Chronic DiseaseNCT02045147
Home Based Care Transitions Tailored by Cognition and Patient Activation
A study testing Grp 1a Low Cognition, Low Activation Intervention, Grp 2a Low Cognition, High Activation Intervention and Grp 3a Normal Cognition, Low Activation Intervention in people with Chronic Disease, run by University of Nebraska at 1 site in United States.
Trial summary
There is overwhelming evidence that patients with multiple chronic illnesses need better self-management skills. Discharge from the hospital may not be the most opportune time to be teaching patients these self-management skills. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Grp 1a Low Cognition, Low Activation Intervention, Grp 2a Low Cognition, High Activation Intervention and Grp 3a Normal Cognition, Low Activation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2013to 1 Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients (age 19 and older) being discharged from the hospital with three or more chronic diseases;
- Have a score greater than 17 on the Montreal Cognitive Assessment (dementia);
- Reside within a 35 mile radius of Lincoln, Ne.; and
- Able to hear, speak and read English.
Who cannot join
- Patients will be excluded if they:
- have a terminal illness;
- have a score of less than 17 on the Montreal Cognitive Assessment (dementia);
- are under the care of The Physicians Network (TPN) at St. Elizabeth Regional Medical Center (SERMC).
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510
About this study
Official title: Home Based Care Transitions Tailored by Cognition and Patient Activation: A Prudent Use of Transitional Care Resources
There is overwhelming evidence that patients with multiple chronic illnesses need better self-management skills. Discharge from the hospital may not be the most opportune time to be teaching patients these self-management skills. There are several different care transition models being used across the country; however we know that not every patient needs the same type or amount of an intervention. The purpose of this pilot study is to study the impact delivering a home based care transitions intervention (HBCTI) with four different groups tailored on cognition and level of patient activation compared to usual care (UC) resulting in 8 study arms on the outcomes of health care utilization (HCU) and health outcomes: patient-reported health status, assessment of care for chronic conditions, and health related quality of life in adult patients with multiple chronic diseases dismissed to home from an acute care facility. Our working hypothesis is that patients in the HBCTI groups compared to the UC groups will have lower HCU and improved outcomes (patient-reported health status, assessment of care for chronic conditions, and health related quality of life).
Read the detailed description
One in five Medicare patients discharged from the hospital experience readmission within 30 days. Too often, hospital readmissions result from inadequate transition from hospital to home at discharge. Care transitions are complicated because of high patient acuity, multiple comorbidities, decreased length of stay, and multiple clinician involvement increasing the number of handoffs. With decreased length of stay, many patients do not comprehend or feel confident with instructions for discharge, thus management of their chronic illnesses are difficult. Most formal care transition programs are standardized and every patient receives similar strategies or interventions. However, it has been well documented that patients with cognitive problems and decreased activation are at high risk for re-hospitalization related to impaired self-management. We believe that assessment of cognition and patient activation during the patient's hospitalization will provide valuable information for discharge interventions. Data related to cognition and activation can be used to tailor discharge planning and help determine what type and how many resources are needed for individual patients after hospital discharge. The purpose of this feasibility study is to examine the impact of delivering a home based care transitions interventions (HBCTIs) with four different groups tailored on cognition and level of patient activation compared to usual care (UC) on the outcomes of health care utilization (HCU) and health outcomes: patient-reported health status, assessment of care for chronic conditions, and health related quality of life in adult patients with multiple chronic diseases discharged to home from the hospital.
We will test our intervention with the following aims: Aim 1.To evaluate the impact of HBCTIs on health care utilization. We will measure HCU (number of emergency department(ED) visits and number of readmissions) at 6 months after discharge. Our working hypothesis is that patients in the HBCTI groups compared to the UC groups will have lower HCU over time (6 months); Aim 2. To evaluate the impact of HBCTIs on the following health outcomes: patient-reported health status (PROMIS-29), assessment of care for chronic conditions (PACIC), and quality of life (EuroQol). Our working hypothesis is that patients in the HBCTI groups compared to the UC group will have improved patient-reported health status, assessment of care for chronic conditions, and quality of life (EuroQol) at 6 months after discharge.
