Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Supportive Care for Cognitively Impaired Patients and Families

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03881579
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
VJ Periyakoil, Stanford University

Brief Summary:
Currently almost 5 million Americans suffer from the distressing symptoms related to dementia and this number that will triple by 2050. The overall goals of the proposed project are to evaluate, in community dwelling Alzheimer's Disease Research Center participants the benefits of a 12-month nurse-led early palliative intervention on symptoms, quality of life, health care resource use. The relevance of this research to public health is that there is an urgent need to improve the palliative care of persons with dementia living in the community. This study will contribute substantially to that effort.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: nurse-led supportive care assessment Not Applicable

Detailed Description:
200 ADRC participants will be recruited and randomizes 100 each to usual care (UC) or {usual care plus an early palliative care intervention} (EPC) to be delivered by a nurse over a twelve-month period. The EPC will include one nurse-led palliative consult in a two-hour house call and followed by 11 monthly 30-minute phone assessment plus usual care. The study aims are to determine whether EPC will lead to lower symptom burden, higher quality of life, lesser resource use (e.g. hospital admissions and days, emergency visits) & greater patient activation. Mixed-methods framework will be utilized to analyze the audiotapes of the encounters between the research nurse and the patient during the twelve intervention sessions and to assess whether the information that is provided to participants differs by patient ethnicity and cognitive levels.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

patients will be randomized to one of two groups:

1. (usual care) or (2). enhanced usual care i.e. usual care plus supportive care provided by a trained and supervised nurse

Masking: Single (Outcomes Assessor)
Masking Description: Outcomes will be assessed by blinded research associates
Primary Purpose: Supportive Care
Official Title: Supportive Care for Cognitively Impaired Patients and Families
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Usual care
one random half of patients will receive usual care
Behavioral: nurse-led supportive care assessment
Trained project nurses will conduct systematic assessment and provide coaching to patients in the experimental arm

Experimental: intervention arm
one random half of patients will receive enhanced usual care (usual care plus nurse-led supportive care intervention)
Behavioral: nurse-led supportive care assessment
Trained project nurses will conduct systematic assessment and provide coaching to patients in the experimental arm




Primary Outcome Measures :
  1. Change in Edmonton Symptoms Assessment Scale (ESAS) scores [ Time Frame: Day 0, one year, two years ]
    This ESAS is designed to assist in the assessment of nine symptoms common in patients: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing and shortness of breath, (there is also a line labelled "Other Problem"). The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity. The patient and family should be taught how to complete the scales. It is the patient's opinion of the severity of the symptoms that is the "gold standard" for symptom assessment. We will assess change in ESAS scores between three points in time to determine changes (if any) over time: on study entry, one year later and two year later.

  2. Change in Quality-of-life Alzheimer's Disease scores over time [ Time Frame: Day 0, one year, two years ]

    QOL AD measures quality of life. It has 13 questions and Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.

    The total score is the sum of all 13 items.: We will assess change in QOL scores between three points in time : on study entry, one year later and two year later.


  3. Change in Zarit Caregiver Burden scores over time: [ Time Frame: Day 0, one year, two years ]
    The Zarit Burden Interview contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always) . The factor structure is a two-factor model, addressing personal strain and role strain. We will assess change in Zarit scores between three points in time : on study entry, one year later and two year later.


Secondary Outcome Measures :
  1. Change in Patient Activation Measure over time [ Time Frame: one year, two years ]

    3-item survey that assesses a person's underlying knowledge, skills and confidence integral to managing his or her own health and healthcare.

    PAM segments individuals into one of four activation levels along an empirically derived 100-point scale. Each level provides insight into an extensive array of health-related characteristics, including attitudes, motivators, and behaviors. Individuals in the lowest activation level do not yet understand the importance of their role in managing their own health, and have significant knowledge gaps and limited self-management skills. Individuals in the highest activation level are proactive with their health, have developed strong self-management skills, and are resilient in times of stress or change. PAM measures patient activation and agency: We will assess changes in activation scores in ESAS scores between three points in time : on study entry, one year later and two year later.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients enrolled in our alzheimers disease research center.
  • All caregivers enrolled in our alzheimers disease research center.

Exclusion Criteria:

  1. not a community dweller at the time of entry into the study;
  2. have severe dementia and are incapable of responding to the outcome measures at baseline. 3. Participants who live alone and don't have a proxy will be excluded only if they are deemed as lacking capacity to provide informed consent at the time of entry into the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881579


Contacts
Layout table for location contacts
Contact: VJ Periyakoil, MD 6507234000 periyakoil@stanford.edu

Locations
Layout table for location information
United States, California
VJ Periyakoil
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
Layout table for investigator information
Principal Investigator: VJ Periyakoil, MD Stanford University

Layout table for additonal information
Responsible Party: VJ Periyakoil, Director. Palliative Care Education & Training, Stanford University
ClinicalTrials.gov Identifier: NCT03881579     History of Changes
Other Study ID Numbers: 48000
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: this will depend on if patients consent or not for release of data

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No