NCT01614340

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
658

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

May 22, 2012

Last Update Submit

August 15, 2018

Conditions

Arthritis - Post SurgicalOther Activity-limiting Pain

Keywords

Home careCognitive-Behavioral techniquesPhysical TherapyPainOlder Adults

Outcome Measures

Primary Outcomes (1)

  • Improvement on Performance-Based Measures of Functioning Among Intervention Patients

    Patients 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.

    Baseline/Intake and 60 day follow up

Secondary Outcomes (1)

  • Lower Rates of Service Utilization Within Intervention Group

    60 day follow up survey

Study Arms (2)

Usual Care

OTHER

Usual Physical Therapy Plan of Care

Behavioral: Cognitive-Behavioral Pain Self-management Program

Usual Care Plus Pain Management Program

OTHER

Behavioral: Cognitive-Behavioral Pain Self-management Program.

Behavioral: Cognitive-Behavioral Pain Self-management Program

Interventions

Cognitive-Behavioral Pain Self-management ProgramBEHAVIORAL

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.

Usual CareUsual Care Plus Pain Management Program

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Visiting Nurse Service of New York

New York, New York, 10001, United States

Location

Related Links

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher M Murtaugh, PhD

    Visiting Nurse Service of New York

    PRINCIPAL INVESTIGATOR

  • Cary Reid, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2012

First Posted

June 7, 2012

Study Start

October 1, 2012

Primary Completion

July 1, 2014

Study Completion

December 1, 2015

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

US(1)