The findings from this study have the potential to change this paradigm in three ways: 1) we will gain a better understanding of the role of cognition and patient activation in promoting self-management to enhance outcomes; 2). our innovative approach, which considers the unique needs of patients based on their level of cognition and patient activation will advance new concepts in care transition programs; 3) we will have a better understanding of varying intensities of visits, level of providers, and type and amount of strategies administered. This practical model for care transitions could serve as a model within the larger health care delivery system that could result in significant cost savings.
- Conditions
- Chronic Disease
- Being tested
- Grp 1a Low Cognition, Low Activation Intervention, Grp 2a Low Cognition, High Activation Intervention, Grp 3a Normal Cognition, Low Activation Intervention, Grp 4a Normal Cognition, High Activation Intervention
- Keywords
- Home Bound Care Transitions
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grp 1a Low Cognition, Low Activation InterventionBehavioural
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Grp 2a Low Cognition, High Activation InterventionBehavioural
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Grp 3a Normal Cognition, Low Activation InterventionBehavioural
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Grp 4a Normal Cognition, High Activation InterventionBehavioural
The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
| Study group | Role | What they receive |
|---|---|---|
| Grp 1a: Low Cognition, Low Activation | Experimental | Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. Receives: Behavioral: Grp 1a Low Cognition, Low Activation Intervention |
| Grp 2a: Low Cognition, High Activation | Experimental | Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. Receives: Behavioral: Grp 2a Low Cognition, High Activation Intervention |
| Grp 3a: Normal Cognition, Low Activation | Experimental | Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. Receives: Behavioral: Grp 3a Normal Cognition, Low Activation Intervention |
| Grp 4a: Normal Cognition, High Activation | Experimental | Subjects will receive the least intensive intervention delivered by a RN coach. Receives: Behavioral: Grp 4a Normal Cognition, High Activation Intervention |
| Grp 1b: Low Cognition, Low Activation Usual Care | No intervention | Comparison group to 1a intervention group |
| Grp 2b Low Cognition, High Activation Usual Care | No intervention | Comparison group to 2a intervention group |
| Grp 3b: Normal Cognition, Low Activation Usual Care | No intervention | Comparison group to 3a intervention group |
| Grp 4b: Normal Cognition, High Activation Usual Care | No intervention | Comparison group to 4a intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Care Utilization
Patient report of number of Emergency Department Visits and number of re-admissions to the hospital within a 6 month time period was measured. Validation data was obtained from the clinical sites.
Measured: 6 months
Secondary outcomes (10)
Patient-Reported Outcomes Measurement Information System - Pain Interference
Pain interference is one of the 7 domains of the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS-29 is the shortest profile, with 4 questions asked for each of 7 domains, plus the single pain intensity item. PROMIS measures are scored on the T-score metric. Each short form is scored separately, yielding a total of 7 domain scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. There is no total score, but each axis forms its own score.
Assessing patient perception of pain interference is measured as a 4-item short form scale on the PROMIS-29 survey. Each item is scored from 1-5 with a 1 indicating "not at all" and 5 indicating "very much." The T-Score for the average general population is 50. Higher scores mean more pain interference, thus a worse outcome. A score change of 2-3 points has been reported as clinically meaningful differences.
Measured: 6 months
Patient-Reported Outcomes Measurement Information System-Physical Functioning
Physical Functioning is one of the 7 domains of the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS-29 is the shortest profile, with 4 questions asked for each of 7 domains, plus the single pain intensity item. PROMIS measures are scored on the T-score metric. Each short form is scored separately, yielding a total of 7 domain scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. There is no total score, but each axis forms its own score.
