Trial Outcomes & Findings for Supporting Family Caregivers With Technology for Dementia Home Care (NCT NCT02483520)

Last Updated: 2020-11-13

Results Overview

Behavioral coding of videos for agitated, disruptive, or resistive behaviors will be used to identity changes in behavior before and after the intervention.

Recruitment status

COMPLETED

Study phase

Target enrollment

189 participants

Primary outcome timeframe

3 months

Results posted on

2020-11-13

Participant Flow

Site A participants were recruited by advertisements in local media, university email, and regional conferences for caregivers. Site B participants were primarily recruited through an Alzheimer Disease center, a memory care clinic, and community outreach activities.

Caregiver-Person with Dementia (PWD) dyads were randomly assigned to the intervention (FamTechCare) group or the attention control group using a quarter-based blocking strategy with 1:1 allocation developed by the study statistician. Caregivers in multiple dyad homes were cluster randomized to the same group.

Participant milestones

Participant milestones
Measure	Intervention FamTechCare This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Overall Study STARTED	92	97
Overall Study Caregivers	50	56
Overall Study Persons With Dementia	42	41
Overall Study COMPLETED	81	73
Overall Study NOT COMPLETED	11	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention FamTechCare This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Overall Study Lost to Follow-up	3	4
Overall Study Withdrawal by Subject	4	14
Overall Study Hospitalized	2	3
Overall Study Moved to LTC	2	3

Baseline Characteristics

Caregivers and Persons with Dementia reported. Combined they equal total participants.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 3 months

Population: Over 3 months, caregivers recorded videos during challenging care situations in order to receive feedback on interventions. Behavioral coding of the videos was not possible due to lack of consistent content post intervention. Caregivers failed to record follow-up videos of the care situations when they were no longer challenging.

Behavioral coding of videos for agitated, disruptive, or resistive behaviors will be used to identity changes in behavior before and after the intervention.

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=81 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=73 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Change in Behaviorally Coded Challenging Behaviors (Agitated, Disruptive, Resistive)	784 Care videos submitted	253 Care videos submitted

PRIMARY outcome

Timeframe: Baseline, 1 month, 3 months

Population: One caregiver is missing from the control group due to missing data (missing at random).

Caregiver reaction to behavioral symptoms of the Person with Dementia (PWD) was measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items, each with two parts. Each item represents a behavior; if the behavior has been exhibited by the PWD in the past week, the caregiver reports the behavior as present. If the behavior is present, the caregiver then reports "how much it bothered you?" on a five-point Likert scale (0 = not at all; 4 = extremely). If the behavior was not present, no "bother" score is provided, and the item is scored 0. The items are summed for a total score (range = 0-96) and for three subscales representing bother due to memory-related problems (range = 0-28), depressive symptoms (range = 0-36), and disruptive symptoms (range = 0-32). A higher score indicates a greater negative reaction to behaviors.

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=42 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=40 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Change in Caregiver Stress - Reaction to Memory Symptoms (Bother) Baseline	22.8 score on a scale Standard Deviation 15.6	17.5 score on a scale Standard Deviation 11.8
Change in Caregiver Stress - Reaction to Memory Symptoms (Bother) 1 month	20.5 score on a scale Standard Deviation 14.3	18.9 score on a scale Standard Deviation 13.0
Change in Caregiver Stress - Reaction to Memory Symptoms (Bother) 3 months	19.8 score on a scale Standard Deviation 15.3	17.4 score on a scale Standard Deviation 12.6

PRIMARY outcome

Timeframe: Baseline, 1 month, 3 months

Population: One caregiver is missing from the control group due to missing data (missing at random).

Caregiver reaction to behavioral symptoms of the person with dementia (PWD) was measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items, each with two parts. Each item represents a behavior; if the behavior has been exhibited by the PWD in the past week, the caregiver reports the behavior as present. If the behavior is present, the caregiver then reports "how much it bothered you?" on a five-point Likert scale (0 = not at all; 4 = extremely). If the behavior was not present, no "bother" score is provided, and the item is scored 0. The items are summed for a total score (range = 0-96) and for three subscales representing bother due to memory-related problems (range = 0-28), depressive symptoms (range = 0-36), and disruptive symptoms (range = 0-32). A higher score indicates a greater negative reaction to behaviors.

