Trial Outcomes & Findings for SUPPORT-D Intervention for Persons With Alzheimer's Disease and Their Caregivers (NCT NCT05501119)

NCT ID: NCT05501119

Last Updated: 2025-04-08

Results Overview

30 items (T/F) summed total of correct items higher score indicates higher knowledge (scores range from 0-30)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

baseline, at study completion, an average of 8 weeks

Results posted on

2025-04-08

Participant Flow

Participant milestones

Participant milestones
Measure
Intervention Group
Number of dyads or individual caregivers who received SUPPORT-D Intervention
Overall Study
STARTED
30
Overall Study
COMPLETED
23
Overall Study
NOT COMPLETED
7

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention Group
Number of dyads or individual caregivers who received SUPPORT-D Intervention
Overall Study
Withdrawal by Subject
2
Overall Study
Lost to Follow-up
5

Baseline Characteristics

Row population differs from overall due to participants not completing all survey items.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Caregiver Group
n=29 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Care Recipient Group
n=27 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Total
n=56 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=29 Participants
0 Participants
n=27 Participants
0 Participants
n=56 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=29 Participants
6 Participants
n=27 Participants
7 Participants
n=56 Participants
Age, Categorical
>=65 years
28 Participants
n=29 Participants
21 Participants
n=27 Participants
49 Participants
n=56 Participants
Age, Continuous
69.5 years
STANDARD_DEVIATION 10.3 • n=29 Participants
75.1 years
STANDARD_DEVIATION 8.3 • n=27 Participants
72.4 years
STANDARD_DEVIATION 9.6 • n=56 Participants
Sex: Female, Male
Female
23 Participants
n=29 Participants
8 Participants
n=27 Participants
31 Participants
n=56 Participants
Sex: Female, Male
Male
6 Participants
n=29 Participants
19 Participants
n=27 Participants
25 Participants
n=56 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=29 Participants
2 Participants
n=27 Participants
4 Participants
n=56 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
27 Participants
n=29 Participants
25 Participants
n=27 Participants
52 Participants
n=56 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=29 Participants
0 Participants
n=27 Participants
0 Participants
n=56 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=29 Participants
0 Participants
n=27 Participants
0 Participants
n=56 Participants
Race (NIH/OMB)
Asian
0 Participants
n=29 Participants
0 Participants
n=27 Participants
0 Participants
n=56 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=29 Participants
0 Participants
n=27 Participants
0 Participants
n=56 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=29 Participants
1 Participants
n=27 Participants
4 Participants
n=56 Participants
Race (NIH/OMB)
White
25 Participants
n=29 Participants
26 Participants
n=27 Participants
51 Participants
n=56 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=29 Participants
0 Participants
n=27 Participants
1 Participants
n=56 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=29 Participants
0 Participants
n=27 Participants
0 Participants
n=56 Participants
Region of Enrollment
United States
29 participants
n=29 Participants
27 participants
n=27 Participants
56 participants
n=56 Participants
Alzheimer's Disease Knowledge Scale
25.18 units on a scale
STANDARD_DEVIATION 2.45 • n=29 Participants
20.36 units on a scale
STANDARD_DEVIATION 5.38 • n=27 Participants
23.1 units on a scale
STANDARD_DEVIATION 2.27 • n=56 Participants
Perceived Stress Scale
20.50 units on a scale
STANDARD_DEVIATION 4.51 • n=28 Participants • Row population differs from overall due to participants not completing all survey items.
16.18 units on a scale
STANDARD_DEVIATION 5.91 • n=23 Participants • Row population differs from overall due to participants not completing all survey items.
18.3 units on a scale
STANDARD_DEVIATION 5.31 • n=51 Participants • Row population differs from overall due to participants not completing all survey items.
Quality of Life in Alzheimer's Disease Scale
34.61 units on a scale
STANDARD_DEVIATION 7.26 • n=28 Participants • Row population differs from overall sample due to participants not completing all survey items.
39.23 units on a scale
STANDARD_DEVIATION 7.35 • n=22 Participants • Row population differs from overall sample due to participants not completing all survey items.
36.64 units on a scale
STANDARD_DEVIATION 7.59 • n=50 Participants • Row population differs from overall sample due to participants not completing all survey items.
Caregiver Self-efficacy Scale
6.67 units on a scale
STANDARD_DEVIATION 1.70 • n=28 Participants • This is a caregiver only measure care recipients not assessed for this measure. Row total may differ from overall population due to participants not completing all survey items.
6.67 units on a scale
STANDARD_DEVIATION 1.70 • n=28 Participants • This is a caregiver only measure care recipients not assessed for this measure. Row total may differ from overall population due to participants not completing all survey items.
Safety Assessment Scale
30.32 units on a scale
STANDARD_DEVIATION 5.98 • n=28 Participants • This is a caregiver measure only, care recipients not assessed. Row total may differ from overall sample due to participants not completing all survey items.
30.32 units on a scale
STANDARD_DEVIATION 5.98 • n=28 Participants • This is a caregiver measure only, care recipients not assessed. Row total may differ from overall sample due to participants not completing all survey items.
Zarit Burden Interview
18.21 units on a scale
STANDARD_DEVIATION 9.19 • n=28 Participants • This is a caregiver only measure, care recipient not assessed. Row total may differ from overall sample due to participants not completing all survey items.
18.21 units on a scale
STANDARD_DEVIATION 9.19 • n=28 Participants • This is a caregiver only measure, care recipient not assessed. Row total may differ from overall sample due to participants not completing all survey items.

