Trial Outcomes & Findings for Feasibility of a Systems Approach for Alzheimer's Services Among Latinos Attending Primary Care Practices (NCT NCT04418232)
NCT ID: NCT04418232
Last Updated: 2024-12-20
Results Overview
Metrics of the number of providers who agree to be trained per month
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
243 participants
Primary outcome timeframe
During the 9 months of the provider intervention period
Results posted on
2024-12-20
Participant Flow
This study includes 100 dyads. Each dyad is formed by a unique caregiver and a care recipient. Ten care recipients are in more than one dyad, as more than one of their caregivers participated in the study.
Participant milestones
| Measure |
Alianza Latina
The main components of Alianza Latina were:
1. Primary care provider education: This training was informed by the Health Belief Model and Social Learning Theory and included clinically-focused lectures, case examples with discussion, videos and materials. Topics included dementia detection and diagnosis, treatment, and care, early detection, patient empowerment, and cultural competence. The modality of all training events was live and online via videoconferences.
2. Coordinated care: This program provided Latino dementia patients with enhanced chronic care through bilingual Health Navigators. Alianza Latina is a six-month bilingual intervention, designed to cater to the unique needs of Latino caregivers. It integrates CuidaTEXT, an SMS program, with monthly phone consultations facilitated by a trained coach from the research team. These consultations aim to identify unaddressed needs and provide necessary support. Participants in CuidaTEXT receive scheduled messages and can also request on-demand assistance by texting. CuidaTEXT entails sending 1-3 automated daily messages covering various aspects such as logistics, dementia education, self-care, social support, end-of-life care, managing dementia-related behaviors, and problem-solving strategies. Additionally, participants could text keyword-based queries for immediate assistance on the above-mentioned topics and engage in live chat sessions with the coach for further guidance upon request.
|
|---|---|
|
Overall Study
STARTED
|
243
|
|
Overall Study
COMPLETED
|
172
|
|
Overall Study
NOT COMPLETED
|
71
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
Baseline characteristics by cohort
| Measure |
Alianza Latina
n=243 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
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Age, Categorical
Care recipients · <=18 years
|
0 Participants
n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Age, Categorical
Care recipients · Between 18 and 65 years
|
8 Participants
n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Age, Categorical
Care recipients · >=65 years
|
76 Participants
n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Age, Categorical
Caregivers · <=18 years
|
0 Participants
n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Age, Categorical
Caregivers · Between 18 and 65 years
|
90 Participants
n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Age, Categorical
Caregivers · >=65 years
|
10 Participants
n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Age, Categorical
Primary care providers · <=18 years
|
0 Participants
n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Age, Categorical
Primary care providers · Between 18 and 65 years
|
47 Participants
n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Age, Categorical
Primary care providers · >=65 years
|
12 Participants
n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Age, Continuous
Care recipients
|
78.2 years
STANDARD_DEVIATION 10.2 • n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers)
|
|
Age, Continuous
Caregivers
|
52.0 years
STANDARD_DEVIATION 10.2 • n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers)
|
|
Age, Continuous
Primary care providers
|
49.5 years
STANDARD_DEVIATION 12.8 • n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers)
|
|
Sex: Female, Male
Care recipients · Female
|
71 Participants
n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Sex: Female, Male
Care recipients · Male
|
13 Participants
n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Sex: Female, Male
Caregivers · Female
|
82 Participants
n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Sex: Female, Male
Caregivers · Male
|
18 Participants
n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Sex: Female, Male
Primary care providers · Female
|
42 Participants
n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Sex: Female, Male
Primary care providers · Male
|
17 Participants
n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Ethnicity (NIH/OMB)
Care recipients · Hispanic or Latino
|
84 Participants
n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Ethnicity (NIH/OMB)
Care recipients · Not Hispanic or Latino
|
0 Participants
n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Ethnicity (NIH/OMB)
Care recipients · Unknown or Not Reported
|
0 Participants
n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
|
95 Participants
n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
|
4 Participants
n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
|
1 Participants
n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Ethnicity (NIH/OMB)
Primary care providers · Hispanic or Latino
|
3 Participants
