Older AdultsNCT02905370
Progressing Home Health Rehabilitation for Older Adults
A study testing Progressive Multi-Component (PMC) in people with Older Adults and Physical Deconditioning, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This research study explores the effects of a progressive, multi-component intervention following a stay in the hospital or rehabilitation facility. The purpose of this research study is to compare a multi-component intervention (higher intensity exercise, nutritional supplementation, and greater emphasis on… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Older Adults, Physical Deconditioning
- What is being tested?
- Progressive Multi-Component (PMC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2016to 3 Jun 2022
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years of age and older
- Referred to home care physical therapy following acute medical deconditioning
- Have at least 3 comorbid conditions including those listed below:
- Chronic Obstructive Pulmonary Disease
- Gastrointestinal Bleed
- Urinary Tract Infection
Show all 28Show fewer
- Pneumonia
- Chronic ulcerative wounds
- Diabetes
- Hypertension
- Depression/mental health
- Irritable Bowel Syndrome
- Hernia
- Post-op pancreatic surgery
- Osteoporosis/OA/RA/Gout
- Heart Disease
- Hypercholesterolemia
- Peripheral Arterial Disease
- Spinal Stenosis
- Dehydration
- Syncope
- Atrial fibrillation
- Hypo/Hyperthyroid
- Renal Failure (no dialysis)
- Post-op bowel surgery
- Congestive Heart Failure
- Be ambulatory without human assistance prior to hospitalization
- Be English-speaking
Who cannot join
- Acute lower extremity fracture with weight-bearing restriction
- "Elective" joint replacement surgery
- Lower extremity amputation
- Acute cardiac surgery
- Terminal illness
- Active cancer treatment in which exercise is contraindicated
Show all 17Show fewer
- Deep vein thrombosis/pulmonary embolus (DVT/PE)
- Recent stroke (within 1 yr)
- Score of <20 on SLUMS (as of 08.16.2018, revised to exclusion #14)
- Inability to ambulate 10 feet without human assistance at time of hospital discharge
- Gait Speed <0.3m/s or >1.0 m/s
- Progressive neurodegenerative diagnosis (e.g. Parkinson's, MS, ALS)
- Use of illegal substances
- Clinical discretion of study physician to exclude patients who are determined to be unsafe and/or inappropriate to participate in high intensity rehabilitation as defined by the inclusion/exclusion criteria
- Active involvement of Adult Protection Services
- Current dialysis treatment
- Prisoners or those on probation or other alternative sentencing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver, Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Progressing Home Health Rehabilitation Paradigms for Older Adults
This research study explores the effects of a progressive, multi-component intervention following a stay in the hospital or rehabilitation facility. The purpose of this research study is to compare a multi-component intervention (higher intensity exercise, nutritional supplementation, and greater emphasis on functionally enhanced care transitions) with usual care physical therapy.
Read the detailed description
Declines in physical function as a result of acute illness are strongly and independently associated with a number of adverse health events for older adults. Home Health (HH) physical therapy may be the ideal venue for addressing these declines in physical function because around 3 million older adults receive HH services following discharge from acute or post-acute facilities. However, as currently structured, HH care does not appear to adequately restore function, as evidenced by poor long-term outcomes and high rates of hospital readmission. Diminished physical function has been particularly implicated as a risk factor for re-hospitalization --older adults with lower levels of ambulatory activity are 6 times more likely to be re-hospitalized than those with greater ambulatory activity. A more intensive approach to HH physical therapy for older adults has great potential to maximize physical function and reduce hospital readmissions. Therefore, the investigators have developed a high intensity home-based, progressive, interdisciplinary, multi-component (PMC) intervention that directly addresses the functional deficits seen after hospitalization. This intervention will include intensive rehabilitation, a care transitions program, and daily protein supplementation. The investigators will conduct a two-arm, randomized clinical trial (RCT) of 200 participants admitted to HH from an acute or post-acute facility. Participants will receive either 1) an intensive, PMC intervention using resistance exercise and evidenced-based motor control training to improve physical function, along with nutritional supplementation and emphasis on functionally enhanced care transitions or 2) usual care (UC) physical therapy. The primary goal of this investigation is to determine if PMC intervention, initiated upon admission to HH, improves physical function, as measured by performance and self-report assessments, more than UC physical therapy. The investigators will also examine the effects on fatigue, balance confidence, and activities of daily living. In an exploratory analysis, the effects of the PMC intervention on re-hospitalization rates, nursing home placement, emergency room visits, and falls after discharge from the acute care hospital will also be examined. All outcomes will be examined at baseline, 30, 60 (primary endpoint), 90 and 180 days. If successful in improving patient function and decreasing re-hospitalization rates, PMC intervention holds potential for future health care cost savings.
