Care to Plan: a Tailored Resource for Family Members of Persons With Dementia

NCT03901456 | Completed Results

• 2 other identifiers: STUDY000059711R21AG060419-01A1
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will refine and conduct a preliminary efficacy evaluation of Care to Plan. Care to Plan is an online care planning tool that provides a succinct and clear overview of various types of dementia caregiver interventions, administers a brief validated assessment of risk, and generates individualized recommendations for dementia caregivers as well as resources that link users to a selected recommendation. There remains a lack of individualized information that can directly meet the diverse needs of caregivers or their relatives with Alzheimer's disease or a related dementia (ADRD). This project will advance scientific knowledge, technical capability, and clinical practice as they pertain to ADRD management and caregiver support.

Conditions

Dementia; Alzheimer Disease; Memory Loss

Keywords

Caregiving

Outcome Measures

Primary Outcomes (1)

• Caregiver Self-efficacy

  Eight-item survey developed by Fortinsky and colleagues. Responses for each item range from 1 (Very unconfident) to 5 (Very confident), with higher scores indicating greater self-efficacy. The 8-item responses are averaged. Mean of participant scores is reported.

  Phase II Baseline, 3-months, 6-months

Secondary Outcomes (5)

• Care to Plan Service Use

  Phase II Baseline, 3-months, 6-months

• Phase II - Caregiver Distress: Role Overload

  Phase II Baseline, 3-months, 6-months

• Primary Subjective Stressors: Loss of Intimate Exchange

  Phase II Baseline, 3-month, 6-month

• Caregiver Distress: Role Captivity

  Phase II Baseline, 3-months, 6-months

• Center for Epidemiological Studies Depression (CES-D)

  Phase II Baseline, 3-months, 6-months

Other Outcomes (1)

• Acceptability and Feasibility

  Phase I at 1-month follow up

Study Arms (3)

Phase II [Randomized]: Treatment

EXPERIMENTAL

Participants randomized to this treatment arm will receive the Care to Plan (CtP) intervention as a part of Phase II.

Behavioral: Care to Plan

Phase II [Randomized]: Control

ACTIVE COMPARATOR

Participants randomized to a usual care control group as a part of Phase II. Note: If eligible, participants in this control group will be asked if they are interested in enrolling in a similar, additional feature of the study to test the Care to Plan tool following the initial 6-month study.

Behavioral: Usual Care

Phase I [Non-randomized]: Treatment

EXPERIMENTAL

Participants enrolled in Phase I of the project to receive the intervention \[non-randomized; no comparison group\].

Behavioral: Care to Plan

Interventions

Care to Plan BEHAVIORAL

Care to Plan (CtP) is an online care planning tool that provides a succinct and clear overview of various types of ADRD caregiver interventions, administers a brief validated assessment of risk, and generates individualized service recommendations for Alzheimer's disease and related dementia (ADRD) caregivers as well as resources that link users to a selected recommendation. Caregivers will complete the tool with the guidance of a CtP interventionist (Senior Care Navigator/Riverside Health System staff). The interventionist will discuss CtP recommendations with caregivers and help caregivers enroll in a recommended support service if so desired.

Phase I [Non-randomized]: Treatment; Phase II [Randomized]: Treatment

Usual Care BEHAVIORAL

Receive care as usual. Note: If eligible, participants in this control group will be asked if they are interested in enrolling in a similar, additional feature of the study to test the Care to Plan tool following the initial 6-month study.

Phase II [Randomized]: Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

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

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (3)

• Pearlin LI, Mullan JT, Semple SJ, Skaff MM. Caregiving and the stress process: an overview of concepts and their measures. Gerontologist. 1990 Oct;30(5):583-94. doi: 10.1093/geront/30.5.583.

  PMID: 2276631 BACKGROUND

• Fortinsky RH, Kercher K, Burant CJ. Measurement and correlates of family caregiver self-efficacy for managing dementia. Aging Ment Health. 2002 May;6(2):153-60. doi: 10.1080/13607860220126763.

  PMID: 12028884 BACKGROUND

• Radloff, L. S. (1977). The CES-D Scale: A Self-Report Depression Scale for Research in the General Population. Applied Psychological Measurement, 1(3), 385-401. https://doi.org/10.1177/014662167700100306

  BACKGROUND

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Memory Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Joseph Gaugler, PhD
• Organization: University of Minnesota

gaug0015@umn.edu

612-626-2485

Study Officials

• Joseph E Gaugler, PhD

  University of Minnestoa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase I of the study will include enrollment of 20 participants to test and refine the online tool \[non-randomized\]; in Phase II, we aim to enroll 100 participants to generate preliminary evaluation data \[randomized\].

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 3, 2019
• Study Start: September 1, 2019
• Primary Completion: May 24, 2022
• Study Completion: May 24, 2022
• Last Updated: June 2, 2023
• Results First Posted: June 2, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)