n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Ethnicity (NIH/OMB)
Primary care providers · Not Hispanic or Latino
|
50 Participants
n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Ethnicity (NIH/OMB)
Primary care providers · Unknown or Not Reported
|
6 Participants
n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Care recipients · American Indian or Alaska Native
|
0 Participants
n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Care recipients · Asian
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0 Participants
n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Care recipients · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Care recipients · Black or African American
|
1 Participants
n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Care recipients · White
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15 Participants
n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Care recipients · More than one race
|
0 Participants
n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Care recipients · Unknown or Not Reported
|
68 Participants
n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
|
0 Participants
n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Caregivers · Asian
|
0 Participants
n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Caregivers · Black or African American
|
1 Participants
n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Caregivers · White
|
25 Participants
n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Caregivers · More than one race
|
2 Participants
n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
|
72 Participants
n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Primary care providers · American Indian or Alaska Native
|
4 Participants
n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Primary care providers · Asian
|
0 Participants
n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Primary care providers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Primary care providers · Black or African American
|
2 Participants
n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Primary care providers · White
|
46 Participants
n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Primary care providers · More than one race
|
4 Participants
n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
|
Race (NIH/OMB)
Primary care providers · Unknown or Not Reported
|
3 Participants
n=59 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).
|
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Region of Enrollment
United States
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243 participants
n=243 Participants
|
|
Caregivers' relation to care recipients
Children
|
73 Participants
n=100 Participants • Number analyzed in row differs from overall because it only refers to caregivers' relation to care recipients.
|
|
Caregivers' relation to care recipients
Partner
|
11 Participants
n=100 Participants • Number analyzed in row differs from overall because it only refers to caregivers' relation to care recipients.
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|
Caregivers' relation to care recipients
Children-in-law
|
4 Participants
n=100 Participants • Number analyzed in row differs from overall because it only refers to caregivers' relation to care recipients.
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|
Caregivers' relation to care recipients
Other
|
12 Participants
n=100 Participants • Number analyzed in row differs from overall because it only refers to caregivers' relation to care recipients.
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|
Dementia diagnosis
Alzheimer's dementia
|
38 Participants
n=84 Participants • Number analyzed in row differs from overall, because analyses only refer to care recipients.
|
|
Dementia diagnosis
Unspecified dementia
|
27 Participants
n=84 Participants • Number analyzed in row differs from overall, because analyses only refer to care recipients.
|
|
Dementia diagnosis
Vascular dementia
|
5 Participants
n=84 Participants • Number analyzed in row differs from overall, because analyses only refer to care recipients.
|
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Dementia diagnosis
Lewy Bodies/Parkinson's dementia
|
5 Participants
n=84 Participants • Number analyzed in row differs from overall, because analyses only refer to care recipients.
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Dementia diagnosis
Mixed dementia
|
4 Participants
n=84 Participants • Number analyzed in row differs from overall, because analyses only refer to care recipients.
|
|
Dementia diagnosis
Frontotemporal dementia
|
2 Participants
n=84 Participants • Number analyzed in row differs from overall, because analyses only refer to care recipients.
|
|
Dementia diagnosis
Other
|
2 Participants
n=84 Participants • Number analyzed in row differs from overall, because analyses only refer to care recipients.
|
|
Dementia diagnosis
Mild Cognitive Impairment
|
1 Participants
n=84 Participants • Number analyzed in row differs from overall, because analyses only refer to care recipients.
|
|
Years of education
Care recipients
|
11.2 years
STANDARD_DEVIATION 20.4 • n=84 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients and caregivers).
|
|
Years of education
Caregivers
|
12.4 years
STANDARD_DEVIATION 4.4 • n=100 Participants • Number analyzed in row differs from overall because we are reporting different samples (care recipients and caregivers).
