Trial Outcomes & Findings for Standardized Patient-Centered Medication Review in Home Hospice (NCT NCT03972163)
NCT ID: NCT03972163
Last Updated: 2025-05-21
Results Overview
Number of Completed Intervention Trainings
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Baseline
Results posted on
2025-05-21
Participant Flow
Recruitment occurred at two hospice organizations where each hospice organization randomized 1 office to intervention and 1 office to control
Unit of analysis: hospice offices within hospice organizat
Participant milestones
| Measure |
SPECTORx Educational Intervention
The program intervention is based on a combination of 3 existing, complementary, educational programs that, together, equip hospice staff to create a comprehensive, patient-centered, medication management care plan.
STOPPFrail (Screening Tool of Older Persons Prescriptions): A screening tool used by clinicians with frail older adults with life-limiting illness to review medications
"Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing": Education resoruce used by clinicians to simplify and align medications with goals of care
"Key Approaches to Support Informal Family Caregivers in Managing Medications": Education resource used by clinicians to support Family Care Givers (FCGs)
|
Attention Control
As the attention control, we will refer staff in control offices to the National Institute of Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
NIA Medication Management - Active Comparator: As the attention control, we will refer staff in control offices to the National Institution on Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
|
|---|---|---|
|
Overall Study
STARTED
|
7 2
|
16 2
|
|
Overall Study
Hospice 1
|
5 1
|
12 1
|
|
Overall Study
Hospice 2
|
2 1
|
4 1
|
|
Overall Study
COMPLETED
|
7 2
|
15 2
|
|
Overall Study
NOT COMPLETED
|
0 0
|
1 0
|
Reasons for withdrawal
| Measure |
SPECTORx Educational Intervention
The program intervention is based on a combination of 3 existing, complementary, educational programs that, together, equip hospice staff to create a comprehensive, patient-centered, medication management care plan.
STOPPFrail (Screening Tool of Older Persons Prescriptions): A screening tool used by clinicians with frail older adults with life-limiting illness to review medications
"Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing": Education resoruce used by clinicians to simplify and align medications with goals of care
"Key Approaches to Support Informal Family Caregivers in Managing Medications": Education resource used by clinicians to support Family Care Givers (FCGs)
|
Attention Control
As the attention control, we will refer staff in control offices to the National Institute of Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
NIA Medication Management - Active Comparator: As the attention control, we will refer staff in control offices to the National Institution on Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Demographic data for Caregiver Intervention group missing/not available for select participants
Baseline characteristics by cohort
| Measure |
Patients: SPECTORx Educational Intervention
n=7 Participants
The program intervention is based on a combination of 3 existing, complementary, educational programs that, together, equip hospice staff to create a comprehensive, patient-centered, medication management care plan.
STOPPFrail (Screening Tool of Older Persons Prescriptions): A screening tool used by clinicians with frail older adults with life-limiting illness to review medications
"Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing": Education resoruce used by clinicians to simplify and align medications with goals of care
"Key Approaches to Support Informal Family Caregivers in Managing Medications": Education resource used by clinicians to support Family Care Givers (FCGs)
|
Patients: Attention Control
n=15 Participants
As the attention control, we will refer staff in control offices to the National Institute of Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
NIA Medication Management - Active Comparator: As the attention control, we will refer staff in control offices to the National Institution on Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
|
Caregivers SPECTORx Educational Intervention
n=7 Participants
The program intervention is based on a combination of 3 existing, complementary, educational programs that, together, equip hospice staff to create a comprehensive, patient-centered, medication management care plan.
STOPPFrail (Screening Tool of Older Persons Prescriptions): A screening tool used by clinicians with frail older adults with life-limiting illness to review medications
"Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing": Education resoruce used by clinicians to simplify and align medications with goals of care
"Key Approaches to Support Informal Family Caregivers in Managing Medications": Education resource used by clinicians to support Family Care Givers (FCGs)
|
Caregivers: Attention Control
n=15 Participants
As the attention control, we will refer staff in control offices to the National Institute of Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
NIA Medication Management - Active Comparator: As the attention control, we will refer staff in control offices to the National Institution on Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
0 Participants
n=15 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
0 Participants
n=6 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
0 Participants
n=15 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
0 Participants
n=43 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=7 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
0 Participants
n=15 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
3 Participants
n=6 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
8 Participants
n=15 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
11 Participants
n=43 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=7 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
15 Participants
n=15 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
3 Participants
n=6 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
7 Participants
n=15 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
32 Participants
n=43 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
|
Age, Continuous
|
83.6 years
STANDARD_DEVIATION 14.5 • n=7 Participants • Demographic data for Caregiver Intervention group missing/not available.
