Virtual Coaching to Maximize Dementia Caregivers' Respite Time Use

NCT03689179 | Completed Results DMC

• 2 other identifiers: 1R01AG061946-01 (Utz)R01AG061946
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

The "Time for Living \& Caring" (TLC) intervention is an online, self-administered intervention, with the purpose of providing informal family caregivers with resources, support, and education to maximize the benefit of their respite time-use (respite is defined as planned time away from caregiving; it can be provided by a formal service provider or informal arrangements within families/networks). The study will use a full-powered pilot sample (anticipated n=150; actual n=166) and a randomized waitlist control design to examine feasibility and initial efficacy of the TLC intervention.

Conditions

Anxiety; Burden, Dependency; Caregiver

Outcome Measures

Primary Outcomes (2)

• Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form

  Anxiety was measured with the PROMIS Anxiety short-form questionnaire for adults, a self-report, 8-item additive scale that standardizes the distribution of anxiety-related symptoms (T-score) on a population-distribution with a mean of 50 and standard deviation of 10: "During the past 7 days, I felt nervous, anxious, fearful, uneasy, tense, worried, unable to focus on anything other than my anxiety, felt like I needed help with my anxiety" each assessed with a five-category response (never, rarely, sometimes, often, always). Higher scores indicate a higher level of anxiety.

  Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B

• Caregiver Burden Score, as Measured by "Caregiver Burden Inventory"

  Self-report multi-item index (24 items; range 0-96). Lower scores indicate lower levels of caregiver burden. Higher scores indicate higher levels of perceived burden associated with caregiving tasks.

  Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B

Secondary Outcomes (2)

• Respite Time-Use (in Hours Per Week)

  Pre-Intervention (baseline, week 1) and Post-Intervention (week-16) for both Group A and Group B

• Respite Satisfaction: Count (%) of Participants Who Agreed or Strongly Agreed With the Statement "I am Happy With What I Choose to do During Respite"

  Pre-Intervention (baseline, week 1) and Post-Intervention (week 16) for both Group A and Group B

Other Outcomes (1)

• Depressive Symptoms, as Measured by the "PROMIS Depression Scale (Vol 1 Short Form)"

  Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B

Study Arms (2)

Treatment with Follow-up (Group A)

EXPERIMENTAL

Group A received access to the full "Time for Living \& Caring" (TLC) intervention for 8 weeks (calendar + coaching + resources), followed by an 8-week maintenance period where they could continue to use the TLC intervention. The TLC intervention turned off after 16 weeks of exposure for all participants.

Behavioral: Time for Living and Caring (TLC)

Wait-List Control w/Treatment (Group B)

EXPERIMENTAL

Group B received 8 weeks of waitlist control (minimal treatment - calendar only) , followed by access to the full "Time for Living \& Caring" (TLC) intervention for an additional 8 weeks (calendar + coaching + resources). The TLC intervention turned off after 16 weeks of exposure for all participants.

Behavioral: Time for Living and Caring (TLC)

Interventions

Time for Living and Caring (TLC) BEHAVIORAL

"Time for Living \& Caring" (TLC) is an online, self-administered intervention. It includes three types of modules: 1) "virtual coaching" module (defined as a series of prompts, reminders, and suggestions that guide caregivers through assessment, goal setting, and goal review activities) to monitor respite time-use and time-use goals, 2) an interactive calendar that can be used to schedule and track respite time, 3) resource pages (including links, printable forms, video guides) that provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?.

Treatment with Follow-up (Group A); Wait-List Control w/Treatment (Group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• caregivers to persons with Alzheimer's Disease or Related Dementia (AD/ADRD) (self-identified)
• use formal or informal respite for at least 4 hours per week.
• primary caregiver (self-identified)
• co-residing with the care recipient
• years or older AND
• able to read and write in English.

You may not qualify if:

• caregivers to persons with disability or chronic condition, and not Alzheimer's Disease and Related Dementia (AD/ADRD)
• caregivers who do not use respite for at least 4 hours per week
• noncoresidential caregivers
• younger than 18 years
• not able to read and write in English

Sponsors & Collaborators

• University of Utah: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Iacob E, Caserta M, Donaldson G, Sparks C, Terrill A, Thompson A, Wong B, Utz RL. Evaluating the Efficacy of Time for Living and Caring: An Online Intervention to Support Dementia Caregivers' Use of Respite. Innov Aging. 2024 Apr 26;8(5):igae043. doi: 10.1093/geroni/igae043. eCollection 2024.

  PMID: 38803611 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Time

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Physical Phenomena

Limitations and Caveats

NA. The trial was recruited and analyzed as planned.

Results Point of Contact

• Title: Rebecca Utz
• Organization: University of Utah

rebecca.utz@utah.edu

801 699 5685

Study Officials

• rebecca utz, PhD

  University of Utah

  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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study uses a full-powered pilot sample (n=150) and a randomized waitlist control design to examine feasibility and initial efficacy of the TLC intervention. After an initial orientation/control period (4 weeks), group A will receive access to the TLC intervention for 8 weeks, followed by an optional 8-week control period where they can continue to use the TLC intervention if they choose. After the initial 4-week orientation period, Group B will receive 8 weeks of waitlist (no treatment) control, followed by access to the TLC intervention for 8 weeks. Primary outcomes (defined as anxiety, caregiver burden) will be assessed by electronically delivered surveys every 4 weeks; respite time-use and time-use satisfaction will be assessed using ecological momentary analysis for each respite period taken during the 20-week study period; feasibility will be assessed using fixed-choice and open-ended survey questions collected post-intervention.

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 28, 2018
• Study Start: October 20, 2020
• Primary Completion: August 5, 2022
• Study Completion: May 1, 2024
• Last Updated: October 15, 2024
• Results First Posted: March 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Within one year of the completion of the funded project period.
• Access Criteria: Investigators working under an institution with a Federal Wide Assurance (FWA) can email the PI directly, asking for permission

Locations

US (1)