|
PRIMARY outcome
Timeframe: During the 9 months of the provider intervention periodMetrics of the number of providers who agree to be trained per month
Outcome measures
| Measure |
Alianza Latina
n=59 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
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|---|---|
|
Provider Recruitment Feasibility
|
1.44 Providers trained per month
Standard Deviation 2.74
|
PRIMARY outcome
Timeframe: During the 9 months of the provider intervention periodPopulation: Primary care providers that are part of Aim 2a
Metrics of the percentage of providers who continue to partner with the study team by the end of the provider intervention period
Outcome measures
| Measure |
Alianza Latina
n=59 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
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|---|---|
|
Provider Retention Feasibility
|
11 Participants
|
PRIMARY outcome
Timeframe: 9 months (end of the provider intervention period)Population: Primary care providers that are part of Aim 2a
Percentage of providers able to implement screenings in regular workflow, measured via survey with the question "To what extent were you able to implement screenings in regular workflow" with three response options: "not at all", "to some degree", "usually", "almost always" and "always"
Outcome measures
| Measure |
Alianza Latina
n=59 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
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|---|---|
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Provider Fidelity Feasibility 1
not at all
|
1 Participants
|
|
Provider Fidelity Feasibility 1
to some degree
|
5 Participants
|
|
Provider Fidelity Feasibility 1
usually
|
19 Participants
|
|
Provider Fidelity Feasibility 1
almost always
|
9 Participants
|
|
Provider Fidelity Feasibility 1
always
|
8 Participants
|
|
Provider Fidelity Feasibility 1
Missing
|
17 Participants
|
PRIMARY outcome
Timeframe: During the 9 months of the provider intervention periodPopulation: Primary care providers that are part of Aim 2a
Metrics of the percentage of providers who complete baseline and follow-up surveys about dementia knowledge, attitudes and skills
Outcome measures
| Measure |
Alianza Latina
n=59 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
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|---|---|
|
Provider Assessment Feasibility 1
|
43 Participants
|
PRIMARY outcome
Timeframe: During the 9 months of the provider intervention periodPopulation: Primary care providers that are part of Aim 2a
Metrics of the Number of referrals to Health Navigator per month
Outcome measures
| Measure |
Alianza Latina
n=59 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
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|---|---|
|
Provider Fidelity Feasibility 2
|
5.77 Referrals per month
Standard Deviation 3.45
|
PRIMARY outcome
Timeframe: 9 months (end of the provider intervention period)Population: Primary care providers that are part of Aim 2a
Survey question including a 5-item Likert scale on satisfaction with training (not at all to very much)
Outcome measures
| Measure |
Alianza Latina
n=59 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Overall Provider Satisfaction With Training
Not at all
|
0 Participants
|
|
Overall Provider Satisfaction With Training
Slightly
|
2 Participants
|
|
Overall Provider Satisfaction With Training
Moderately
|
4 Participants
|
|
Overall Provider Satisfaction With Training
very much
|
15 Participants
|
|
Overall Provider Satisfaction With Training
Extremely
|
21 Participants
|
|
Overall Provider Satisfaction With Training
Missing
|
17 Participants
|
PRIMARY outcome
Timeframe: 9 months (end of the provider intervention period)Population: Primary care providers that are part of Aim 2a (Only among the people who reported using health navigators)
Survey question including a 5-item Likert scale on the perceived importance of Navigators to providers (not at all to very much)
Outcome measures
| Measure |
Alianza Latina
n=1 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Importance of Navigators to Providers
Not at all
|
0 Participants
|
|
Importance of Navigators to Providers
Slightly
|
0 Participants
|
|
Importance of Navigators to Providers
Moderately
|
0 Participants
|
|
Importance of Navigators to Providers
Very much
|
0 Participants
|
|
Importance of Navigators to Providers
Extremely
|
1 Participants
|
PRIMARY outcome
Timeframe: During the 15 months of the whole intervention periodPopulation: The Overall Number of Participants Analyzed is greater than the number Started in the Participant Flow because this variable reports the dyads who end up enrolling (100) out of the ones referred (127)
Metrics of percentage of referred Latino dementia dyads who enroll in Health Navigator services
Outcome measures
| Measure |
Alianza Latina
n=127 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Participant Recruitment Fidelity
|
78.7 Percentage of dyads