|
79.5 years
STANDARD_DEVIATION 10.3 • n=15 Participants • Demographic data for Caregiver Intervention group missing/not available.
|
—
|
—
|
80.8 years
STANDARD_DEVIATION 11.6 • n=22 Participants • Demographic data for Caregiver Intervention group missing/not available.
|
|
Sex: Female, Male
Female
|
4 Participants
n=7 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
11 Participants
n=15 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
4 Participants
n=6 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
13 Participants
n=15 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
32 Participants
n=43 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=7 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
4 Participants
n=15 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
2 Participants
n=6 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
2 Participants
n=15 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
11 Participants
n=43 Participants • Demographic data for Caregiver Intervention group missing/not available for select participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
2 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=7 Participants
|
14 Participants
n=15 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=15 Participants
|
41 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=7 Participants
|
13 Participants
n=15 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=15 Participants
|
37 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
2 Participants
n=44 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
15 participants
n=15 Participants
|
7 participants
n=7 Participants
|
15 participants
n=15 Participants
|
22 participants
n=44 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Control group did not offer intervention training.
Number of Completed Intervention Trainings
Outcome measures
| Measure |
SPECTORx Educational Intervention
n=17 Participants
The program intervention is based on a combination of 3 existing, complementary, educational programs that, together, equip hospice staff to create a comprehensive, patient-centered, medication management care plan.
STOPPFrail (Screening Tool of Older Persons Prescriptions): A screening tool used by clinicians with frail older adults with life-limiting illness to review medications
"Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing": Education resoruce used by clinicians to simplify and align medications with goals of care
"Key Approaches to Support Informal Family Caregivers in Managing Medications": Education resource used by clinicians to support Family Care Givers (FCGs)
|
Attention Control
As the attention control, we will refer staff in control offices to the National Institute of Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
NIA Medication Management - Active Comparator: As the attention control, we will refer staff in control offices to the National Institution on Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
|
|---|---|---|
|
Intervention Training Completion by Hospice Staff
|
17 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 weeks prior to enrollmentPopulation: Screened dyads who met eligibility criteria
Number of Eligible Dyad Participants (i.e. participant = 1 dyad) screened for potential eligibility to inform subsequent eligibility criteria to obtain a sufficient study population.
Outcome measures
| Measure |
SPECTORx Educational Intervention
n=77 Dyads
The program intervention is based on a combination of 3 existing, complementary, educational programs that, together, equip hospice staff to create a comprehensive, patient-centered, medication management care plan.
STOPPFrail (Screening Tool of Older Persons Prescriptions): A screening tool used by clinicians with frail older adults with life-limiting illness to review medications
"Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing": Education resoruce used by clinicians to simplify and align medications with goals of care
"Key Approaches to Support Informal Family Caregivers in Managing Medications": Education resource used by clinicians to support Family Care Givers (FCGs)
|
Attention Control
n=184 Dyads
As the attention control, we will refer staff in control offices to the National Institute of Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
NIA Medication Management - Active Comparator: As the attention control, we will refer staff in control offices to the National Institution on Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
|
|---|---|---|
|
Patient and Family Caregiver Eligibility Screens
|
77 Dyads
|
184 Dyads
|
PRIMARY outcome
Timeframe: BaselinePopulation: number of participants who consented to enrollment and survived to data collection; 1 patient died before data collection so dyad was removed
Number of Patients and Family Caregivers who enrolled
Outcome measures
| Measure |
SPECTORx Educational Intervention
n=7 Dyads
The program intervention is based on a combination of 3 existing, complementary, educational programs that, together, equip hospice staff to create a comprehensive, patient-centered, medication management care plan.
STOPPFrail (Screening Tool of Older Persons Prescriptions): A screening tool used by clinicians with frail older adults with life-limiting illness to review medications
"Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing": Education resoruce used by clinicians to simplify and align medications with goals of care
"Key Approaches to Support Informal Family Caregivers in Managing Medications": Education resource used by clinicians to support Family Care Givers (FCGs)
|
Attention Control
n=15 Dyads
As the attention control, we will refer staff in control offices to the National Institute of Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
NIA Medication Management - Active Comparator: As the attention control, we will refer staff in control offices to the National Institution on Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
|
|---|---|---|
|
Patient and Family Caregiver Enrollment
|
7 Dyads
|
15 Dyads
|
PRIMARY outcome
Timeframe: BaselinePopulation: number of participants who consented to enrollment and survived to data collection; 1 patient died before data collection so dyad was removed
Number of Dyads who completed the Medication Regimen Complexity Score at Baseline
Outcome measures
| Measure |
SPECTORx Educational Intervention
n=7 Dyads
The program intervention is based on a combination of 3 existing, complementary, educational programs that, together, equip hospice staff to create a comprehensive, patient-centered, medication management care plan.