- Conditions
- Older Adults, Physical Deconditioning
- Being tested
- Progressive Multi-Component (PMC), Enhanced Usual Care (EUC)
- Keywords
- Home Health, Rehabilitation, High Intensity, Hospital Associated Deconditioning, Functional Mobility, Physical Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Multi-Component (PMC)Behavioural
Participants in the "Progressive Multi-component" intervention group will receive 1) high intensity physical therapy, 2) protein supplement, and 3) emphasis on functionally enhanced transitions of care following discharge from post-acute setting. High intensity physical therapy will include progressive resistance training, multi-planar motor control and gait exercises, and high intensity activities of daily living training. Functionally enhanced transitions of care protocol includes a personal health record with 5 domains that are addressed in an interdisciplinary manner with the patient. Participants will receive 12 intervention visits over 60 days. Participants will also receive a home exercise program.
Enhanced Usual Care (EUC)Behavioural
Participants in the "Enhanced Usual Care" group will receive standardized physical therapy following discharge from acute hospitalization. The activities of therapy will include basic strength training, single-planar motor control and gait exercises, and activities of daily living training. Participants will receive 12 intervention visits over 60 days. Participants will also receive a standardized home exercise program and standard nutritional education.
Name of Participant Arm updated to "Enhanced Usual Care" from "Usual Care" effective 8/16/18 to distinguish from Passive Comparator "True Usual Care" group.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Multi-Component (PMC) | Experimental | High intensity strength training protocol, daily protein supplementation, functionally enhanced transitions of care Receives: Behavioral: Progressive Multi-Component (PMC) |
| Enhanced Usual Care (EUC) | Active comparator | Low intensity rehabilitation protocol, standard education for nutrition, standard transitions of care
Name of Participant Arm updated to "Enhanced Usual Care" from "Usual Care" effective 8/16/18 to distinguish from Passive Comparator "True Usual Care" group. Receives: Behavioral: Enhanced Usual Care (EUC) |
| True Usual Care (TUC) | No intervention | Real-world home health rehabilitation, real-world education for nutrition, real-world transitions of care, non-randomized observation Participants in the "True Usual Care" group will receive physical therapy following discharge from acute hospitalization. Activities and number of visits are not protocolized and are provided by real world home health care providers per physician orders. Participant Arm added effective 8/16/18. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
SPPB is a well-accepted global measure of lower extremity function which consists of walking speed, chair stands, and balance. It is a well-studied composite measure and a strong predictor of disability, institutionalization, and morbidity in older adults. SPPB will also be assessed at 30, 90, 180 days post-randomization.
Measured: Change in SPPB from baseline to 60 days post randomization
Secondary outcomes (7)
Modified Physical Performance Test (mPPT)
mPPT assesses 7 tasks. Based on the time it takes to complete each task, a score from 0 (unable to complete) to 4 (performed quickly and easily) is given for each item. The maximal score is 28 and includes tasks that involve upper and lower extremity function. Test-retest reliability for the modified PPT score is 0.96. The instrument is sensitive to change and has been used in exercise trials with frail elders. mPPT will also be assessed at 30, 90, 180 days post-randomization.
Measured: Change in mPPT from baseline to 60 days post randomization
Fast walking speed (4MW)
Will be assessed at the fastest, safe speed for each participant over 4 meters. Fastest walking assesses capacity for performance of certain activities (e.g. crossing a street before the light changes). Fast walking speed will also be assessed at 30, 90, 180 days post-randomization.
Measured: Change in 4MW from baseline to 60 days post randomization
ActivPAL
Accelerometer-based physical activity examines volume and intensity of physical activity in which participants engage. Participants will wear a thigh-mounted activPAL physical activity monitoring device for up to 10 days to determine mean steps and activity counts per day (PAL Technologies, Glasgow, Scotland). Physical activity will also be defined as daily time spent in sitting, standing, and stepping. The activPAL has been found to be reliable (ICC≥0.99), valid (% Error =0.94% compared to video analysis; gold standard), and suitably sensitive to detect difference/change is similar populations. Physical activity will also be assessed at 30, 90, 180 days post-randomization.
