Supportive Care for Cognitively Impaired Patients and Families

Dementia Clinical Trial

Official title:

Supportive Care for Cognitively Impaired Patients and Families

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03881579
• Other study ID #: 48000
• Secondary ID: R01AG062239-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 18, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

200 ADRC participants will be recruited and randomized 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 for a two-hour virtual session followed by 11 monthly 30-minute phone/video sessions plus usual care. The study aims are to determine whether EPC will lead to (a) eliciting and alleviating the supportive care needs of patients, (b) help them complete and sign (with witnesses) their Advance Directives and the POLST (signed by the patient/proxy and their doctor) upload these into the electronic health records. Exploratory outcomes will include health resource use (e.g. hospital admissions and days, emergency visits) for the participants and caregiver burden for their caregivers. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• All patients enrolled in the Stanford Alzheimers Disease Research Center (SADRC).

• All caregivers enrolled in the Stanford Alzheimers Disease Research Center (SADRC).

Exclusion Criteria:

1. Institutionalized (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 the capacity to provide informed consent at the time of entry into the study.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

Behavioral:
• nurse-led supportive care assessment
Trained project nurses will conduct systematic assessment and provide coaching to patients in the experimental arm

Locations

Country	Name	City	State
United States	VJ Periyakoil	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify the number of participants who express supportive care needs in both arms.	Only the participants randomized to the intervention arm will receive the nurse-led supportive care intervention (one session per month over a twelve-month period).; We hypothesize that compared to the control arm, many more patients in the intervention arm will express supportive needs and have them fulfilled by the study nurses.	Day 0, 4 months, one year
Primary	Completion and documentation of advance directives (AD) and the Physicians Orders for Life Sustaining Treatment (POLST) in the electronic health records.	In both arms the investigators will track the completion, signage and documentation of advance directives and the POLST. AD has to be signed by the patient or proxy and witnessed by two qualifying witnesses. The POLST has to be signed by the patient/proxy and the patient's doctor. Both forms have to be uploaded into the electronic health records.	Day 0, 4 months, one year, 18 months
Primary	Change in Zarit Caregiver Burden scores over time:	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. The investigators will assess change in Zarit scores between three points in time : on study entry, one year later and two year later.	Day 0, 4 months, one year, 18 months
Secondary	Differences in Edmonton Symptoms Assessment Scale (ESAS) scores	The 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 investigators will assess change in ESAS score of all participants at baseline, months 4, 12 and 18. The investigators hypothesize that patients with cognitive impairment will have higher scores than those with normal cognition. The investigators will also determine changes in the ESAS score (if any) over time.	Day 0, 4 months, one year, 18 months
Secondary	Change in Patient Activation Measure over time	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: The investigators will assess changes in activation scores in ESAS scores between three points in time : on study entry, one year later and two year later.	one year, two years