Telehealth-enabled Integrated Palliative Care for People With Dementia

NCT05524181 | Completed

• 2 other identifiers: 080-27000-U33701#22G.239
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In prior work, this team developed a telehealth primary care model (TIPC), designed in close partnership with patients and clinicians to address a widespread increase in telehealth use during the COVID-19 pandemic. This research team will test the TIPC intervention to assess support for patients among a population of persons with dementia (PwD). Participants will be enrolled in the study for a 12 month period. This study's aims are 1) to explore the impact of the TIPC intervention on patient-important outcomes, engagement with community-based support provided through insurers, advanced care planning (primarily identification of health-care proxy), and patterns of hospice and healthcare utilization in the target population and 2) to evaluate patient, caregiver, and clinical team perspectives of feasibility and acceptability of a TIPC model, and apply findings from this work to the development of a larger randomized control trial designed to assess long-term efficacy of TIPC intervention.

Conditions

Dementia of Alzheimer Type; Alzheimer Disease; Frontotemporal Degeneration; Lewy Body Dementia; Vascular Cognitive Impairment; Vascular Dementia; Mixed Dementia

Outcome Measures

Primary Outcomes (19)

• Change in Goal Attainment

  Participants identify their own primary goals related to their care using the Goal Attainment Scaling (GAS) system, and report the degree to which each goal was met. Patients will set 2 concrete care goals and report if they feel like they met these goals much less than expected, less than expected, as expected, more than expected, or much more than expected.

  3 months

• Change in Goal Attainment

  Participants identify their own primary goals related to their care using the Goal Attainment Scaling (GAS) system, and report the degree to which each goal was met. Patients will set 2 concrete care goals and report if they feel like they met these goals much less than expected, less than expected, as expected, more than expected, or much more than expected.

  6 months

• Change in Goal Attainment

  Participants identify their own primary goals related to their care using the Goal Attainment Scaling (GAS) system, and report the degree to which each goal was met. Patients will set 2 concrete care goals and report if they feel like they met these goals much less than expected, less than expected, as expected, more than expected, or much more than expected.

  9 months

• Change in Goal Attainment

  Participants identify their own primary goals related to their care using the Goal Attainment Scaling (GAS) system, and report the degree to which each goal was met. Patients will set 2 concrete care goals and report if they feel like they met these goals much less than expected, less than expected, as expected, more than expected, or much more than expected.

  12 months

• Change in Disease-Related Quality of Life

  Participants report their overall quality of life by utilizing the Quality of Life in Alzheimer's Disease Scale (QoL-AD). These metrics include but are not limited to: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. A summary index score is derived by applying an appropriate value set to the responses for each question (poor=1, fair=2, good=3, excellent=4). Patients can score up to 52 points with a higher score being associated with a higher quality of life.

  Baseline

• Change in Disease-Related Quality of Life

  Participants report their overall quality of life by utilizing the Quality of Life in Alzheimer's Disease Scale (QoL-AD). These metrics include but are not limited to: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. A summary index score is derived by applying an appropriate value set to the responses for each question (poor=1, fair=2, good=3, excellent=4). Patients can score up to 52 points with a higher score being associated with a higher quality of life.

  3 months

• Change in Disease-Related Quality of Life

  Participants report their overall quality of life by utilizing the Quality of Life in Alzheimer's Disease Scale (QoL-AD). These metrics include but are not limited to: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. A summary index score is derived by applying an appropriate value set to the responses for each question (poor=1, fair=2, good=3, excellent=4). Patients can score up to 52 points with a higher score being associated with a higher quality of life.

  6 months

• Change in Disease-Related Quality of Life

  Participants report their overall quality of life by utilizing the Quality of Life in Alzheimer's Disease Scale (QoL-AD). These metrics include but are not limited to: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. A summary index score is derived by applying an appropriate value set to the responses for each question (poor=1, fair=2, good=3, excellent=4). Patients can score up to 52 points with a higher score being associated with a higher quality of life.

  9 months

• Change in Disease-Related Quality of Life

  Participants report their overall quality of life by utilizing the Quality of Life in Alzheimer's Disease Scale (QoL-AD). These metrics include but are not limited to: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. A summary index score is derived by applying an appropriate value set to the responses for each question (poor=1, fair=2, good=3, excellent=4). Participants can score up to 52 points with a higher score being positively associated with a higher quality of life.

  12 months

• Change in Decision-Making

  Participants assess the extent to which they are involved in everyday decision making (e.g., when to get up, what foods to buy) the Decision-Making Involvement Scale (DMI). A summary index score is derived by applying an appropriate value set to the responses for each question (not at all involved=0, a little involved=1, fairly involved=2, very involved=3). Participants can score up to 45 points with a higher score being positively associated with a higher level of decision involvement.

  Baseline

• Change in Decision-Making

  Participants assess the extent to which they are involved in everyday decision making (e.g., when to get up, what foods to buy) the Decision-Making Involvement Scale (DMI). A summary index score is derived by applying an appropriate value set to the responses for each question (not at all involved=0, a little involved=1, fairly involved=2, very involved=3). Participants can score up to 45 points with a higher score being positively associated with a higher level of decision involvement.

