Total Knee Arthroplasty; Total Hip ArthroplastyNCT03443284
Health Partner Evaluation at Providence
A study testing Health Partner in people with Total Knee Arthroplasty; Total Hip Arthroplasty, run by DePuy Orthopaedics at 3 sites in United States.
Trial summary
This is a prospective, mixed methods, multi-center, randomized, comparative, controlled study. Providence Health \& Services will enroll a total of 296 subjects (18 years or older) who are electing to have total knee or hip replacement surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty; Total Hip Arthroplasty
- What is being tested?
- Health Partner
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Dec 2018to 17 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 or older at the time of consent.
- Subject must be identified by their PH \& S provider as needing elective unilateral TKA or THA.
- Subject is willing to give voluntary, written informed consent to participate in this Study prior to the scheduled TKA or THA surgery.
- Subject authorizes the transfer of his/her information to the Sponsor and Business Associate.
- Subject must have a valid e-mail address and willing to access their inbox on a regular basis.
- Subject must possess an iPhone/iPad/iPod Touch with operating iOS 9.0 or later and be willing to use and access digital materials from a mobile app.
- Subject must be able to comprehend and comply with the requirements of the Study.
- Subject must be able to speak, read and understand English fluently.
Who cannot join
- Subject is not able to follow the standard of care (e.g. due to allergies) and would require special care or circumstances.
- Subject scheduled to have TKA or THA sooner than 4 weeks from the time they enrolled in the study.
- Subject is undergoing a revision to a previous surgery.
- Subject is undergoing TKA or THA following traumatic injury (i.e. fracture).
- Subject is expected to need another lower limb joint replacement (hip/knee) prior to completing this Study.
- Subject is a repeat patient and was enrolled in the study previously.
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- Subject has had prior experience with the Health Partner companion app.
- Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- Subject, in the opinion of the sub-investigator is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect his/her ability to complete patient reported questionnaires or be compliant with follow-up requirements.
- Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
- Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Providence Newberg Medical Center
Newberg, Oregon, 97132
Providence Sacred Heart Hospital
Spokane, Washington, 99204
Providence Holy Family Hospital
Spokane, Washington, 99208
About this study
Official title: A Mixed Methods Randomized, Controlled Evaluation of Health Partner mHealth for Total Joint Replacement at Providence Health & Services
This is a prospective, mixed methods, multi-center, randomized, comparative, controlled study. Providence Health \& Services will enroll a total of 296 subjects (18 years or older) who are electing to have total knee or hip replacement surgery. Subjects will be randomized to either the treatment group (Health Partner alongside standard care) or the control group (standard care alone). Health Partner is a combination of an iPhone or iPod Touch Operating System mobile application and a health care provider portal. The primary objective is to compare care plan adherence (pre- and post-surgery) for Health Partner vs. control subjects. Secondary objectives include evaluating all-cause medical resource utilization, communication with health care provider, well-being, fear of surgery, confidence in recovery from surgery, sleep, and patient satisfaction for 90 days post-surgery. To evaluate the behavioral factors associated with care path adherence using a qualitative interview method.To evaluate the usability and preferences of patients in their interaction with the intervention using a qualitative interview method, for product development.
The total planned study duration is approximately 1 year and 7 months.
- Being tested
- Health Partner, Standard Care
- Keywords
- Total Knee Arthroplasty, Total Hip Arthroplasty, Total Knee Replacement, Total Hip Replacement, Hospital Care Plan, mHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health PartnerBehavioural
Also called mHealth
Health Partner is a combination of an iPhone or iPod Touch Operating System mobile application and a health care provider portal.
Standard CareBehavioural
Also called Control
Patients randomized to Control will receive pre-printed brochures that outline the steps of the care plan for unilateral TKA and THA, as per standard care provided to any unilateral TJA patient receiving care at Providence Health \& Services.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Health Partner) | Experimental | The mobile health (mHealth) product, Health Partner for Knees and Hips (Health Partner), is a combination of an iPhone or iPod Touch Operating System (iOS) mobile application (app) and a health care provider (HCP) portal. Receives: Behavioral: Health Partner |
| Control | Other | Patients randomized to Control will receive pre-printed brochures that outline the steps of the care plan for unilateral TKA and THA, as per standard care provided to any unilateral TJA patient receiving care at Providence Health \& Services. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care Path Behavioral Assessment (CPBA) Pre-surgery
Survey assesses degree of subject adherence with pre-surgical activities
Measured: Early post-operative (day after surgery to 6 weeks post-surgery)
Care Path Behavioral Assessment (CPBA), Post-surgery
Survey assesses degree of subject adherence with post-surgical activities
Measured: Late post-operative (11-13 weeks post surgery)
Secondary outcomes (10)
Medical Resource Utilization
Seven questions to evaluate the number and duration of encounters with the healthcare system after surgery
Measured: Late post-operative (11-13 weeks post-surgery)
Confidence in Recovery (1-item)
One question to guage subject's confidence in their recovery after surgery on a five-point Likert scale (ranging from Strongly disagree to Strongly sgree)
Measured: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery)
Fear of Surgery (1-item)
One question to guage degree to which subject is fearful of surgery on a five-point Likert scale (ranging from Strongly disagree to Strongly sgree)
Measured: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery)
Adherence (MOS Patient Adherence)
The Medical Outcomes Study (MOS) Patient Adherence is a 5-item questionnaire (ranging from "None of the time" to "All of the time") guaging subject self-reported ability to follow doctors' suggestions and the frequency of subject adherence. To score general adherence, the responses are averaged together after reversing items 1 and 3.
