Life Story Questionnaire and Physical Therapy Participation

NCT ID: NCT05827276

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-26

Study Completion Date

2024-03-30

Brief Summary

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The goal of this clinical trial is to see the effect of life story questionnaire (LSQ) on physical therapy participation in patients with dementia. The main question\[s\] it aims to answer are:

1. What is the effect of LSQ usage on physical therapy participation in people with dementia?
2. What is the effect of LSQ usage on depression in people with dementia?
3. What is the effect of LSQ usage on the quality of life in people with dementia? The researcher will compare these effects between the intervention group (usage of the Life Story Questionnaire) and the control group (no usage of the Life story questionnaire).

All Participants will receive Physical therapy treatment as usual. The life Story Questionnaire will be used in the intervention group during physical therapy treatment.

Life Story Questionnaire: It is developed by the Crisis Prevention Institute, which is a type of life story book for people with dementia. The LSQ allows caregivers to start conversations about topics that are important to each patient, can help establish rapport between the caregiver and patient.

Detailed Description

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Background: Dementia is characterized by a progressive decline in cognitive function. Dementia disease prevalence is substantially increased among people aged 65 years or older, with a progressive decline in memory, thinking, language and learning capacity. Although physical exercise benefits dementia patients, participation in activities is exceedingly difficult due to communication and cognitive impairments. Several studies demonstrated that life story books usage improved quality of life, depression symptoms, moods and participation in activity in people with dementia. However, these studies did not evaluate the effect of Life Story Questionnaire (LSQ) - a type of life story book - on physical therapy participation, depression symptoms, quality of life.

Objectives: To evaluate the impact of LSQ on (1) participation in physical therapy using Pittsburgh Rehabilitation Participation Scale; (2) quality of life using Quality of Life - Alzheimer's Disease Scale (participant's version); and (3) depression symptoms using Cornell Scale for Depression in Dementia (CSDD).

Methods: A consecutive sample of convenience of up to 60 patients with mild to moderate cognitive impairment with 44 (22 per group) completing the study will be recruited from a nursing home facility. Patients will be randomly allocated in two groups: (1) Control group, which will receive standard physical therapy care without LSQ use; and (2) Experimental group, where physical therapists will use the LSQ. Each patient's family member will receive a LSQ to complete prior to the start of the intervention. Patients' participation, quality of life and depression symptoms will be measured on day 1 and again after 3 weeks (mid-term), and 6 weeks of intervention. Quality of life and depression symptoms will also be measured 6 weeks following intervention. A licensed occupational therapist blinded to the participants' group allocation will measure all three dependent variables

Statistical Analysis: Descriptive statistics including means, standard deviations, frequency counts, median, mode, variance and frequency counts will be used to assess sample demographics. The Rank Sum test will be used to assess differences in Pittsburgh Rehabilitation Participation Scale between the intervention and control group. Spearman Rank correlations will be used to determine the strength of the correlation between Mini-Mental state examination, Pittsburgh Rehabilitation Participation Scale and Quality of Life Alzheimer Disease.

Conditions

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Dementia Alzheimers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective Randomized Control Trial. Patients will be randomly allocated in two groups: (1) Control group, which will receive standard physical therapy care without LSQ use; and (2) Experimental group, where physical therapists will use the LSQ.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The outcome assessor will be blind to the usage of the life story questionnaire for study participants. Additionally, the participants will not be told the group they were allocated to.

Study Groups

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Usage of Life Story Questionnaire

This group will receive 6 weeks of physical therapy treatment as usual with the usage of the Life story questionnaire.

Group Type EXPERIMENTAL

Life story questionnaire

Intervention Type OTHER

Participant will receive physical therapy treatment as usual using information from Life Story Questionnaire.

No usage of Life Story Questionnaire

This group will receive 6 weeks of physical therapy treatment as usual with no usage of the Life Story Questionnaire.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Life story questionnaire

Participant will receive physical therapy treatment as usual using information from Life Story Questionnaire.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients residing at dementia facility in Texas;
2. Age 60-89 years;
3. Diagnosis of dementia disease, in mild to the moderate stage using the Mini-Mental State Examination (score between 10 -24) and
4. Attendance to physical therapy for 6 weeks.

Exclusion Criteria

1. Unable to speak English;
2. Blindness;
3. Deafness;
4. Mini-Mental State Examination score \>24 and
5. history of major psychiatric disorders such as schizophrenia and bipolar disorder requiring hospital admission within the last year.
Minimum Eligible Age

60 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas Tech University

OTHER

Sponsor Role collaborator

Texas Tech University Health Sciences Center

OTHER

Sponsor Role lead

Responsible Party

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Jean Michel Brismee

Principal co-investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Michel Brismee, ScD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center

Jonathan Singer, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University

Locations

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Peachtree Place (Dementia care facility)

Weatherford, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Megha S Shah, DPT

Role: CONTACT

770-2414526

Lisa Brite, OT

Role: CONTACT

817-3135179

Facility Contacts

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Megha Shah, DPT

Role: primary

770-241-4526

Lisa Brite, OT, BS

Role: backup

817-599-4181

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

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Other Identifiers

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IRB2023-103

Identifier Type: -

Identifier Source: org_study_id

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