PRIMARY outcome

Timeframe: baseline, at study completion, an average of 8 weeks

30 items (T/F) summed total of correct items higher score indicates higher knowledge (scores range from 0-30)

Outcome measures

Outcome measures
Measure
Caregiver Group
n=23 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Care Recipient Group
n=13 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Change in Alzheimer's Disease Knowledge Scale (ADKS) Score
0.26 score on a scale
Standard Deviation 1.74
1.15 score on a scale
Standard Deviation 3.80

PRIMARY outcome

Timeframe: at study completion, an average of 8 weeks

4 items (5 point Likert scale) average score across items higher score indicates more acceptability of intervention (raw score ranges from 4-20)

Outcome measures

Outcome measures
Measure
Caregiver Group
n=23 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Care Recipient Group
n=11 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Acceptability of Intervention Measure (AIM) Score
4.36 score on a scale
Standard Deviation 0.5
3.51 score on a scale
Standard Deviation 1.18

PRIMARY outcome

Timeframe: at study completion, an average of 8 weeks

4 items (5 point Likert scale) average score across items higher score indicates greater feasibility of intervention (raw scores range from 4-20)

Outcome measures

Outcome measures
Measure
Caregiver Group
n=23 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Care Recipient Group
n=11 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Feasibility Score
4.24 score on a scale
Standard Deviation 0.70
4.05 score on a scale
Standard Deviation 0.75

PRIMARY outcome

Timeframe: baseline, at study completion, an average of 8 weeks

12 items (5 point Likert scale (0-4)) summed score with higher scores indicating greater caregiver distress (raw scores range from 0-48)

Outcome measures

Outcome measures
Measure
Caregiver Group
n=23 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Care Recipient Group
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Change Zarit Caregiver Burden Score
-1.09 score on a scale
Standard Deviation 5.02

PRIMARY outcome

Timeframe: baseline and at study completion, an average of 8 weeks

10 items (4 point Likert scale ranging from 0-4) summed score across items with higher scores indicate greater levels of stress (scores range from 0-40)

Outcome measures

Outcome measures
Measure
Caregiver Group
n=28 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Care Recipient Group
n=13 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Change in Perceived Stress Scale Score
-0.09 score on a scale
Standard Deviation 3.18
1.38 score on a scale
Standard Deviation 6.93

PRIMARY outcome

Timeframe: baseline and at study completion, an average of 8 weeks

13 items (4 point Likert scale ranging from 1-4) summed score across items with higher scores indicating better quality of life (scores range from 13-52)

Outcome measures

Outcome measures
Measure
Caregiver Group
n=28 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Care Recipient Group
n=23 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Change in Quality of Life-Alzheimer's Disease (QoL-AD) Score
-0.74 score on a scale
Standard Error 3.73
-0.08 score on a scale
Standard Error 6.40

PRIMARY outcome

Timeframe: baseline and at study completion, an average of 8 weeks

8 items rated from 1-10 mean score across items with higher scores indicating higher self-efficacy (raw scores range from 8-80)

Outcome measures

Outcome measures
Measure
Caregiver Group
n=23 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Care Recipient Group
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Change in Self-efficacy for Caregiving Score
0.54 score on a scale
Standard Deviation 1.02

PRIMARY outcome

Timeframe: baseline and at study completion, an average of 8 weeks

16 items with response options ranging from 0 to 4. The minimum score is 0, indicating no safety concerns, while the maximum score is 64, indicating significant safety risks.

Outcome measures

Outcome measures
Measure
Caregiver Group
n=23 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Care Recipient Group
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Change in Safety Assessment Scale Score
0.09 score on a scale
Standard Deviation 4.17

PRIMARY outcome

Timeframe: at study completion, an average of 8 weeks

4 items (5 point Likert scale) average score across items higher score indicates greater appropriateness of intervention (scores range from 4-20)

Outcome measures

Outcome measures
Measure
Caregiver Group
n=23 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Care Recipient Group
n=13 Participants
A Program of SUPPORT-D (dementia): The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
Appropriateness of Intervention Score
4.33 units on a scale
Standard Deviation 0.58
4.05 units on a scale
Standard Deviation 0.71

Adverse Events

SUPPORT-D Caregiver Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

SUPPORT-D Care Recipient Group

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. Diana Layne

Medical University of South Carolina

Phone: (843) 792-8515

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place