STOPPFrail (Screening Tool of Older Persons Prescriptions): A screening tool used by clinicians with frail older adults with life-limiting illness to review medications
"Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing": Education resoruce used by clinicians to simplify and align medications with goals of care
"Key Approaches to Support Informal Family Caregivers in Managing Medications": Education resource used by clinicians to support Family Care Givers (FCGs)
|
Attention Control
n=15 Dyads
As the attention control, we will refer staff in control offices to the National Institute of Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
NIA Medication Management - Active Comparator: As the attention control, we will refer staff in control offices to the National Institution on Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
|
|---|---|---|
|
Completion of Primary Patient Outcome--Retention
|
7 Dyads
|
15 Dyads
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 6, 8 12, 16, 20, 24 weeks(or death)Population: number of participants who consented to enrollment and survived to data collection; 1 patient died before data collection so dyad was removed
The 24-item Family Caregiver Medication Administration Hassle Scale has four subscales: Information Seeking/Sharing, Safety Issues, Scheduling Logistics, and Polypharmacy. The theoretical range of the scores across 4 subscales is 0 to 120. Higher scores indicate greater burden. Overall scale reliability is .95.
Outcome measures
| Measure |
SPECTORx Educational Intervention
n=7 Participants
The program intervention is based on a combination of 3 existing, complementary, educational programs that, together, equip hospice staff to create a comprehensive, patient-centered, medication management care plan.
STOPPFrail (Screening Tool of Older Persons Prescriptions): A screening tool used by clinicians with frail older adults with life-limiting illness to review medications
"Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing": Education resoruce used by clinicians to simplify and align medications with goals of care
"Key Approaches to Support Informal Family Caregivers in Managing Medications": Education resource used by clinicians to support Family Care Givers (FCGs)
|
Attention Control
n=15 Participants
As the attention control, we will refer staff in control offices to the National Institute of Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
NIA Medication Management - Active Comparator: As the attention control, we will refer staff in control offices to the National Institution on Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
|
|---|---|---|
|
Family Caregiver Medication Administration Hassle Scale
12 weeks
|
10 score on a scale
|
33.3 score on a scale
Standard Deviation 3.9
|
|
Family Caregiver Medication Administration Hassle Scale
16 weeks
|
7 score on a scale
|
30 score on a scale
|
|
Family Caregiver Medication Administration Hassle Scale
6 weeks
|
22.5 score on a scale
Standard Deviation 13.4
|
26.8 score on a scale
Standard Deviation 12.2
|
|
Family Caregiver Medication Administration Hassle Scale
Baseline
|
13.6 score on a scale
Standard Deviation 21.1
|
31 score on a scale
Standard Deviation 16.7
|
|
Family Caregiver Medication Administration Hassle Scale
2 weeks
|
19.7 score on a scale
Standard Deviation 30.6
|
37 score on a scale
Standard Deviation 17.5
|
|
Family Caregiver Medication Administration Hassle Scale
4 weeks
|
16.7 score on a scale
Standard Deviation 19.5
|
36.1 score on a scale
Standard Deviation 17.5
|
|
Family Caregiver Medication Administration Hassle Scale
8 weeks
|
21.5 score on a scale
Standard Deviation 23.3
|
26.5 score on a scale
Standard Deviation 9.5
|
|
Family Caregiver Medication Administration Hassle Scale
20 weeks
|
—
|
47 score on a scale
|
|
Family Caregiver Medication Administration Hassle Scale
24 weeks (or death)
|
—
|
21 score on a scale
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks(or death)Population: number of participants who consented to enrollment and survived to data collection; 1 patient died before data collection so dyad was removed
Medication Regimen Complexity Index (MCRI) will characterize patients' chronic disease and preventive medication regimens (i.e. drugs initiated prior to hospice admission, not End of Life (EOL) symptom medications \[e.g. haloperidol\] because these increase over time). MRCI score weights dosage form, dosing frequency and administration instructions. Minimum MRCI is 1.5 \[a single tablet once a day\] and maximum score increases with medication number. Higher scores indicate greater complexity. MRCI score of 0 indicates no medication use. There is no established maximum score.
Outcome measures
| Measure |
SPECTORx Educational Intervention
n=7 Participants
The program intervention is based on a combination of 3 existing, complementary, educational programs that, together, equip hospice staff to create a comprehensive, patient-centered, medication management care plan.