|
PRIMARY outcome
Timeframe: During the 6 months of the Navigator intervention periodPopulation: The Overall Number of Participants Analyzed is greater than the number Started in the Participant Flow because this variable reports the dyads who are followed up (88) out of the ones referred (127)
Metrics of percentage of referred Latino dementia dyads followed up at six months
Outcome measures
| Measure |
Alianza Latina
n=127 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Participant Retention Fidelity
|
69.3 Percentage of dyads
|
PRIMARY outcome
Timeframe: During the 6 months of the Navigator intervention periodPopulation: Participants responding to these are dyads (caregivers and, when possible, care recipients)
Metrics of the percentage of planned baseline and follow-up survey ratings completed
Outcome measures
| Measure |
Alianza Latina
n=100 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Participant Assessment Fidelity
|
77 Percent of dyads
|
PRIMARY outcome
Timeframe: During the 6 months of the Navigator intervention periodPopulation: Participants responding to these are dyads (caregivers and, when possible, care recipients)
Metrics of the percentage of referred Latino dementia dyads who attend at least 50% of Health Navigator visits
Outcome measures
| Measure |
Alianza Latina
n=100 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Participant Treatment Adherence
|
29 Percentage of dyads
|
PRIMARY outcome
Timeframe: 6 months after baselinePopulation: Participants responding to these are caregivers
Survey question including a 5-item Likert scale on caregivers' satisfaction with clinic services (not at all to very much)
Outcome measures
| Measure |
Alianza Latina
n=100 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Overall Participant Satisfaction With the Clinic Side of the Intervention
Not at all
|
7 Participants
|
|
Overall Participant Satisfaction With the Clinic Side of the Intervention
Somehow
|
13 Participants
|
|
Overall Participant Satisfaction With the Clinic Side of the Intervention
Very
|
52 Participants
|
|
Overall Participant Satisfaction With the Clinic Side of the Intervention
Extremely
|
15 Participants
|
|
Overall Participant Satisfaction With the Clinic Side of the Intervention
Missing
|
12 Participants
|
|
Overall Participant Satisfaction With the Clinic Side of the Intervention
Does not know
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 months after baselinePopulation: Participants responding to these are caregivers
Survey question to the caregiver including a 5-item Likert scale on satisfaction with Navigator services (not at all to very much)
Outcome measures
| Measure |
Alianza Latina
n=100 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Overall Participant Satisfaction With the Navigator Side of the Intervention
Not at all
|
0 Participants
|
|
Overall Participant Satisfaction With the Navigator Side of the Intervention
Somehow
|
5 Participants
|
|
Overall Participant Satisfaction With the Navigator Side of the Intervention
Very
|
43 Participants
|
|
Overall Participant Satisfaction With the Navigator Side of the Intervention
Extremely
|
40 Participants
|
|
Overall Participant Satisfaction With the Navigator Side of the Intervention
Missing
|
12 Participants
|
PRIMARY outcome
Timeframe: 6 months after baselinePopulation: Participants responding to these are caregivers
Survey question to the caregiver including an open-ended question about which aspects of the intervention they would change
Outcome measures
| Measure |
Alianza Latina
n=100 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Participant Suggestions of Improvement
Responded
|
88 Participants
|
|
Participant Suggestions of Improvement
Missing
|
12 Participants
|
PRIMARY outcome
Timeframe: 6 months after baselinePopulation: 87 respondents
10-item checklist administered to the dyads asking about the implementations of different aspects of dementia service guidelines
Outcome measures
| Measure |
Alianza Latina
n=87 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Practitioner Adherence to Guideline Recommendations
|
9 Guideline Items in the checklist covered
Interval 6.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline and 6 months from baselinePopulation: Participants responding to these are caregivers on behalf of care recipients
Brief version of the Neuropsychiatry Inventory Questionnaire: This is a validated clinical instrument for evaluating psychopathology in dementia. If any of the 12 neuropsychiatric symptoms is present, caregivers rate their loved one's severity on a three-point scale (mild-severe). For example, if the caregiver responds yes to "is the patient resistive to help from others at times, or hard to handle?", the following question would follow: "rate the severity of the symptom". An overall severity summary score is calculated by adding the severity scores of all items, ranging from 0 to 36, and higher scores mean higher severity.