Measured: Change in physical activity from baseline to 60 days post randomization
Falls Efficacy Scale-International
Questionnaire assesses concern about falling during performance of activities of daily living. Participants rate 16 individual activities on a scale from 1 (not at all concerned) to 4 (very concerned). Falls Efficacy Scale-International will also be assessed at 30, 90, 180 days post-randomization.
Measured: Change in Falls Efficacy Scale-International from baseline to 60 days post randomization
Fatigue Severity Scale (FSS)
A nine item questionnaire that quantifies the degree of fatigue and the impact of fatigue on activities of daily living in clinical populations. Participants score each of 9 components on a scale of 1 to 7. The aggregate score ranges from 9 (no impact) to 64 (profound impact of fatigue on activities of daily living). A total score of less than 36 suggests that a participant is not suffering from fatigue. The FSS is reliable (r=0.56-0.89), valid (α=0.97), and sensitive to change. FSS will also be assessed at 30, 90, 180 days post-randomization.
Measured: Change in FSS from baseline to 60 days post randomization
Patient Activation Measure (PAM)
Identifies patient motivation levels regarding their healthcare. Reliably predicts future ER visits, hospital admissions, and medication/ therapy adherence. The survey classifies patient activation levels on a scale from 1 (low activation/motivation) to 4 (high activation/motivation). Patients who score higher on the PAM survey tend to be hospitalized less and adhere to medication and therapy schedules more.
Measured: Change in PAM from baseline to 60 days post randomization
Grip Strength
Grip strength is a simple and reliable surrogate of overall muscle strength and a valid predictor of physical disability and mobility limitation. Grip strength will also be assessed at 30, 90, 180 days post-randomization.
Measured: Change in Grip Strength from baseline to 60 days post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start28 Sep 2016
- Primary completion6 May 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Arcadia University
- Responsible party
- Sponsor
- Investigators
- Jennifer E Stevens-Lapsley, MPT, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905370
- Sponsor's protocol ID
- 15-2125
- Other IDs
- R01NR016209
- Status last verified
- Mar 2024
- First submitted
- 14 Sep 2016
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cawood AL, Elia M, Stratton RJ. Systematic review and meta-analysis of the effects of high protein oral nutritional supplements. Ageing Res Rev. 2012 Apr;11(2):278-96. doi: 10.1016/j.arr.2011.12.008. Epub 2011 Dec 22.
PubMed 22212388Fisher SR, Kuo YF, Sharma G, Raji MA, Kumar A, Goodwin JS, Ostir GV, Ottenbacher KJ. Mobility after hospital discharge as a marker for 30-day readmission. J Gerontol A Biol Sci Med Sci. 2013 Jul;68(7):805-10. doi: 10.1093/gerona/gls252. Epub 2012 Dec 19.
PubMed 23254776Murkofsky RL, Alston K. The past, present, and future of skilled home health agency care. Clin Geriatr Med. 2009 Feb;25(1):1-17, v. doi: 10.1016/j.cger.2008.11.006.
PubMed 19217489Solomon DH, Wagner DR, Marenberg ME, Acampora D, Cooney LM Jr, Inouye SK. Predictors of formal home health care use in elderly patients after hospitalization. J Am Geriatr Soc. 1993 Sep;41(9):961-6. doi: 10.1111/j.1532-5415.1993.tb06762.x.
PubMed 8409182Timmer AJ, Unsworth CA, Taylor NF. Rehabilitation interventions with deconditioned older adults following an acute hospital admission: a systematic review. Clin Rehabil. 2014 Nov;28(11):1078-86. doi: 10.1177/0269215514530998. Epub 2014 May 20.
PubMed 24844238Garbin AJ, Falvey JR, Cumbler E, Derlein D, Currier D, Nordon-Craft A, Will R, Olivos M, Forster JE, Mangione KK, Stevens-Lapsley JE. Progressive Multicomponent Intervention for Older Adults in Home Health Settings Following Hospitalization: Randomized Clinical Trial. Phys Ther. 2024 Dec 6;104(12):pzae169. doi: 10.1093/ptj/pzae169.
PubMed 39704300Falvey JR, Mangione KK, Nordon-Craft A, Cumbler E, Burrows KL, Forster JE, Stevens-Lapsley JE. Progressive Multicomponent Intervention for Older Adults in Home Health Settings Following Acute Hospitalization: Randomized Clinical Trial Protocol. Phys Ther. 2019 Sep 1;99(9):1141-1149. doi: 10.1093/ptj/pzz069.
