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Completed

NCT Number: NCT05501119

SUPPORT-D Intervention for Persons With Alzheimer's Disease and Their Caregivers

The purpose of this research is pilot test a nurse led intervention previously used in patients with pulmonary fibrosis and their caregivers in a new population (persons living with Mild Cognitive Impairment or Alzheimer's disease and their caregivers. The researchers hypothesize improving advanced care planning in this population will result in enhanced quality of life over illness trajectory and improve safety for community dwelling PWD/CG dyads. Findings from this study will inform additional necessary adaptations required prior to conducting larger scale powered randomized control trial.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The participants in this study include persons with Alzheimer's disease (PWD) and their caregivers (CG.

  • Persons with Alzheimer's Disease (investigators anticipate cognitive impairment within this group)
  • 18 years old or older
  • Diagnosis of Alzheimer's Disease or suspected Alzheimer's disease (FAST score < 4)
  • Able to read and speak English (intervention in English)

Caregivers (CG)

  • > 18 years old
  • Non-paid (eliminates professional caregivers)
  • Provides care to someone living with Alzheimer's Disease or suspected Alzheimer's disease (self-report)
  • Able to read and speak English (written materials in English)
  • No diagnosis of cognitive impairment

Exclusion criteria

  • Inability or unwillingness to provide informed consent

Treatment and study plan

A Program of SUPPORT-D (dementia)

Behavioral

The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).

Primary outcomes

  1. Change in Alzheimer's Disease Knowledge Scale (ADKS) Score

    Time frame: baseline, at study completion, an average of 8 weeks

    30 items (T/F) summed total of correct items higher score indicates higher knowledge (scores range from 0-30)

  2. Acceptability of Intervention Measure (AIM) Score

    Time frame: at study completion, an average of 8 weeks

    4 items (5 point Likert scale) average score across items higher score indicates more acceptability of intervention (raw score ranges from 4-20)

  3. Feasibility Score

    Time frame: at study completion, an average of 8 weeks

    4 items (5 point Likert scale) average score across items higher score indicates greater feasibility of intervention (raw scores range from 4-20)

  4. Change Zarit Caregiver Burden Score

    Time frame: baseline, at study completion, an average of 8 weeks

    12 items (5 point Likert scale (0-4)) summed score with higher scores indicating greater caregiver distress (raw scores range from 0-48)

  5. Change in Perceived Stress Scale Score

    Time frame: baseline and at study completion, an average of 8 weeks

    10 items (4 point Likert scale ranging from 0-4) summed score across items with higher scores indicate greater levels of stress (scores range from 0-40)

  6. Change in Quality of Life-Alzheimer's Disease (QoL-AD) Score

    Time frame: baseline and at study completion, an average of 8 weeks

    13 items (4 point Likert scale ranging from 1-4) summed score across items with higher scores indicating better quality of life (scores range from 13-52)

  7. Change in Self-efficacy for Caregiving Score

    Time frame: baseline and at study completion, an average of 8 weeks

    8 items rated from 1-10 mean score across items with higher scores indicating higher self-efficacy (raw scores range from 8-80)

  8. Change in Safety Assessment Scale Score

    Time frame: baseline and at study completion, an average of 8 weeks

    16 items with response options ranging from 0 to 4. The minimum score is 0, indicating no safety concerns, while the maximum score is 64, indicating significant safety risks.

  9. Appropriateness of Intervention Score

    Time frame: at study completion, an average of 8 weeks

    4 items (5 point Likert scale) average score across items higher score indicates greater appropriateness of intervention (scores range from 4-20)

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Palliative Care Telehealth Delivered Program of SUPPORT-D Intervention for Persons With Alzheimer's Disease and Caregivers Phase 2

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2022
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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