  3 months

• Change in Decision-Making

  Participants assess the extent to which they are involved in everyday decision making (e.g., when to get up, what foods to buy) the Decision-Making Involvement Scale (DMI). A summary index score is derived by applying an appropriate value set to the responses for each question (not at all involved=0, a little involved=1, fairly involved=2, very involved=3). Participants can score up to 45 points with a higher score being positively associated with a higher level of decision involvement.

  6 months

• Change in Decision-Making

  Participants assess the extent to which they are involved in everyday decision making (e.g., when to get up, what foods to buy) the Decision-Making Involvement Scale (DMI). A summary index score is derived by applying an appropriate value set to the responses for each question (not at all involved=0, a little involved=1, fairly involved=2, very involved=3). Participants can score up to 45 points with a higher score being positively associated with a higher level of decision involvement.

  9 months

• Change in Decision-Making

  Participants assess the extent to which they are involved in everyday decision making (e.g., when to get up, what foods to buy) the Decision-Making Involvement Scale (DMI). A summary index score is derived by applying an appropriate value set to the responses for each question (not at all involved=0, a little involved=1, fairly involved=2, very involved=3). Participants can score up to 45 points with a higher score being positively associated with a higher level of decision involvement.

  12 months

• Change in Caregiver Support/Burden

  Caregivers of participants explore the personal and role strain that they experience via the Zarit Burden Inventory (ZBI22). A summary index score is derived by applying an appropriate value set to the responses for each question (never=1, rarely=2, sometimes=3, quite frequently=4, nearly always=5). Participants can score up to 88 points with a higher score being negatively associated with a higher level of burden experienced by the caregiver.

  Baseline

• Change in Caregiver Support/Burden

  Caregivers of participants explore the personal and role strain that they experience via the Zarit Burden Inventory (ZBI22). A summary index score is derived by applying an appropriate value set to the responses for each question (never=1, rarely=2, sometimes=3, quite frequently=4, nearly always=5). Participants can score up to 88 points with a higher score being negatively associated with a higher level of burden experienced by the caregiver.

  3 months

• Change in Caregiver Support/Burden

  Caregivers of participants explore the personal and role strain that they experience via the Zarit Burden Inventory (ZBI22). A summary index score is derived by applying an appropriate value set to the responses for each question (never=1, rarely=2, sometimes=3, quite frequently=4, nearly always=5). Participants can score up to 88 points with a higher score being negatively associated with a higher level of burden experienced by the caregiver.

  6 months

• Change in Caregiver Support/Burden

  Caregivers of participants explore the personal and role strain that they experience via the Zarit Burden Inventory (ZBI22). A summary index score is derived by applying an appropriate value set to the responses for each question (never=1, rarely=2, sometimes=3, quite frequently=4, nearly always=5). Participants can score up to 88 points with a higher score being negatively associated with a higher level of burden experienced by the caregiver.

  9 months

• Change in Caregiver Support/Burden

  Caregivers of participants explore the personal and role strain that they experience via the Zarit Burden Inventory (ZBI22). A summary index score is derived by applying an appropriate value set to the responses for each question (never=1, rarely=2, sometimes=3, quite frequently=4, nearly always=5). Participants can score up to 88 points with a higher score being negatively associated with a higher level of burden experienced by the caregiver.

  12 months

Secondary Outcomes (1)

• Feasibility, Acceptability, and Satisfaction regarding TIPC Intervention

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Individuals in the intervention group will undergo a series of two telehealth video visits and a series of survey assessments at baseline, 3, 6, 9, and 12 months.

Other: Telehealth Integrated Primary Care (TIPC)

Control

NO INTERVENTION

Individuals in the control group will continue with their usual standard of care and undergo a series of survey assessments at baseline, 3, 6, 9 and 12 months.

Interventions

Telehealth Integrated Primary Care (TIPC) OTHER

The TIPC model of intervention incorporates video visits across research clinicians and patients' existing care clinicians for more synergized and accessible care provision for a given clinical indication. The first TIPC visit will center around the patient setting care goals for themselves and their caregiver with the help of a palliative care physician. The second TIPC visit will focus on assessing goal attainment and also close the care loop between their existing care team, a research-appointed palliative care team, and their involvement in the study.

Also known as: TIPC

Intervention

Eligibility Criteria

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

You may qualify if:

• Over 18
• Individuals diagnosed with Alzheimer's Disease, Alzheimer's Disease Related Dementias, (including frontotemporal degeneration, Lewy body dementia, vascular contributions to cognitive impairment and dementia, or mixed etiology dementias), or patients billed for cognitive impairment in the last three years that have a Jefferson PCP
• Individuals with access to a smart phone, computer, or some other telehealth-capable technology
• English-speaking individuals

You may not qualify if:

• Traumatic Brain Injuries
• Incarceration
• Homelessness
• Pregnancy

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Independence Blue Cross: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Lewy Body Disease; Dementia, Vascular; Mixed Dementias

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

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: Principal Investigator

Model Details: Participants will be randomized to intervention or control group

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 1, 2022
• Study Start: June 29, 2022
• Primary Completion: August 1, 2024
• Study Completion: November 14, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

US (1)