Measured: Pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery) and late post-operative (11-13 weeks post-surgery)
Well-being (MQLI)
The Multi-Cultural Quality of Life Index (MQLI) asks respondents to rank ten different areas of their life [self-care and independent functioning, occupational functioning, social-emotional support, community and service support, interpersonal functioning, global perception of quality of life, physical well-being, personal fulfillment, psychological/emotional well-being, and spiritual fulfillment] on a 10-point Likert scale
Measured: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery)
Well-being (PHS-WB)
The Public Health Surveillance Well-Being Scale (PHS-WB) comprises 10-items guaging self-reported mental, physical, and social components of well-being. Response options for 6 of the items are on a 5-point Likert-type scale. The responses options range from "strongly disagree" to "strongly agree," "none of the time" to "all of the time," and "poor" to "excellent." Three of the items are based on a 10-point Likert-type scale. Response options for the 10-point items range from "very dissatisfied" to "very satisfied." One item assesses energy/vitality over the past 30 day. The responses for that item ranged from 0 to 30. A score for the PHS-WB scale was created by summing the 10 items for each respondent.
Measured: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery)
Sleep (MOS Sleep Scale)
The MOS Sleep Scale is a 12-item instrument, which measures multiple facets of sleep. The MOS Sleep Scale yields a sleep problems index and six scale scores: sleep disturbance (have trouble falling asleep, how long to fall asleep, sleep was not quiet, awaken during your sleep time, and have trouble falling asleep again), sleep adequacy (get enough sleep to feel rested upon waking in the morning and get amount of sleep needed), daytime somnolence (drowsy during day, have trouble staying awake during the day, and take naps), snoring, awaken short of breath or with headache, and quantity of sleep. Quantity of sleep is scored as the average hours slept per night. The other scales and problems index are scored on a range from 0 to 100 with higher scores indicating more of the concept being measured.
Measured: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery)
Sleep (2-items)
Two questions to assess whether subjects had 7-9 hours of restful sleep per night
Measured: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery)
Communication (1-item)
One question to assess the frequency of subject's communication with their provider
Measured: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery)
Qualitative Interview
A qualitative interview to evaluate the behavioral factors associated with care path adherence and to evaluate the usability and preferences of patients in their interaction with the intervention, for product development.
Measured: Group 1: 1-7 days pre-surgery, Group 2: 7-10 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start11 Dec 2018
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Why it stopped: Business decision to close study due to low and slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty; Total Hip ArthroplastyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Health and Wellness Solutions, Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas Croy, MD, Principal investigator, Providence Newberg Medical CenterArnold Peterson, MD, Principal investigator, Providence Sacred Heart/Holy Family
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443284
- Sponsor's protocol ID
- DSJ-2017-06
- Status last verified
- Dec 2019
- First submitted
- 31 Jan 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed Methods Randomized, Controlled Evaluation of Health Partner mHealth for Total Joint Replacement at Providence Health & Services
- ClinicalTrials.gov ID
- NCT03443284
- Acronym / sponsor ID
- DSJ-2017-06
- Keywords
- Total Knee Arthroplasty, Total Hip Arthroplasty, Total Knee Replacement, Total Hip Replacement, Hospital Care Plan, mHealth
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision to close study due to low and slow enrollment.
- Enrolment
- 79 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Health and Wellness Solutions, Inc.
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 23 Feb 2018 (actual)
- 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.