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=42 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=40 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Change in Caregiver Stress - Reaction to Depressive Symptoms (Bother) Baseline	8.3 score on a scale Standard Deviation 7.3	6.9 score on a scale Standard Deviation 6.8
Change in Caregiver Stress - Reaction to Depressive Symptoms (Bother) 1 month	6.8 score on a scale Standard Deviation 7.6	7.6 score on a scale Standard Deviation 6.9
Change in Caregiver Stress - Reaction to Depressive Symptoms (Bother) 3 months	7.3 score on a scale Standard Deviation 7.0	6.1 score on a scale Standard Deviation 6.6

PRIMARY outcome

Timeframe: Baseline, 1 month, 3 months

Desire to institutionalize was measured using a modified Desire to Institutionalize Scale. The modified Desire to Institutionalize Scale contains six items rated as dichotomous yes or no (1 = yes; 0 = no). A higher score indicates a greater desire to institutionalize (range = 0-6). Internal consistency for the Desire to Institutionalize scale is adequate (α = .69-.77) and has shown adequate construct validity through factor analysis.

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=42 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=41 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Change in Caregiver Stress - Desire to Instituionalize Baseline	1.5 score on a scale Standard Deviation 1.7	1.7 score on a scale Standard Deviation 1.5
Change in Caregiver Stress - Desire to Instituionalize 1 month	1.6 score on a scale Standard Deviation 1.7	1.9 score on a scale Standard Deviation 2.1
Change in Caregiver Stress - Desire to Instituionalize 3 months	2.0 score on a scale Standard Deviation 2.0	2.5 score on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: Baseline, 1 month, 3 months

Population: Unable to collect information due to feasibility. Sensors were unreliable. Two different types of sensors were attempted.

Biological stress reactions measured by sensor

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 1 month, 3 months

Caregiver burden was measured using the Modified Zarit Burden Scale that contains 12 items with a 5-point Likert scale (0 = never; 4 = nearly always) adapted from the 22-item Zarit Burden Interview. A higher score indicates greater caregiver burden (range = 0-48). The Modified Zarit Burden Scale has shown adequate internal consistency (α = .88) and excellent concurrent validity (r = .92- .97) with the full Zarit Burden Interview.

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=42 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=41 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Change in Caregiver Burden 3 months	26.6 score on a scale Standard Deviation 9.8	27.4 score on a scale Standard Deviation 9.1
Change in Caregiver Burden Baseline	28.0 score on a scale Standard Deviation 10.6	27.2 score on a scale Standard Deviation 8.1
Change in Caregiver Burden 1 month	27.6 score on a scale Standard Deviation 9.9	26.6 score on a scale Standard Deviation 8.5

PRIMARY outcome

Timeframe: Baseline, 1 month, 3 months

Caregiver depression was measured using the Center for Epidemiologic Studies Depression scale (CES-D). The CES-D contains 20 items with a 4-point Likert scale ranging from 0 = rarely or none of the time (i.e., less than 1 day in past week) to 3 = most or all of the time (i.e., 5-7 days in past week). A higher score indicates greater depression (range = 0-60). The CES-D shows adequate internal consistency (α = .84-.90), moderate convergent validity with other depression scales (r = .44-.75), and has been shown to effectively measure change in psychoeducational interventions for dementia caregivers.

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=42 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=41 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Change in Caregiver Health and Wellbeing - Depression Baseline	16.0 score on a scale Standard Deviation 10.7	12.0 score on a scale Standard Deviation 8.1
Change in Caregiver Health and Wellbeing - Depression 1 month	14.5 score on a scale Standard Deviation 11.9	12.8 score on a scale Standard Deviation 10.2
Change in Caregiver Health and Wellbeing - Depression 3 months	13.8 score on a scale Standard Deviation 10.6	12.3 score on a scale Standard Deviation 10.8

PRIMARY outcome

Timeframe: Baseline, 1 month, 3 months

Caregiver sense of competence was measured using the Short Sense of Competence Questionnaire (SSCQ).37 The SSCQ contains seven negatively worded items (e.g., "I feel strained in my interaction with..."). Each item is rated on a five-point Likert scale and dichotomized to agree (i.e., agree very strongly, agree, neutral) or disagree (i.e., disagree or strongly disagree). The items where the caregiver disagreed are summed for the total score. A higher score indicates a higher sense of competence (range = 0-7). The SSCQ shows adequate internal consistency (α = .76) and concurrent validity with the original Sense of Competence Questionnaire (r = .88).