Outcome measures
| Measure |
Alianza Latina
n=65 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Patients' Behavioral Symptoms
|
0.58 Change in units on a scale
Standard Deviation 6.93
|
SECONDARY outcome
Timeframe: Baseline and 6 months from baselinePopulation: Participants responding to these are caregivers on behalf of care recipients or care recipients themselves when possible
Short Geriatric Depression Scale: This scale measures depressive symptomatology, and consists of 15 yes vs no questions. Of the 15 items, 10 indicate the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicate depression when answered negatively. A summary score is obtained ranging from 0 to 15, with higher scores meaning more severe depressive symptomatology.
Outcome measures
| Measure |
Alianza Latina
n=65 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Patients' Depression
|
-0.71 Change in units on a scale
Standard Deviation 3.53
|
SECONDARY outcome
Timeframe: Baseline and 6 months from baselinePopulation: Participants responding to these are caregivers on behalf of care recipients or care recipients themselves when possible
Quality of Life in Alzheimer's Disease: The Quality of Life in Alzheimer's Disease is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better quality of life.
Outcome measures
| Measure |
Alianza Latina
n=65 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Patients' Quality of Life
|
0.42 Change in units on a scale
Standard Deviation 6.07
|
SECONDARY outcome
Timeframe: Baseline and 6 months from baselinePopulation: Participants responding to these are caregivers on their behalf
In general, how satisfied are you with your life?" with a 4-point scale from 1 (Very Satisfied) to 4 (Very Dissatisfied)
Outcome measures
| Measure |
Alianza Latina
n=77 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Caregivers' Quality of Life
|
0.14 Change in units on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Baseline and 6 months from baselinePopulation: Participants responding to these are caregivers on their behalf
10-item Center for Epidemiologic Studies-Depression scale (CES-D-10): This is a 10-item, self-report rating scale that measures characteristic symptoms of depression in the past week (e.g. depression, loneliness, restless sleep). Each item is rated on a 4-point scale, from 0 (rarely or none of the time) to 3 (most or all of the time) with positively worded items (items 5 and 8) reverse scored. Items yield summary scores that range from 0 to 30, with higher scores indicating higher severity. An example of an item is: "I was bothered by things that usually don't bother me"
Outcome measures
| Measure |
Alianza Latina
n=77 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Caregivers' Depression
|
-0.43 Change in units on a scale
Standard Deviation 6.22
|
SECONDARY outcome
Timeframe: Baseline and 6 months from baselinePopulation: Participants responding to these are caregivers on their behalf
Short Zarit Burden Interview: This caregiver burden scale has 6 items that address the perceived impact of the act of providing care on the physical health, emotional health, social activities and financial situation of the caregiver. Each item has five response options ranging from "never" to "nearly always". A total score is obtained by adding scores in all items, with a range from 0 to 24. Higher scores mean higher burden.
Outcome measures
| Measure |
Alianza Latina
n=77 Participants
The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
|
|---|---|
|
Caregivers' Burden
|
0.34 Change in units on a scale
Standard Deviation 4.32
|
Adverse Events
Alianza Latina
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jaime Perales Puchalt
University of Kansas Medical Center
Phone: 913-588-3716
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place