This is a prospective, mixed methods, multi-center, randomized, comparative, controlled study. Providence Health \& Services will enroll a total of 296 subjects (18 years or older) who are electing to have total knee or hip replacement surgery. Subjects will be randomized to either the treatment group (Health Partner alongside standard care) or the control group (standard care alone). Health Partner is a combination of an iPhone or iPod Touch Operating System mobile application and a health care provider portal. The primary objective is to compare care plan adherence (pre- and post-surgery) for Health Partner vs. control subjects. Secondary objectives include evaluating all-cause medical resource utilization, communication with health care provider, well-being, fear of surgery, confidence in recovery from surgery, sleep, and patient satisfaction for 90 days post-surgery. To evaluate the behavioral factors associated with care path adherence using a qualitative interview method.To evaluate the usability and preferences of patients in their interaction with the intervention using a qualitative interview method, for product development.
The total planned study duration is approximately 1 year and 7 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Health Partner) | Experimental | Behavioral: Health PartnerThe mobile health (mHealth) product, Health Partner for Knees and Hips (Health Partner), is a combination of an iPhone or iPod Touch Operating System (iOS) mobile application (app) and a health care provider (HCP) portal. |
| Control | Other | Behavioral: Standard CarePatients randomized to Control will receive pre-printed brochures that outline the steps of the care plan for unilateral TKA and THA, as per standard care provided to any unilateral TJA patient receiving care at Providence Health \& Services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is 18 or older at the time of consent.
- Subject must be identified by their PH \& S provider as needing elective unilateral TKA or THA.
- Subject is willing to give voluntary, written informed consent to participate in this Study prior to the scheduled TKA or THA surgery.
- Subject authorizes the transfer of his/her information to the Sponsor and Business Associate.
- Subject must have a valid e-mail address and willing to access their inbox on a regular basis.
Key exclusion criteria (11 listed)
- Subject is not able to follow the standard of care (e.g. due to allergies) and would require special care or circumstances.
- Subject scheduled to have TKA or THA sooner than 4 weeks from the time they enrolled in the study.
- Subject is undergoing a revision to a previous surgery.
- Subject is undergoing TKA or THA following traumatic injury (i.e. fracture).
- Subject is expected to need another lower limb joint replacement (hip/knee) prior to completing this Study.
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 |
|---|---|---|
| Health PartnerAlso: mHealthHealth Partner is a combination of an iPhone or iPod Touch Operating System mobile application and a health care provider portal. | Behavioural | Intervention (Health Partner) |
| Standard CareAlso: ControlPatients randomized to Control will receive pre-printed brochures that outline the steps of the care plan for unilateral TKA and THA, as per standard care provided to any unilateral TJA patient receiving care at Providence Health \& Services. | Behavioural | Control |
Primary outcome
Care Path Behavioral Assessment (CPBA) Pre-surgery
Time frame: Early post-operative (day after surgery to 6 weeks post-surgery)
Survey assesses degree of subject adherence with pre-surgical activities
Care Path Behavioral Assessment (CPBA), Post-surgery
Time frame: Late post-operative (11-13 weeks post surgery)
Survey assesses degree of subject adherence with post-surgical activities
10 secondary outcomes
Medical Resource Utilization
Time frame: Late post-operative (11-13 weeks post-surgery)
Confidence in Recovery (1-item)
Time frame: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery)
Fear of Surgery (1-item)
Time frame: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery)
Adherence (MOS Patient Adherence)
Time frame: Pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery) and late post-operative (11-13 weeks post-surgery)
Well-being (MQLI)
Time frame: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery)
Well-being (PHS-WB)
Time frame: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery)
Sleep (MOS Sleep Scale)
Time frame: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery)
Sleep (2-items)
Time frame: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery)
Communication (1-item)
Time frame: Baseline (-6 to -3 weeks pre-surgery), pre-operative (-3 weeks to day before surgery), early post-operative (day after surgery to 6 weeks post-surgery), and late post-operative (11-13 weeks post-surgery)
Qualitative Interview
Time frame: Group 1: 1-7 days pre-surgery, Group 2: 7-10 weeks post-surgery
Results and safety
The study was stopped early (reason given: Business decision to close study due to low and slow enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
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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.
Thomas Croy, MD principal investigator
Providence Newberg Medical Center
Arnold Peterson, MD principal investigator
Providence Sacred Heart/Holy Family
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Partner in people with Total Knee Arthroplasty; Total Hip Arthroplasty, run by DePuy Orthopaedics at 3 sites 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 8 inclusion and 11 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: stopped early, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: Business decision to close study due to low and slow enrollment.). Results are not available in the source record.
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?
Care Path Behavioral Assessment (CPBA) Pre-surgery (time frame: Early post-operative (day after surgery to 6 weeks post-surgery)). The study lists 2 primary outcomes in all. 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 2 Jan 2020.