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=42 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=41 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Change in Caregiver Health and Wellbeing - Competence Baseline	3.7 score on a scale Standard Deviation 1.8	3.9 score on a scale Standard Deviation 2.2
Change in Caregiver Health and Wellbeing - Competence 1 month	4.0 score on a scale Standard Deviation 2.0	3.8 score on a scale Standard Deviation 2.1
Change in Caregiver Health and Wellbeing - Competence 3 months	4.1 score on a scale Standard Deviation 1.9	3.5 score on a scale Standard Deviation 2.2

PRIMARY outcome

Timeframe: Baseline, 1 month, 3 months

Caregiver sleep disturbance was measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI contains 19 items with a 4-point Likert scale across seven domains: sleep quality, sleep latency, sleep duration, habitual sleep ef- ficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. A higher global score indicates worse sleep quality (range = 0-21). The PSQI shows adequate internal consistency (α = .83) and adequate validity in differentiating patients with and without sleep disorders.

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=42 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=41 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Change in Caregiver Health and Wellbeing - Sleep Disturbance Baseline	7.5 score on a scale Standard Deviation 3.5	7.0 score on a scale Standard Deviation 3.5
Change in Caregiver Health and Wellbeing - Sleep Disturbance 1 month	7.3 score on a scale Standard Deviation 3.6	6.9 score on a scale Standard Deviation 3.8
Change in Caregiver Health and Wellbeing - Sleep Disturbance 3 months	7.3 score on a scale Standard Deviation 3.4	6.8 score on a scale Standard Deviation 4.2

PRIMARY outcome

Timeframe: Baseline, 1 month, 3 months

Population: We used descriptive statistics to describe changes in caregiver medication use between groups.

Caregivers taking PRN anxiolytics, hypnotics, or antipsychotic medication.

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=2 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=4 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Change in Caregiver Health and Wellbeing - Medication Use 1 month	2 Participants	3 Participants
Change in Caregiver Health and Wellbeing - Medication Use 3 months	1 Participants	3 Participants
Change in Caregiver Health and Wellbeing - Medication Use Baseline	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: Six caregivers were missing data on this measure and were not used in the analysis.

Caregivers reported their three priority care challenges at baseline using the Caregiver Target Problems Questionnaire (Teri, McCurry, Logsdon, \& Gibbons, 2005). The Caregiver Target Problems Questionnaire was adapted and used to identify caregiver priority care challenges for frequency, severity, and confidence at baseline and 3-months (Teri et al., 2005). Prior to group allocation, caregivers identified three priority care challenges and rated them on 5-point Likert scales: frequency of the challenge (0 = None to 4 = Daily or more often), severity of the challenge (0 = Trivial to 4 = Severe), and confidence in managing the challenge (0 = Unable to manage to 4 = Very confident). At the end of the 3-month trial, caregivers repeated their ratings of the baseline care challenges. Improvement was indicated increase in confidence from baseline to 3-months.

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=42 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=35 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Change in Caregiver Health and Wellbeing - Confidence in Managing BPSD Baseline	1.7 score on a scale Standard Deviation 1.1	2.3 score on a scale Standard Deviation 1.0
Change in Caregiver Health and Wellbeing - Confidence in Managing BPSD 3 months	2.6 score on a scale Standard Deviation 1.1	2.8 score on a scale Standard Deviation 1.0

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: Twenty-three caregivers were missing data on this measure and were not used in the analysis.

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=29 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=31 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Change in Caregiver Health and Wellbeing - Confidence in Managing Disease Expectations Baseline	2.3 score on a scale Standard Deviation 0.9	2.2 score on a scale Standard Deviation 1.0
Change in Caregiver Health and Wellbeing - Confidence in Managing Disease Expectations 3 months	2.9 score on a scale Standard Deviation 1.2	2.8 score on a scale Standard Deviation 0.7

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: Forty-one caregivers were missing data on this measure and were not used in the analysis.

