NCT03580915

Brief Summary

The purpose of this study is to assess a functional literacy program for formerly homeless adults now residing in supported housing who have difficulty performing daily life skills requiring functional literacy (e.g., bill paying, medication management, community transportation) needed to maintain housing placements. The hypothesis is that intervention group participants will improve in functional literacy compared to the control group that does not receive the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 24, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

June 25, 2018

Last Update Submit

January 14, 2019

Conditions

Keywords

functional literacyhomelessnessdaily life activities

Outcome Measures

Primary Outcomes (1)

  • Canadian Occupational Performance Measure (COPM) score

    The Canadian Occupational Performance Measure (COPM) is a 5-item, 10-point rating scale (1=most important, 10=least important) designed to be completed conjointly by a therapist and participant, and requires approximately 30 minutes to administer. The scale allows participants to identify and prioritize the most important problems impacting daily function and can be used with clients of all ages and diagnoses. Participants are asked to identify the five most critical problems impeding functional performance in the areas of self-care, productivity, and leisure. After the identification of five problems, participants are asked to rate both performance and satisfaction levels of the identified activities on a 10-point scale (1=not satisfied; 10=extremely satisfied). An open-ended narrative section is provided to allow therapists to record participant comments. The COPM is intended to be used pre- and post-intervention.

    1-week post-intervention

Secondary Outcomes (1)

  • Inventory of Reading Occupations (IRO) score

    1-week post-intervention

Study Arms (2)

Functional Literacy Intervention

EXPERIMENTAL

The intervention group will receive the functional literacy program in which, in small groups, participants learn literacy skills in the context of daily life activities such as shopping, meal preparation, and transportation use.

Behavioral: Functional Literacy ProgramBehavioral: Usual Care Management Services

Functional Literacy Control

ACTIVE COMPARATOR

The control group will not receive intervention but the Usual Care Management Services.

Behavioral: Usual Care Management Services

Interventions

The intervention will be provided twice weekly in 2-hour sessions, over 8 weeks. The 16 intervention sessions will provide the opportunity for participants to learn functional literacy skills to (1) manage an apartment, (2) access community resources, (3) manage finances, (4) access free recreational activities. All sessions will address literacy skills needed to complete basic daily life activities in the home and community environments. Literacy skills will first be learned and practiced within the supported shelter, and then extended to the community.

Functional Literacy Intervention

The control group will receive the usual housing services without additional intervention.

Functional Literacy ControlFunctional Literacy Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resident of a supported shelter environment (after homelessness)
  • Self-reported difficulty with basic reading skills needed to participate in desired daily life activities
  • English-speaking

You may not qualify if:

  • Severe behavioral management disorder that would make cooperation and direction following problematic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Sharon Gutman, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Approximately 10 participants will be randomly assigned to an intervention group; another 10 will be randomly assigned to a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Rehabilitation and Regenerative Medicine (Occupatio, Rehab & Regenerative Med OT)

Study Record Dates

First Submitted

June 25, 2018

First Posted

July 10, 2018

Study Start

September 24, 2018

Primary Completion

November 20, 2018

Study Completion

December 28, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations