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Treating Pain to Reduce Disability Among Older Home Health Patients

Treating Pain to Reduce Disability Among Older Home Health Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01614340
Enrollment
658
Registered
2012-06-07
Start date
2012-10-31
Completion date
2015-12-31
Last updated
2018-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis - Post Surgical, Other Activity-limiting Pain

Keywords

Home care, Cognitive-Behavioral techniques, Physical Therapy, Pain, Older Adults

Brief summary

The overall goal of this real-world comparative effectiveness research (CER) study is to reduce disability among older home health patients by treating their pain more effectively. To achieve this goal the investigators will conduct a cluster randomized controlled trial of a physical therapist (PT) delivered intervention provided to VNSNY home health care patients with activity-limiting pain. The intervention is an evidence-based non-pharmacological program to reduce pain and pain-related disability that utilizes cognitive-behavioral pain self-management (CBPSM) techniques.

Detailed description

This project will compare the effectiveness of usual care provided to older home health patients admitted with activity-limiting pain to usual care plus instruction by PTs in CBPSM techniques. The project also will examine differences in the effectiveness of the intervention among different race/ethnicity groups and individuals with different pain types, as well as the fidelity of intervention-group PTs to the CBPSM program. The specific aims of this CER study that will include sizeable numbers of Hispanics, non-Hispanic African Americans and non-Hispanic white patients ages 55 and older are: (1) to compare the effectiveness of usual care provided to older home health patients admitted with activity-limiting pain to usual care plus instruction by PTs in CBPSM techniques; and (2) to examine the heterogeneity of CBPSM treatment effects among patients with different pain conditions and minority group status.

Interventions

BEHAVIORALCognitive-Behavioral Pain Self-management Program

The main study intervention is training of the PTs on teams randomized into the intervention group in the evidence-based CBPSM program which has been translated for use in home health care with patients who have activity-limiting pain. The program is designed to be implemented in a manner that allows for maximal integration into routine PT care of home health patients. This will be possible because the CBPSM techniques, together with exercise and other PT techniques that constitute customary PT care, are reciprocally reinforcing. Both treatments (CBPSM and PT) encourage the use of similar behavioral and pain self-management coping skills to enhance behavioral activation, perceptions of self-efficacy, self-control, and personal mastery with regard to the management of pain.

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Weill Medical College of Cornell University
CollaboratorOTHER
Ithaca College
CollaboratorOTHER
Cornell University
CollaboratorOTHER
Visiting Nurse Service of New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* VNSNY patient in the adult home healthcare program * Services are being provided in the Bronx, Brooklyn, Manhattan, Queens, Staten Island, Nassau or Westchester * VNSNY Plan of Care includes physical therapy * Age 55 or older * Speaks English * Has a telephone * Activity-limiting pain

Exclusion criteria

* Significant cognitive impairment

Design outcomes

Primary

MeasureTime frameDescription
Improvement on Performance-Based Measures of Functioning Among Intervention PatientsBaseline/Intake and 60 day follow upPatients receiving usual care plus the intervention when compared with participants receiving usual care only will demonstrate (1) Significantly better results as measured by the Timed Up and Go test; Timed Chair Stands, and Timed Foot Taps test;(2) Significantly better ADL functioning;(3) Significantly reduced levels of pain-related disability as measured by the Roland Morris Disability Questionnaire; and (4) Significantly reduced levels of pain intensity and increased levels of pain relief as measured by the Brief Pain Inventory.

Secondary

MeasureTime frameDescription
Lower Rates of Service Utilization Within Intervention Group60 day follow up surveyPatients receiving the intervention plus usual care when compared to patients receiving usual care only will demonstrate significantly lower emergency department and hospital use during the follow-up period (as reported by the patient).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026