PubMed 31004493
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressing Home Health Rehabilitation Paradigms for Older Adults
- ClinicalTrials.gov ID
- NCT02905370
- Acronym / sponsor ID
- 15-2125
- Conditions
- Older Adults, Physical Deconditioning
- Keywords
- Home Health, Rehabilitation, High Intensity, Hospital Associated Deconditioning, Functional Mobility, Physical Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Arcadia University
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 19 Sep 2016 (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.
This research study explores the effects of a progressive, multi-component intervention following a stay in the hospital or rehabilitation facility. The purpose of this research study is to compare a multi-component intervention (higher intensity exercise, nutritional supplementation, and greater emphasis on functionally enhanced care transitions) with usual care physical therapy.
Detailed description
Declines in physical function as a result of acute illness are strongly and independently associated with a number of adverse health events for older adults. Home Health (HH) physical therapy may be the ideal venue for addressing these declines in physical function because around 3 million older adults receive HH services following discharge from acute or post-acute facilities. However, as currently structured, HH care does not appear to adequately restore function, as evidenced by poor long-term outcomes and high rates of hospital readmission. Diminished physical function has been particularly implicated as a risk factor for re-hospitalization --older adults with lower levels of ambulatory activity are 6 times more likely to be re-hospitalized than those with greater ambulatory activity. A more intensive approach to HH physical therapy for older adults has great potential to maximize physical function and reduce hospital readmissions. Therefore, the investigators have developed a high intensity home-based, progressive, interdisciplinary, multi-component (PMC) intervention that directly addresses the functional deficits seen after hospitalization. This intervention will include intensive rehabilitation, a care transitions program, and daily protein supplementation. The investigators will conduct a two-arm, randomized clinical trial (RCT) of 200 participants admitted to HH from an acute or post-acute facility. Participants will receive either 1) an intensive, PMC intervention using resistance exercise and evidenced-based motor control training to improve physical function, along with nutritional supplementation and emphasis on functionally enhanced care transitions or 2) usual care (UC) physical therapy. The primary goal of this investigation is to determine if PMC intervention, initiated upon admission to HH, improves physical function, as measured by performance and self-report assessments, more than UC physical therapy. The investigators will also examine the effects on fatigue, balance confidence, and activities of daily living. In an exploratory analysis, the effects of the PMC intervention on re-hospitalization rates, nursing home placement, emergency room visits, and falls after discharge from the acute care hospital will also be examined. All outcomes will be examined at baseline, 30, 60 (primary endpoint), 90 and 180 days. If successful in improving patient function and decreasing re-hospitalization rates, PMC intervention holds potential for future health care cost savings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Progressive Multi-Component (PMC) | Experimental | Behavioral: Progressive Multi-Component (PMC)High intensity strength training protocol, daily protein supplementation, functionally enhanced transitions of care |
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhanced Usual Care (EUC)Low intensity rehabilitation protocol, standard education for nutrition, standard transitions of care Name of Participant Arm updated to "Enhanced Usual Care" from "Usual Care" effective 8/16/18 to distinguish from Passive Comparator "True Usual Care" group. |
| True Usual Care (TUC) | No intervention | –Real-world home health rehabilitation, real-world education for nutrition, real-world transitions of care, non-randomized observation Participants in the "True Usual Care" group will receive physical therapy following discharge from acute hospitalization. Activities and number of visits are not protocolized and are provided by real world home health care providers per physician orders. Participant Arm added effective 8/16/18. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (28 listed)
- 65 years of age and older
- Referred to home care physical therapy following acute medical deconditioning
- Have at least 3 comorbid conditions including those listed below:
- Be ambulatory without human assistance prior to hospitalization
- Be English-speaking
Key exclusion criteria (17 listed)
- Acute lower extremity fracture with weight-bearing restriction
- "Elective" joint replacement surgery
- Lower extremity amputation
- Acute cardiac surgery
- Terminal illness
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 |
|---|---|---|
| Progressive Multi-Component (PMC)Participants in the "Progressive Multi-component" intervention group will receive 1) high intensity physical therapy, 2) protein supplement, and 3) emphasis on functionally enhanced transitions of care following discharge from post-acute setting. High intensity physical therapy will include progressive resistance training, multi-planar motor control and gait exercises, and high intensity activities of daily living training. Functionally enhanced transitions of care protocol includes a personal health record with 5 domains that are addressed in an interdisciplinary manner with the patient. Participants will receive 12 intervention visits over 60 days. Participants will also receive a home exercise program. | Behavioural | Progressive Multi-Component (PMC) |
| Enhanced Usual Care (EUC)Participants in the "Enhanced Usual Care" group will receive standardized physical therapy following discharge from acute hospitalization. The activities of therapy will include basic strength training, single-planar motor control and gait exercises, and activities of daily living training. Participants will receive 12 intervention visits over 60 days. Participants will also receive a standardized home exercise program and standard nutritional education. Name of Participant Arm updated to "Enhanced Usual Care" from "Usual Care" effective 8/16/18 to distinguish from Passive Comparator "True Usual Care" group. | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: Change in SPPB from baseline to 60 days post randomization
SPPB is a well-accepted global measure of lower extremity function which consists of walking speed, chair stands, and balance. It is a well-studied composite measure and a strong predictor of disability, institutionalization, and morbidity in older adults. SPPB will also be assessed at 30, 90, 180 days post-randomization.