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=18 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=24 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Change in Caregiver Health and Wellbeing - Confidence in Managing ADLs (Activities of Daily Living) Baseline	2.3 score on a scale Standard Deviation 1.0	2.2 score on a scale Standard Deviation 1.1
Change in Caregiver Health and Wellbeing - Confidence in Managing ADLs (Activities of Daily Living) 3 months	2.8 score on a scale Standard Deviation 0.9	2.6 score on a scale Standard Deviation 0.9

PRIMARY outcome

Timeframe: Baseline, 1 month, 3 months

Population: One caregiver is missing from the control group due to missing data (missing at random).

Caregiver reaction to behavioral symptoms of the PLWD was measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items, each with two parts. Each item represents a behavior; if the behavior has been exhibited by the PLWD in the past week, the caregiver reports the behavior as present. If the behavior is present, the caregiver then reports "how much it bothered you?" on a five-point Likert scale (0 = not at all; 4 = extremely). If the behavior was not present, no "bother" score is provided, and the item is scored 0. The items are summed for a total score (range = 0-96) and for three subscales representing bother due to memory-related problems (range = 0-28), depressive symptoms (range = 0-36), and disruptive symptoms (range = 0-32). A higher score indicates a greater negative reaction to behaviors.

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=42 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=40 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Change in Caregiver Reported Challenging Behaviors - Reaction to Disruptive Symptoms (Bother) Baseline	6.1 score on a scale Standard Deviation 5.7	4.0 score on a scale Standard Deviation 4.2
Change in Caregiver Reported Challenging Behaviors - Reaction to Disruptive Symptoms (Bother) 1 month	5.3 score on a scale Standard Deviation 4.7	5.1 score on a scale Standard Deviation 4.9
Change in Caregiver Reported Challenging Behaviors - Reaction to Disruptive Symptoms (Bother) 3 months	5.4 score on a scale Standard Deviation 5.4	4.9 score on a scale Standard Deviation 5.0

PRIMARY outcome

Timeframe: Baseline, 1 month, 3 months

Frequency of disruptive behaviors measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items. Each item represents a behavior; if the behavior has been exhibited by the person with dementia in the past week, the caregiver reports the behavior as present. There are 8 disruptive behaviors questions. Range is 0-8. A decrease in disruptive behaviors is an improvement.

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=42 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=41 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Change in Caregiver Reported Challenging Behaviors - Frequency of Disruptive Behaviors Baseline	2.40 score on a scale Standard Deviation 1.85	1.88 score on a scale Standard Deviation 1.68
Change in Caregiver Reported Challenging Behaviors - Frequency of Disruptive Behaviors 1 month	2.45 score on a scale Standard Deviation 1.88	2.39 score on a scale Standard Deviation 1.91
Change in Caregiver Reported Challenging Behaviors - Frequency of Disruptive Behaviors 3 months	2.40 score on a scale Standard Deviation 1.89	2.29 score on a scale Standard Deviation 1.78

SECONDARY outcome

Timeframe: 3 months

Population: 3 month cost

Process-based costing for the FamTechCare group compared to the control group. Costs reflect the total cost for the program per dyad per week.

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=81 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=73 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Cost for FamTechCare Treatment Compared to Control Group Video-monitoring unit	175.00 US Dollars/Dyad/Week	0 US Dollars/Dyad/Week
Cost for FamTechCare Treatment Compared to Control Group Expert Team	174.16 US Dollars/Dyad/Week	0 US Dollars/Dyad/Week
Cost for FamTechCare Treatment Compared to Control Group Interventionist feedback call	86.63 US Dollars/Dyad/Week	76.02 US Dollars/Dyad/Week
Cost for FamTechCare Treatment Compared to Control Group Video screening	65.69 US Dollars/Dyad/Week	7.54 US Dollars/Dyad/Week
Cost for FamTechCare Treatment Compared to Control Group Mail	49.22 US Dollars/Dyad/Week	0 US Dollars/Dyad/Week
Cost for FamTechCare Treatment Compared to Control Group Enrollment	30.37 US Dollars/Dyad/Week	0 US Dollars/Dyad/Week

SECONDARY outcome

Timeframe: 3 months

Population: ICER by week

Incremental Cost-effectiveness Ratio (ICER) for Significant Primary Outcomes: Depression and Competence. Costs reflect the total cost for the program per dyad per week to achieve effect in each outcome.

