Trial Outcomes & Findings for Support Via Technology: Living and Learning With Advancing FTD (NCT NCT05338710)

NCT ID: NCT05338710

Last Updated: 2025-11-25

Results Overview

The primary outcome variable, reactivity, will be assessed with the RMBPC, which measures the frequency of care recipient behavioral symptoms and care partner reactions to these behaviors. The RMBPC was chosen because it aligns with our theoretical foundation that assumes burden is a result of care partner reactions to behavioral symptoms. The RMBPC is a 29-item caregiver report measure, 5-point Likert scale with frequency measuring from 0 (never occurred) to 4 (daily or more often) and reactivity measuring from 0 (not at all) to 4 (extremely) for a total score between 0-116 for each subscale (frequency subscale and reactivity subscale). Higher scores indicate greater behavioral problems.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)
• Results posted on: 2025-11-25

Participant Flow

We were able to recruit 16 participants

Participant milestones

Measure	Intervention Group There is one intervention group that received the STELLA-FTD intervention. The behavioral intervention was provided to participants and outcomes were measured prior to and after the intervention within the same group.
Overall Study STARTED	16
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Intervention Group There is one intervention group that received the STELLA-FTD intervention. The behavioral intervention was provided to participants and outcomes were measured prior to and after the intervention within the same group.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Support Via Technology: Living and Learning With Advancing FTD

Baseline characteristics by cohort

Measure	Intervention Group n=16 Participants This group received the STELLA-FTD intervention.
Age, Continuous	67.4 years STANDARD_DEVIATION 7.61 • n=45 Participants
Sex: Female, Male Female	12 Participants n=45 Participants
Sex: Female, Male Male	4 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=45 Participants
Race (NIH/OMB) Asian	0 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=45 Participants
Race (NIH/OMB) Black or African American	0 Participants n=45 Participants
Race (NIH/OMB) White	15 Participants n=45 Participants
Race (NIH/OMB) More than one race	0 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=45 Participants
Region of Enrollment United States	16 Participants n=45 Participants
Rural Status Metropolitan	14 Participants n=45 Participants
Rural Status Rural	2 Participants n=45 Participants
Diagnosis of Care Recipient Bv-FTD	7 Participants n=45 Participants
Diagnosis of Care Recipient PPA	7 Participants n=45 Participants
Diagnosis of Care Recipient PSP	1 Participants n=45 Participants
Diagnosis of Care Recipient Unknown	1 Participants n=45 Participants

PRIMARY outcome

Timeframe: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)

Population: thirteen individuals completed this prior to intervention

The primary outcome variable, reactivity, will be assessed with the RMBPC, which measures the frequency of care recipient behavioral symptoms and care partner reactions to these behaviors. The RMBPC was chosen because it aligns with our theoretical foundation that assumes burden is a result of care partner reactions to behavioral symptoms.

The RMBPC is a 29-item caregiver report measure, 5-point Likert scale with frequency measuring from 0 (never occurred) to 4 (daily or more often) and reactivity measuring from 0 (not at all) to 4 (extremely) for a total score between 0-116 for each subscale (frequency subscale and reactivity subscale). Higher scores indicate greater behavioral problems.

Outcome measures

Measure	Intervention Group n=13 Participants received STELLA-FTD
Revised Memory and Behavior Problems Checklist (RMBPC) Pre intervention, behavior frequency	28.5 units on a scale Standard Deviation 15.9
Revised Memory and Behavior Problems Checklist (RMBPC) Post intervention; behavior frequency	25.2 units on a scale Standard Deviation 15.3
Revised Memory and Behavior Problems Checklist (RMBPC) Pre-intervention, reactivity	16.6 units on a scale Standard Deviation 12.9
Revised Memory and Behavior Problems Checklist (RMBPC) Post intervention, reactivity	15.8 units on a scale Standard Deviation 13.5

SECONDARY outcome

Timeframe: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)

Population: Higher scores= better QoL

This is a brief, 13-item measure designed specifically to obtain a rating of the caregiver's Quality of Life. The measure focuses on quality of life domains. It uses simple and straightforward language and responses & includes assessments of the individual's relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality. The total range is 13 to 52 with lower scores indicating worse quality of life.

Outcome measures

Measure	Intervention Group n=13 Participants received STELLA-FTD
Quality of Life Alzheimer's Disease, Care Partner QoL, care partners pre	37.6 units on a scale Standard Deviation 5.06
Quality of Life Alzheimer's Disease, Care Partner QoL, care partners, post	36.2 units on a scale Standard Deviation 3.95

SECONDARY outcome

Timeframe: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)

Measures caregiver self-efficacy for symptoms management and community support service use. Scale 10-100, higher scores indicating better sense of self-efficacy.

Outcome measures

Measure	Intervention Group n=13 Participants received STELLA-FTD
Family Caregiver Self-Efficacy Scale Self-efficacy pre	61.1 units on a scale Standard Deviation 18.8
Family Caregiver Self-Efficacy Scale Self-efficacy post	62.8 units on a scale Standard Deviation 18.3

SECONDARY outcome

Timeframe: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)

Population: Depression assessed prior to and after study

This is a 10-item scale that measures depression; the range is 0 (no depression) to 30 (severe depression).