7 secondary outcomes
Modified Physical Performance Test (mPPT)
Time frame: Change in mPPT from baseline to 60 days post randomization
Fast walking speed (4MW)
Time frame: Change in 4MW from baseline to 60 days post randomization
ActivPAL
Time frame: Change in physical activity from baseline to 60 days post randomization
Falls Efficacy Scale-International
Time frame: Change in Falls Efficacy Scale-International from baseline to 60 days post randomization
Fatigue Severity Scale (FSS)
Time frame: Change in FSS from baseline to 60 days post randomization
Patient Activation Measure (PAM)
Time frame: Change in PAM from baseline to 60 days post randomization
Grip Strength
Time frame: Change in Grip Strength from baseline to 60 days post randomization
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 7 Mar 2024.
- Background: PubMed 22212388Cawood AL, Elia M, Stratton RJ. Systematic review and meta-analysis of the effects of high protein oral nutritional supplements. Ageing Res Rev. 2012 Apr;11(2):278-96. doi: 10.1016/j.arr.2011.12.008. Epub 2011 Dec 22.
- Background: PubMed 23254776Fisher SR, Kuo YF, Sharma G, Raji MA, Kumar A, Goodwin JS, Ostir GV, Ottenbacher KJ. Mobility after hospital discharge as a marker for 30-day readmission. J Gerontol A Biol Sci Med Sci. 2013 Jul;68(7):805-10. doi: 10.1093/gerona/gls252. Epub 2012 Dec 19.
- Background: PubMed 19217489Murkofsky RL, Alston K. The past, present, and future of skilled home health agency care. Clin Geriatr Med. 2009 Feb;25(1):1-17, v. doi: 10.1016/j.cger.2008.11.006.
- Background: PubMed 8409182Solomon DH, Wagner DR, Marenberg ME, Acampora D, Cooney LM Jr, Inouye SK. Predictors of formal home health care use in elderly patients after hospitalization. J Am Geriatr Soc. 1993 Sep;41(9):961-6. doi: 10.1111/j.1532-5415.1993.tb06762.x.
- Background: PubMed 24844238Timmer AJ, Unsworth CA, Taylor NF. Rehabilitation interventions with deconditioned older adults following an acute hospital admission: a systematic review. Clin Rehabil. 2014 Nov;28(11):1078-86. doi: 10.1177/0269215514530998. Epub 2014 May 20.
- Derived from this study: PubMed 39704300Garbin AJ, Falvey JR, Cumbler E, Derlein D, Currier D, Nordon-Craft A, Will R, Olivos M, Forster JE, Mangione KK, Stevens-Lapsley JE. Progressive Multicomponent Intervention for Older Adults in Home Health Settings Following Hospitalization: Randomized Clinical Trial. Phys Ther. 2024 Dec 6;104(12):pzae169. doi: 10.1093/ptj/pzae169.
- Derived from this study: PubMed 31004493Falvey JR, Mangione KK, Nordon-Craft A, Cumbler E, Burrows KL, Forster JE, Stevens-Lapsley JE. Progressive Multicomponent Intervention for Older Adults in Home Health Settings Following Acute Hospitalization: Randomized Clinical Trial Protocol. Phys Ther. 2019 Sep 1;99(9):1141-1149. doi: 10.1093/ptj/pzz069.
- Individual participant dataSharing planned: No
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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.
Jennifer E Stevens-Lapsley, MPT, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Multi-Component (PMC) in people with Older Adults and Physical Deconditioning, run by University of Colorado, Denver 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 28 inclusion and 17 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 7 Mar 2024. 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?
Short Physical Performance Battery (SPPB) (time frame: Change in SPPB from baseline to 60 days post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02905370, which also lists 7 linked publications.
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 7 Mar 2024.