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Primary Progressive AphasiaNCT04412083

PPA Tele-Savvy: A Pilot Study of an Online Intervention for Caregivers of Persons Living With PPA

A study testing PPA Tele-Savvy Pilot Intervention in people with Primary Progressive Aphasia and Caregiver Burnout, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary goal of this pilot project is to adapt an evidence-informed on-line psychoeducation program (Tele-Savvy) to address the unique challenges facing informal caregivers of those living with PPA and geared toward achieving caregiver mastery in this population. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PPA Tele-Savvy Pilot Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited States
Study dates
30 Jul 2020to 19 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aim 1:
  • Informal (family or friends) caregivers of persons living with or deceased from PPA.
  • Age 18 or over Providing or have provided at least 2 hours per day of unpaid assistance, on average, for a person in the early-middle stage of PPA.
  • Must have access to a computer with adequate internet connection. Able to use a videoconferencing platform and receive email. Participants must be able to read, speak and understand English and have no uncorrectable vision or hearing deficits that might impede participation.
  • Aim 2:
  • Informal (family or friends) caregivers of persons living with PPA. Age 18 or over Providing at least 2 hours per day of unpaid assistance, on average, for a person in the early-middle stage of PPA.
  • Must have access to a computer with adequate internet connection. Able to use a videoconferencing platform and receive email. Must be able to read, speak and understand English and have no uncorrectable vision or hearing deficits that might impede participation.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mesulam Center for Cognitive Neurology and Alzheimer's Disease, Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Primary Progressive Aphasia (PPA) Tele-Savvy: A Pilot Study of an Online Intervention for Caregivers of Persons Living With PPA

The primary goal of this pilot project is to adapt an evidence-informed on-line psychoeducation program (Tele-Savvy) to address the unique challenges facing informal caregivers of those living with PPA and geared toward achieving caregiver mastery in this population.

Read the detailed description

The primary goal of this pilot project is to develop an evidence-informed on-line psychoeducation program (Tele-Savvy) based on the well-established Savvy Caregiver program to address the unique challenges facing informal caregivers of those living with Primary Progressive Aphasia (PPA) and to help these caregivers achieve mastery. Key elements of the adaptation process are to identify and adapt mechanistic elements of the Tele-Savvy intervention (increasing self-efficacy, mastery of new skills, increased knowledge of disease-specific symptoms and trajectories, problem-solving skills). We will engage PPA caregivers in the process of adapting the existing Tele-Savvy program to fit their needs and then pilot test the adapted PPA Tele-Savvy program.

Being tested
PPA Tele-Savvy Pilot Intervention
Medical subject headings
Aphasia, Primary Progressive, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PPA Tele-Savvy Pilot InterventionBehavioural

    We will engage PPA caregivers in the process of adapting the existing Tele-Savvy program to fit their needs and then pilot test the adapted PPA Tele-Savvy program.

Study groups in NCT04412083
Study groupRoleWhat they receive
PPA Tele-Savvy Pilot InterventionOtherThe Tele-Savvy program is comprised of weekly, two-hour interactive classes, over seven consecutive weeks, the same duration as the proposed intervention. Tele-Savvy consists of educational instruction, video and in-class exercises that engage participants on a functional level. Course material was designed to provide informal caregivers with the knowledge, skills, and attitude needed to carry out their role as a caregiver for a person living with dementia (PLWD). Course learning objectives include: 1) introduction to dementing disorder; 2) caregiver self-care; 3) the anchors of contented involvement; 4) levels of thinking and performance; 5) strengthening the family as a resource for caregiving; and 6) review and integration of the previous sections.
Receives: Behavioral: PPA Tele-Savvy Pilot Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Caregiver Mastery Pearlin Caregiver Stress Scale Score

    Comprised of 6 domains from the full Pearlin Stress Scale. 1. Relational Deprivation: 6-24, higher scores indicate increased relational deprivation. 2. Role Captivity: 3 - 12, higher scores indicate an increased feeling of being trapped in the caregiver role. 3. Loss of Self: 2 - 8, higher scores indicate a greater loss of self. 4. Caregiving competence: 4 - 16, higher scores indicate greater caregiving competence. 5. Management of Situation: 4 - 16, higher scores indicate better management of the caregiving situation. 6. Management of Meaning: 9 - 36, higher scores indicate a better management of the meaning of the caregiving role.

    Measured: Baseline, 6-week follow-up

Secondary outcomes (6)

  1. Change in Caregiver Depression Center for Epidemiologic Studies Depression Scale (CES-D)

    A 20-item scale that represents a symptom cluster consisting of negative affect, positive affect, interpersonal problems, and somatic activity based on feelings over the past week.Scores range 0 - 60. A score of 0-16 indicates little to no symptomatology, a score of 16 or more indicates depression with higher scores indicating increased severity.

    Measured: Baseline, 6-week follow-up

  2. Change in Caregiver Burden The Zarit Burden Interview score

    The interview was developed to measure subjective burden among caregivers of adults with dementia. The 22-item self-report inventory examines burden associated with functional/behavioral impairments and the home care situation. The items are worded subjectively, focusing on the affective response of the caregiver. Scores range 0 - 88. Lower scores indicate little to no burden. Higher scores indicate greater burden. A score of 17 or more is considered high burden.

    Measured: Baseline, 6-week follow-up

  3. Change in Caregiver Stress Perceived Stress Survey score

    This questionnaire is comprised of 10 items from the Perceived Stress Scale. Scores range 0 - 40. Higher scores indicating higher perceived stress. A score of 0-13 would be considered low stress. Scores from 14-26 would be considered moderate stress. Scores from 27-40 indicate high perceived stress.

    Measured: Baseline, 6-week follow-up

  4. Change in Positive Aspects of Caregiving (PCOS) Scale score

    Caregivers will be instructed that "In spite of all the difficulties involved in giving care to a family member with memory or health problems, good things can come out of caregiving experiences." The scale has 11 items, and overall scores range 0 - 44. Higher scores indicate a more positive view of the caregiving role while lower scores indicate less positive views of the caregiver role.

    Measured: Baseline, 6-week follow-up

  5. Change in Care recipient quality of life DEMQOL: Dementia Quality of Life Measure (Carer v4) score

    This 32 item questionnaire will be used to assess mood, cognitive status, and overall quality of life of the care recipient. Scores range 31 - 124. Lower scores indicate no subjective concerns about cognition or general health, while higher scores indicate a greater subjective concern about cognition and general health.

    Measured: Baseline, 6-week follow-up

  6. Change in Behavioral and Psychological Symptoms of Dementia Revised Memory and Behavior Problem Checklist (RMBPC) score

    This 24 item instrument measures the frequency of the care recipient's problem behaviors in the following domains: disruptive behavior (wandering, aggression), memory-related behavior (repeating questions and stories), and depression. Scores range 0 - 96 for frequency. Lower scores indicate little to no behavioral problems while higher scores indicate greater behavioral issues. Scores range 0 - 96 for reaction. Lower scores indicate little concern regarding the behavior on the part of the caregiver while higher scores indicate greater concern.

    Measured: Baseline, 6-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2020
  2. Study start30 Jul 2020
  3. Primary completion19 Sep 2023
  4. Study completion19 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04412083
Sponsor's protocol ID
STU00210711
Status last verified
May 2024
First submitted
29 May 2020
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PPA Tele-Savvy Pilot Intervention in people with Primary Progressive Aphasia and Caregiver Burnout, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Caregiver Mastery Pearlin Caregiver Stress Scale Score (time frame: Baseline, 6-week follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04412083.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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