Physical functioning is measured as a 4-item short form subscale on the PROMIS-29 survey. The patients' answers to the Physical Functioning items are scored from 1-5, with a 1 indicating "unable to do" and 5 indicating "without any difficulty." Each subscales forms its own score subscale measures are scored on the T-score metric. High scores indicating better or higher physical functioning
Measured: 6 months after intervention
Patient-Reported Outcomes Measurement Information System-Satisfaction With Social Roles
Ability to participate in social roles and activities is one of the 7 domains of the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS-29 is the shortest profile, with 4 questions asked for each of 7 domains, plus the single pain intensity item. PROMIS measures are scored on the T-score metric. Each short form is scored separately, yielding a total of 7 domain scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. There is no total score, but each axis forms its own score.
Ability to participate in social roles and activities is measured as a 4-item short form subscale on the PROMIS-29 survey. The patients' answers to the PROMIS-29 are scored from 1-5, with a 1 indicating "never" and 5 indicating "always." Each subscales forms its own score subscale measures are scored on the T-score metric. High scores indicating more ability to participate in social roles and activities.
Measured: 6 months
Patient-Reported Outcomes Measurement Information System- Anxiety
Anxiety is one of the 7 domains of the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS-29 is the shortest profile, with 4 questions asked for each of 7 domains, plus the single pain intensity item. PROMIS measures are scored on the T-score metric. Each short form is scored separately, yielding a total of 7 domain scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. There is no total score, but each axis forms its own score.
Assessing patient anxiety is measured as a 4-item short form subscale on the PROMIS-29 survey. The patients' answers to the PROMIS-29 are scored from 1-5, with a 1 indicating "never" and 5 indicating "always." Each subscales forms its own score subscale measures are scored on the T-score metric. High scores indicating more anxiety and a worse outcome, and lower scores are indicative of less anxiety and a better outcome.
Measured: 6 months
Patient-Reported Outcomes Measurement Information System-Fatigue
Fatigue is one of the 7 domains of the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS-29 is the shortest profile, with 4 questions asked for each of 7 domains, plus the single pain intensity item. PROMIS measures are scored on the T-score metric. Each short form is scored separately, yielding a total of 7 domain scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. There is no total score, but each axis forms its own score.
Fatigue is measured as a 4-item short form subscale on the PROMIS-29 survey. The patients' answers to the PROMIS-29 are scored from 1-5, with a 1 indicating "not at all" and 5 indicating "very much." Each subscales forms its own score subscale measures are scored on the T-score metric. High scores indicating more fatigue and a worse outcome and lower scores are indicative of less fatigue and a better outcome.
Measured: 6 months
Patient-Reported Outcomes Measurement Information System- Depression
Depression is one of the 7 domains of the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS-29 is the shortest profile, with 4 questions asked for each of 7 domains, plus the single pain intensity item. PROMIS measures are scored on the T-score metric. Each short form is scored separately, yielding a total of 7 domain scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. There is no total score, but each axis forms its own score.
Depression is measured as a 4-item short form subscale on the PROMIS-29 survey. The patients' answers to the PROMIS-29 are scored from 1-5, with a 1 indicating "never" and 5 indicating "always." Each subscales forms its own score subscale measures are scored on the T-score metric. High scores indicating more feeling of depression and a worse outcome and lower scores are indicative of less depression and a better outcome.
Measured: 6 months
Patient-Reported Outcomes Measurement Information System-Sleep Deprivation
Sleep disturbance is one of the 7 domains of the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS-29 is the shortest profile, with 4 questions asked for each of 7 domains, plus the single pain intensity item. PROMIS measures are scored on the T-score metric. Each short form is scored separately, yielding a total of 7 domain scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. There is no total score, but each axis forms its own score.
Assessing sleep disturbance is measured as a 4-item short form subscale on the PROMIS-29 survey. The patients' answers to the sleep disturbance domain are scored from 1-5, with a 1 indicating "very good or very much" and 5 indicating "very poor or not at all." High scores indicating more sleep disturbance and a worse outcome, and lower scores are indicative of less sleep disturbance and a better outcome.