Outcome measures

Outcome measures
Measure	Intervention FamTechCare n=81 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Cost for FamTechCare Treatment Compared to Control Group - ICER Depression	18.51 US Dollars/Dyad/Week	—
Cost for FamTechCare Treatment Compared to Control Group - ICER Competence	36.38 US Dollars/Dyad/Week	—

Adverse Events

Intervention FamTechCare

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control and Delayed FamTechCare

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention FamTechCare n=92 participants at risk This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=97 participants at risk This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
Psychiatric disorders Attempted suicide	0.00% 0/92 • Once a week for a total of 12 weeks Adverse Event: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. Definition from January 2007 OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events.	1.0% 1/97 • Number of events 1 • Once a week for a total of 12 weeks Adverse Event: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. Definition from January 2007 OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events.

Other adverse events

Adverse event data not reported

Additional Information

Kristine Williams, RN, PhD, FNP-BC, FGSA, FAAN, E. Jean Hill Professor

University of Kansas School of Nursing

Phone: 913 588-1673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Intervention FamTechCare n=81 Participants This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Control and Delayed FamTechCare n=73 Participants This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare). FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.	Total n=154 Participants Total of all reporting groups
Age, Categorical Caregiver · <=18 years	0 Participants n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Age, Categorical Caregiver · Between 18 and 65 years	19 Participants n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	19 Participants n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	38 Participants n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Age, Categorical Caregiver · >=65 years	23 Participants n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	22 Participants n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	45 Participants n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Age, Categorical Persons with Dementia · <=18 years	0 Participants n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Age, Categorical Persons with Dementia · Between 18 and 65 years	7 Participants n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	6 Participants n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	13 Participants n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Age, Categorical Persons with Dementia · >=65 years	32 Participants n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	26 Participants n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	58 Participants n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Age, Continuous Caregiver	64.6 years STANDARD_DEVIATION 12.2 • n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	63.9 years STANDARD_DEVIATION 13.7 • n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	64.3 years STANDARD_DEVIATION 12.9 • n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Age, Continuous Persons with Dementia	75.5 years STANDARD_DEVIATION 9.7 • n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	75.9 years STANDARD_DEVIATION 9.3 • n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	75.7 years STANDARD_DEVIATION 9.5 • n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Sex: Female, Male Caregiver · Female	30 Participants n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	29 Participants n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	59 Participants n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Sex: Female, Male Caregiver · Male	12 Participants n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	12 Participants n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	24 Participants n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Sex: Female, Male Persons with Dementia · Female	15 Participants n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	14 Participants n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	29 Participants n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Sex: Female, Male Persons with Dementia · Male	24 Participants n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	18 Participants n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	42 Participants n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Ethnicity (NIH/OMB) Caregiver · Hispanic or Latino	0 Participants n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Ethnicity (NIH/OMB) Caregiver · Not Hispanic or Latino	41 Participants n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	37 Participants n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	78 Participants n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Ethnicity (NIH/OMB) Caregiver · Unknown or Not Reported	1 Participants n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	4 Participants n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	5 Participants n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Ethnicity (NIH/OMB) Persons with Dementia · Hispanic or Latino	0 Participants n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Ethnicity (NIH/OMB) Persons with Dementia · Not Hispanic or Latino	38 Participants n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	29 Participants n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	67 Participants n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Ethnicity (NIH/OMB) Persons with Dementia · Unknown or Not Reported	1 Participants n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	3 Participants