Supporting Family Caregivers With Technology for Dementia Home Care

NCT02483520 | Completed Results DMC

• 2 other identifiers: STUDY00000053R01NR014737
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical trial will test the FamTechCare intervention that uses multidisciplinary professional guidance based on in-home video monitoring to support family caregivers in managing challenging behaviors of persons with dementia (PWD). Families provide the majority of care for PWD at home. However the stress of caregiving is so significant that it increases caregiver morbidity and mortality. Stress is magnified by disruptive behaviors in PWD that frequently lead to nursing home placement. In-home video monitoring allows experts to assess behaviors of PWD and to identify antecedents, recommend specific interventions. FamTechCare uses new technology to link family caregivers to experts for guidance in managing disruptive behaviors, supporting continued care at home while reducing the negative effects of caregiving. Caregiver-PWD dyads (N=88) will be randomly assigned to intervention or control groups. Both groups will record behaviors during daily care for 3 months using a home monitoring unit. Notably, this new technology captures 3-5 minutes prior to the behavior, thus recording behavior triggers and precursors. Caregivers record care situations they select and upload videos to a secure site. The expert team will review intervention group videos weekly and will provide individualized feedback for improving care to caregivers in the home. The control group caregivers will receive a weekly phone call and advice from a nurse, but their recorded videos will be held for review and individualized feedback provided after 3 months. Study aims are to use observation to assist caregivers in behavior management. Effects on disruptive behaviors and caregiver burden and other negative outcomes will be compared. Investigators will evaluate ease of use and satisfaction, cost-efficiency, and factors influencing likelihood of translation into practice. This is the first study to test new technology for direct observation and immediate feedback to empower families to manage PWD behaviors at home while reducing caregiver stress and morbidity. Technology links caregivers to individualized expert guidance, acknowledging the importance and burden of their role. This study addresses NIH missions and the 2012 National Plan to Address Alzheimer's disease goals, integrating strategies to promote adoption and use of aging services technologies in interventions that will reduce negative caregiver outcomes, a growing public health problem.

Conditions

Dementia

Keywords

Family caregiver

Outcome Measures

Primary Outcomes (15)

• Change in Behaviorally Coded Challenging Behaviors (Agitated, Disruptive, Resistive)

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

  3 months

• Change in Caregiver Stress - Reaction to Memory Symptoms (Bother)

  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.

  Baseline, 1 month, 3 months

• Change in Caregiver Stress - Reaction to Depressive Symptoms (Bother)

  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.

  Baseline, 1 month, 3 months

• Change in Caregiver Stress - Desire to Instituionalize

  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.

  Baseline, 1 month, 3 months

• Change in Caregiver Stress - Biological Sensor Data

  Biological stress reactions measured by sensor

  Baseline, 1 month, 3 months

• Change in Caregiver Burden

  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.

  Baseline, 1 month, 3 months

• Change in Caregiver Health and Wellbeing - Depression

  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.

  Baseline, 1 month, 3 months

• Change in Caregiver Health and Wellbeing - Competence

  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).

  Baseline, 1 month, 3 months

• Change in Caregiver Health and Wellbeing - Sleep Disturbance

  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.

  Baseline, 1 month, 3 months

• Change in Caregiver Health and Wellbeing - Medication Use

  Caregivers taking PRN anxiolytics, hypnotics, or antipsychotic medication.

  Baseline, 1 month, 3 months

• Change in Caregiver Health and Wellbeing - Confidence in Managing BPSD

  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.

  Baseline, 3 months

• Change in Caregiver Health and Wellbeing - Confidence in Managing Disease Expectations

  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.

  Baseline, 3 months

• Change in Caregiver Health and Wellbeing - Confidence in Managing ADLs (Activities of Daily Living)

  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.

  Baseline, 3 months

• Change in Caregiver Reported Challenging Behaviors - Reaction to Disruptive Symptoms (Bother)

  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.

  Baseline, 1 month, 3 months

• Change in Caregiver Reported Challenging Behaviors - Frequency of Disruptive Behaviors

  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.

  Baseline, 1 month, 3 months

Secondary Outcomes (2)

• Cost for FamTechCare Treatment Compared to Control Group

  3 months

• Cost for FamTechCare Treatment Compared to Control Group - ICER

  3 months

Study Arms (2)

Intervention FamTechCare

EXPERIMENTAL

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).

Behavioral: FamTechCare

Control and Delayed FamTechCare

PLACEBO COMPARATOR

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).

Behavioral: FamTechCare

Interventions

FamTechCare BEHAVIORAL

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; Intervention FamTechCare

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Person caring for someone with a diagnosis of Alzheimer's disease or other dementia at home.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

University of Iowa College of Nursing

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

• Williams K, Arthur A, Niedens M, Moushey L, Hutfles L. In-home monitoring support for dementia caregivers: a feasibility study. Clin Nurs Res. 2013 May;22(2):139-50. doi: 10.1177/1054773812460545. Epub 2012 Sep 20.

  PMID: 22997349 RESULT

• Kim S, Shaw C, Williams KN, Hein M. Typology of Technology-Supported Dementia Care Interventions From an In-Home Telehealth Trial. West J Nurs Res. 2019 Dec;41(12):1724-1746. doi: 10.1177/0193945919825861. Epub 2019 Jan 28.

  PMID: 30688175 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Kristine Williams, RN, PhD, FNP-BC, FGSA, FAAN, E. Jean Hill Professor
• Organization: University of Kansas School of Nursing

Kwilliams1@kumc.edu

913 588-1673

Study Officials

• Kristine N Williams, RN, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 29, 2015
• Study Start: March 1, 2014
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: November 13, 2020
• Results First Posted: November 13, 2020

Record last verified: 2020-10

Locations

US (2)