older adults) and the Pacific Coast (White older adults). The flow chart outlines the following stages: 1. Initial Contact: The initial contact was made with potential participants. 2. Telephone Screen Agreement: Basic eligibility is assessed and if criteria are met, a home visit is scheduled. 3. Home Visit with Consent and Screen: Eligible participants undergo a home visit for obtaining consent and further screening. 4. Number of Screen Failures: This indicates the count of participants who did not meet the screening process. 5. Randomization: Participants are randomly assigned to experimental and control groups. 6. Withdrawal Before the Trial: The number of participants who withdrew before the trial commences is shown. 7. Trial Start: The figure compares the participants who started the trial for the experimental and control groups for each site.

Table 3 Reasons for Screen Failures During in-Home Screening for the Two Study Sites

Screen Failures	Blacks	% By Race	% Of Total	Mainly Whites	% By Race	% Of Total	Total
Inability to Continue^a	9	31.0%	9.7%	8	12.5%	8.6%	17
Not isolated	8	27.6%	8.6%	23	36.0%	24.7%	31
Dementia	4	13.8%	4.3%	6	9.4%	6.5%	10
Unstable/Major Disease	3	10.4%	3.2%	13	20.3%	14.0%	16
Hospital/Sedation	2	7.0%	2.2%	2	3.0%	2.2%	4
Depression	1	3.4%	1.1%	6	9.4%	6.5%	7
Hearing Loss	1	3.4%	1.1%	0	0%	0%	1
Rights and Safety	1	3.4%	1.1%	0	0%	0%	1
Did not consent	0	0.0%	0.0%	6	9.4%	6.5%	6
Total Screen Item Failures	29	100.0%	31.3%	64	100.0%	8.8%	93
Total Subject Failures	16			63

Notes: ^aSince telephone contact, unexpected life changes occurred as follows: moving, time commitments, falls, recent medical issues, and being unable to contact the subject or the emergency contact after the telephone screen.

Lubben J, Blozik E, Gillmann G, et al. Performance of an abbreviated version of the Lubben social network scale among three European community-dwelling older adult populations. Gerontologist. 2006;46(4):503–513. doi:10.1093/geront/46.4.503

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