n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	4 Participants n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Race (NIH/OMB) Caregiver · American Indian or Alaska Native	0 Participants n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Race (NIH/OMB) Caregiver · Asian	0 Participants n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Race (NIH/OMB) Caregiver · Native Hawaiian or Other Pacific Islander	0 Participants n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Race (NIH/OMB) Caregiver · Black or African American	4 Participants n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	1 Participants n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	5 Participants n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Race (NIH/OMB) Caregiver · White	37 Participants n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	40 Participants n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	77 Participants n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Race (NIH/OMB) Caregiver · More than one race	1 Participants n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	1 Participants n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Race (NIH/OMB) Caregiver · Unknown or Not Reported	0 Participants n=42 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=41 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=83 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Race (NIH/OMB) Persons with Dementia · American Indian or Alaska Native	0 Participants n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Race (NIH/OMB) Persons with Dementia · Asian	0 Participants n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Race (NIH/OMB) Persons with Dementia · Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Race (NIH/OMB) Persons with Dementia · Black or African American	2 Participants n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	1 Participants n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	3 Participants n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Race (NIH/OMB) Persons with Dementia · White	37 Participants n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	31 Participants n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	68 Participants n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Race (NIH/OMB) Persons with Dementia · More than one race	0 Participants n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Race (NIH/OMB) Persons with Dementia · Unknown or Not Reported	0 Participants n=39 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=32 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.	0 Participants n=71 Participants • Caregivers and Persons with Dementia reported. Combined they equal total participants.
Primary Dementia Diagnosis Alzheimer's disease	21 Participants n=39 Participants • Persons with Dementia	16 Participants n=32 Participants • Persons with Dementia	37 Participants n=71 Participants • Persons with Dementia
Primary Dementia Diagnosis Other diagnosed dementia	15 Participants n=39 Participants • Persons with Dementia	9 Participants n=32 Participants • Persons with Dementia	24 Participants n=71 Participants • Persons with Dementia
Primary Dementia Diagnosis Unknown	3 Participants n=39 Participants • Persons with Dementia	7 Participants n=32 Participants • Persons with Dementia	10 Participants n=71 Participants • Persons with Dementia
FAST Disability Category Incipient dementia	0 Participants n=39 Participants • Persons with Dementia	1 Participants n=32 Participants • Persons with Dementia	1 Participants n=71 Participants • Persons with Dementia
FAST Disability Category Mild dementia	10 Participants n=39 Participants • Persons with Dementia	10 Participants n=32 Participants • Persons with Dementia	20 Participants n=71 Participants • Persons with Dementia
FAST Disability Category Moderate dementia	7 Participants n=39 Participants • Persons with Dementia	6 Participants n=32 Participants • Persons with Dementia	13 Participants n=71 Participants • Persons with Dementia
FAST Disability Category Moderately severe dementia	21 Participants n=39 Participants • Persons with Dementia	15 Participants n=32 Participants • Persons with Dementia	36 Participants n=71 Participants • Persons with Dementia
FAST Disability Category Severe dementia	1 Participants n=39 Participants • Persons with Dementia	0 Participants n=32 Participants • Persons with Dementia	1 Participants n=71 Participants • Persons with Dementia
Number of Caregivers in Analysis 1 Caregiver	35 Participants n=39 Participants • Persons with Dementia	27 Participants n=32 Participants • Persons with Dementia	62 Participants n=71 Participants • Persons with Dementia
Number of Caregivers in Analysis 2 Caregivers	4 Participants n=39 Participants • Persons with Dementia	2 Participants n=32 Participants • Persons with Dementia	6 Participants n=71 Participants • Persons with Dementia
Number of Caregivers in Analysis 3 Caregivers	0 Participants n=39 Participants • Persons with Dementia	2 Participants n=32 Participants • Persons with Dementia	2 Participants n=71 Participants • Persons with Dementia
Number of Caregivers in Analysis 4 Caregivers	0 Participants n=39 Participants • Persons with Dementia	1 Participants n=32 Participants • Persons with Dementia	1 Participants n=71 Participants • Persons with Dementia
Caregiver's Relationship to Person with Dementia Spouse	29 Participants n=42 Participants • Caregivers	26 Participants n=41 Participants • Caregivers	55 Participants n=83 Participants • Caregivers
Caregiver's Relationship to Person with Dementia Child/Spouse of child	12 Participants n=42 Participants • Caregivers	15 Participants n=41 Participants • Caregivers	27 Participants n=83 Participants • Caregivers
Caregiver's Relationship to Person with Dementia Other	1 Participants n=42 Participants • Caregivers	0 Participants n=41 Participants • Caregivers	1 Participants n=83 Participants • Caregivers