STOPPFrail (Screening Tool of Older Persons Prescriptions): A screening tool used by clinicians with frail older adults with life-limiting illness to review medications
"Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing": Education resoruce used by clinicians to simplify and align medications with goals of care
"Key Approaches to Support Informal Family Caregivers in Managing Medications": Education resource used by clinicians to support Family Care Givers (FCGs)
|
Attention Control
n=15 Participants
As the attention control, we will refer staff in control offices to the National Institute of Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
NIA Medication Management - Active Comparator: As the attention control, we will refer staff in control offices to the National Institution on Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
|
|---|---|---|
|
Medication Regimen Complexity Index
baseline
|
39 score on a scale
Standard Deviation 8.8
|
23.5 score on a scale
Standard Deviation 8.2
|
|
Medication Regimen Complexity Index
2 weeks
|
43.5 score on a scale
Standard Deviation 13.1
|
31.0 score on a scale
Standard Deviation 10.3
|
|
Medication Regimen Complexity Index
4 weeks
|
43.3 score on a scale
Standard Deviation 12.9
|
32.5 score on a scale
Standard Deviation 11.2
|
|
Medication Regimen Complexity Index
6 weeks
|
46.4 score on a scale
Standard Deviation 13.9
|
33.6 score on a scale
Standard Deviation 12.8
|
|
Medication Regimen Complexity Index
8 weeks
|
44 score on a scale
Standard Deviation 19.4
|
31.1 score on a scale
Standard Deviation 12.4
|
|
Medication Regimen Complexity Index
12 weeks
|
43.8 score on a scale
Standard Deviation 21.1
|
26.8 score on a scale
Standard Deviation 12.5
|
|
Medication Regimen Complexity Index
16 weeks
|
51.1 score on a scale
Standard Deviation 11.3
|
29 score on a scale
Standard Deviation 15.2
|
|
Medication Regimen Complexity Index
20 weeks
|
52.3 score on a scale
Standard Deviation 12.3
|
33.4 score on a scale
Standard Deviation 15.0
|
|
Medication Regimen Complexity Index
24 weeks (or death)
|
47 score on a scale
Standard Deviation 16.9
|
23.5 score on a scale
Standard Deviation 22.6
|
SECONDARY outcome
Timeframe: Week 2, 4, 6, 8, 12, 16, 20, 24Population: Data on Potential Adverse Drug Events for patient participants
Hospitalizations and Emergency Department (ED) visits will be abstracted from the hospice record. Potential Adverse Drug Event (ADE)s and Adverse Drug Withdrawal Events (ADWEs) will be determined from medical record review
Outcome measures
| Measure |
SPECTORx Educational Intervention
n=7 Participants
The program intervention is based on a combination of 3 existing, complementary, educational programs that, together, equip hospice staff to create a comprehensive, patient-centered, medication management care plan.
STOPPFrail (Screening Tool of Older Persons Prescriptions): A screening tool used by clinicians with frail older adults with life-limiting illness to review medications
"Discontinuing Medication Appropriately" and "Understanding the Art of Communication about Deprescribing": Education resoruce used by clinicians to simplify and align medications with goals of care
"Key Approaches to Support Informal Family Caregivers in Managing Medications": Education resource used by clinicians to support Family Care Givers (FCGs)
|
Attention Control
n=15 Participants
As the attention control, we will refer staff in control offices to the National Institute of Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
NIA Medication Management - Active Comparator: As the attention control, we will refer staff in control offices to the National Institution on Aging (NIA)'s website on "Medicines and Medication Management" to review content and materials for use in Family Care Giver (FCG) support.
|
|---|---|---|
|
Potential Adverse Event
Baseline
|
0 Adverse Events
|
0 Adverse Events
|
|
Potential Adverse Event
Week 2
|
0 Adverse Events
|
0 Adverse Events
|
|
Potential Adverse Event
Week 4
|
0 Adverse Events
|
0 Adverse Events
|
|
Potential Adverse Event
Week 6
|
0 Adverse Events
|
0 Adverse Events
|
|
Potential Adverse Event
week 8
|
0 Adverse Events
|
0 Adverse Events
|
|
Potential Adverse Event
Week 12
|
0 Adverse Events
|
0 Adverse Events
|
|
Potential Adverse Event
Week 16
|
0 Adverse Events
|
0 Adverse Events
|
|
Potential Adverse Event
Week 20
|
0 Adverse Events
|
0 Adverse Events
|
|
Potential Adverse Event
Week 24
|
0 Adverse Events
|
0 Adverse Events
|
Adverse Events
Patients: SPECTORx Educational Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Patients: Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 10 deaths
Family Caregivers: SPECTORx Educational Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Family Caregivers: Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jennifer Tjia, Principal Investigator
UMass Chan Medical School
Phone: 774-455-3538
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place