Outcome measures

Measure	Intervention Group n=13 Participants received STELLA-FTD
Center for Epidemiologic Studies Depression CESD pre	10.8 units on a scale Standard Deviation 5.78
Center for Epidemiologic Studies Depression CESD post	11.3 units on a scale Standard Deviation 6.33

SECONDARY outcome

Timeframe: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)

Population: higher scores=higher grief

Caregiver grief; Scale 18-90, higher scores=worse grief

Outcome measures

Measure	Intervention Group n=13 Participants received STELLA-FTD
Marwit Meuser Caregiver Grief Index MMCGI pre	54.2 units on a scale Standard Deviation 13.7
Marwit Meuser Caregiver Grief Index MMCGI post	55.3 units on a scale Standard Deviation 13.7

SECONDARY outcome

Timeframe: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)

Population: higher scores=greater guilt

The CGQ is a 22-item caregiver report measure, 5-point Likert scale designed to measure guilt in caregivers with response options from 0 (never) to 4 (always or almost always). Items are organized into five main subscales that are scored by computing the sum of the scores of the items belonging to the corresponding scale.

"Guilt about doing wrong by the care recipient" includes 7 items with a score range of 0-28. "Guilt about failing to meet the challenges of caregiving" includes 6 items with item #6 being reverse scored. The score ranges from 0-24. "Guilt about self-care" includes 4 items with a score range of 0-16. "Guilt about neglecting other relatives" includes 2 items with a score range of 0-8. "Guilt about having negative feelings towards other people" includes 3 items with a score range of 0-12.

The total score on the CGQ consists of the sum of the scores of all the subscales, with a total score ranging from 0-88. A higher total score reflects greater guilt.

Outcome measures

Measure	Intervention Group n=13 Participants received STELLA-FTD
Caregiver Guilt Questionnaire (CGQ) Negative feelings towards others pre	2.23 units on a scale Standard Deviation 1.92
Caregiver Guilt Questionnaire (CGQ) Negative feelings post	1.92 units on a scale Standard Deviation 2.43
Caregiver Guilt Questionnaire (CGQ) Neglecting other relatives, pre	2.31 units on a scale Standard Deviation 2.02
Caregiver Guilt Questionnaire (CGQ) Neglecting others post	2.46 units on a scale Standard Deviation 2.63
Caregiver Guilt Questionnaire (CGQ) self care efficacy pre	4.38 units on a scale Standard Deviation 3.8
Caregiver Guilt Questionnaire (CGQ) Self care efficacy post	4.77 units on a scale Standard Deviation 4.21
Caregiver Guilt Questionnaire (CGQ) failing to meet challenges pre	6 units on a scale Standard Deviation 4.6
Caregiver Guilt Questionnaire (CGQ) Failing post	5.85 units on a scale Standard Deviation 4.88
Caregiver Guilt Questionnaire (CGQ) Doing wrong by care recipient pre	9.46 units on a scale Standard Deviation 5.72
Caregiver Guilt Questionnaire (CGQ) Doing wrong post	10.4 units on a scale Standard Deviation 6.24

SECONDARY outcome

Timeframe: Post-Intervention (at Week 8)

Population: Count of items

Caregiver assessment of program

Outcome measures

Measure	Intervention Group n=13 Participants received STELLA-FTD
Experience Survey I feel confident that I can use STELLA-FTD skills to manage upsetting behaviors	13 participants
Experience Survey It was easy for me to attend	13 participants
Experience Survey I could find a safe activity for my family member	13 participants
Experience Survey It was easy to connect via Webex	12 participants
Experience Survey I had good tech support	13 participants
Experience Survey Overall, I was satisfied with the STELLA-FTD experience	13 participants
Experience Survey I could talk openly with the professionals	13 participants
Experience Survey I liked working with other care partners	13 participants
Experience Survey I discuss sensitive topics with other care partners	11 participants

SECONDARY outcome

Timeframe: Pre-Intervention (at Week 1)

The Ten-Item Personality Inventory (TIPI) is a 10-item self-report measure of five personality domains: Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness to Experiences. Each item is rated on a 7-point Likert scale ranging from 1 ("Disagree strongly") to 7 ("Agree strongly"). Items 2, 4, 6, 8, and 10 are reverse-scored.

For this study, items were summed to create a total personality score. Possible total scores range from 10 to 70, with higher scores indicating stronger endorsement of personality characteristics across the five domains (i.e., higher trait expression).

Outcome measures

Measure	Intervention Group n=13 Participants received STELLA-FTD
Ten-Item Personality Inventory (TIPI)	51 units on a scale Standard Deviation 8.73

SECONDARY outcome

Timeframe: Post-Intervention (at Week 8)

The Sleep Hygiene Index (SHI) is a self-administered questionnaire used to assess an individual's sleep hygiene practices. It's a tool used in research and clinical settings to evaluate sleep habits and identify potential areas for improvement. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (always). Total scores range from 0 to 52, with a higher score representing poorer sleep hygiene.

Outcome measures

Measure	Intervention Group n=13 Participants received STELLA-FTD
Sleep Hygiene Index	10.2 units on a scale Standard Deviation 8.66

SECONDARY outcome

Timeframe: Post-Intervention (at Week 8)

A 9-item measure to assess whether caregivers contacted other caregivers or not.

Outcome measures

Measure	Intervention Group n=13 Participants received STELLA-FTD
Contact Survey Number who did not contact other caregivers	11 Participants
Contact Survey Number who contacted others	2 Participants

Adverse Events

Intervention 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

Allison Lindauer, PhD, APRN

OHSU

Phone: 5034944347

Email: lindauer@ohsu.edu

Results disclosure agreements

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