Arthritis - Post SurgicalNCT01614340
Treating Pain to Reduce Disability Among Older Home Health Patients
A study testing Cognitive-Behavioral Pain Self-management Program in people with Arthritis - Post Surgical and Other Activity-limiting Pain, run by Visiting Nurse Service of New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Arthritis - Post Surgical, Other Activity-limiting Pain
- What is being tested?
- Cognitive-Behavioral Pain Self-management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 658 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2015
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Visiting Nurse Service of New York
New York, New York, 10001
About this study
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.
Read the 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.
- Being tested
- Cognitive-Behavioral Pain Self-management Program
- Keywords
- Home care, Cognitive-Behavioral techniques, Physical Therapy, Pain, Older Adults
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Pain Self-management ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Other | Usual Physical Therapy Plan of Care Receives: Behavioral: Cognitive-Behavioral Pain Self-management Program |
| Usual Care Plus Pain Management Program | Other | Behavioral: Cognitive-Behavioral Pain Self-management Program. Receives: Behavioral: Cognitive-Behavioral Pain Self-management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline/Intake and 60 day follow up
Secondary outcomes (1)
Lower Rates of Service Utilization Within Intervention Group
Patients 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).
Measured: 60 day follow up survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis - Post SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 658 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visiting Nurse Service of New York
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Weill Medical College of Cornell University, Ithaca College, Cornell University
- Responsible party
- Sponsor
- Investigators
- Christopher M Murtaugh, PhD, Principal investigator, Visiting Nurse Service of New YorkCary Reid, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614340
- Sponsor's protocol ID
- 1R01HS020648-01A1
- Status last verified
- Aug 2018
- First submitted
- 22 May 2012
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Pain to Reduce Disability Among Older Home Health Patients
- ClinicalTrials.gov ID
- NCT01614340
- Acronym / sponsor ID
- 1R01HS020648-01A1
- Keywords
- Home care, Cognitive-Behavioral techniques, Physical Therapy, Pain, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 658 participants (actual)
- Lead sponsor
- Visiting Nurse Service of New YorkUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Weill Medical College of Cornell University, Ithaca College, Cornell University
- Study start
- Oct 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Other | Behavioral: Cognitive-Behavioral Pain Self-management ProgramUsual Physical Therapy Plan of Care |
| Usual Care Plus Pain Management Program | Other | Behavioral: Cognitive-Behavioral Pain Self-management ProgramBehavioral: Cognitive-Behavioral Pain Self-management Program. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Significant cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral Pain Self-management ProgramThe 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. | Behavioural | Usual Care, Usual Care Plus Pain Management Program |
Primary outcome
Improvement on Performance-Based Measures of Functioning Among Intervention Patients
Time frame: Baseline/Intake and 60 day follow up
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.
1 secondary outcome
Lower Rates of Service Utilization Within Intervention Group
Time frame: 60 day follow up survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher M Murtaugh, PhD principal investigator
Visiting Nurse Service of New York
Cary Reid, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Pain Self-management Program in people with Arthritis - Post Surgical and Other Activity-limiting Pain, run by Visiting Nurse Service of New York 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 17 Aug 2018. 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?
Improvement on Performance-Based Measures of Functioning Among Intervention Patients (time frame: Baseline/Intake and 60 day follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.