Measured: 6 months
Patient Assessment of Chronic Illness Care
The Patient Assessment of Chronic Illness Care (PACIC) Survey is a 20-item patient report instrument that assesses patient's receipt of clinical services and actions consistent with the Chronic Care Model. Respondents rate how often they experienced the content described in the item on a 5-point scale ranging from 1 (no or never) to 5 (yes or always). Patients rated the care received from their health care team. The PACIC consists of 5 scales and an overall summary score, each having good internal consistency for brief scales. The five subscales were Patient Activation; Delivery System/ Decision Support; Goal Setting; Problem-solving/Contextual Counseling; and Follow-up/ Coordination. Overall mean summary score (range 1-5) was used in analysis. Higher scores are more positive rating of their receipt of clinical services.
Measured: 6 months
Health Related Quality of Life EuroQol-5D (EQ-5D)
Quality of life was measured by the EuroQol-5 (EQ-5D) and consists of 1 question for each of the 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Patients indicate their health state for each of the 5 dimensions. The 5 responses give a health state represented by a 5-digit number (for example, 12231) corresponding to response categories reported by patients for the dimensions. Health states are scored to give the EQ-5D-5L index using a scoring algorithm from a value set derived from valuation tasks typically undertaken with general population samples. The five dimensions are combined into a 5-digit number that describes the patient's health state. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.
Measured: 6 months
EQ-5D Visual Analog Scale (VAS)
Used alongside the EuroQol-5D (EQ-5D), the EQ visual analog scale (VAS) is a 20 cm VAS "assessing your own health today" with endpoints labeled "Best imaginable health state" (100) and "Worst imaginable health state" (0). EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study start1 Oct 2013
- Primary completion1 Dec 2014
- Study completion1 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lani M Zimmerman, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045147
- Sponsor's protocol ID
- 0336-13-EP
- Status last verified
- Sep 2024
- First submitted
- 22 Jan 2014
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Based Care Transitions Tailored by Cognition and Patient Activation: A Prudent Use of Transitional Care Resources
- ClinicalTrials.gov ID
- NCT02045147
- Acronym / sponsor ID
- 0336-13-EP
- Conditions
- Chronic Disease
- Keywords
- Home Bound Care Transitions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 1 Dec 2014 (actual)
- Study completion
- 1 Dec 2014 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is overwhelming evidence that patients with multiple chronic illnesses need better self-management skills. Discharge from the hospital may not be the most opportune time to be teaching patients these self-management skills. There are several different care transition models being used across the country; however we know that not every patient needs the same type or amount of an intervention. The purpose of this pilot study is to study the impact delivering a home based care transitions intervention (HBCTI) with four different groups tailored on cognition and level of patient activation compared to usual care (UC) resulting in 8 study arms on the outcomes of health care utilization (HCU) and health outcomes: patient-reported health status, assessment of care for chronic conditions, and health related quality of life in adult patients with multiple chronic diseases dismissed to home from an acute care facility. Our working hypothesis is that patients in the HBCTI groups compared to the UC groups will have lower HCU and improved outcomes (patient-reported health status, assessment of care for chronic conditions, and health related quality of life).
Detailed description
One in five Medicare patients discharged from the hospital experience readmission within 30 days. Too often, hospital readmissions result from inadequate transition from hospital to home at discharge. Care transitions are complicated because of high patient acuity, multiple comorbidities, decreased length of stay, and multiple clinician involvement increasing the number of handoffs. With decreased length of stay, many patients do not comprehend or feel confident with instructions for discharge, thus management of their chronic illnesses are difficult. Most formal care transition programs are standardized and every patient receives similar strategies or interventions. However, it has been well documented that patients with cognitive problems and decreased activation are at high risk for re-hospitalization related to impaired self-management. We believe that assessment of cognition and patient activation during the patient's hospitalization will provide valuable information for discharge interventions. Data related to cognition and activation can be used to tailor discharge planning and help determine what type and how many resources are needed for individual patients after hospital discharge. The purpose of this feasibility study is to examine the impact of delivering a home based care transitions interventions (HBCTIs) with four different groups tailored on cognition and level of patient activation compared to usual care (UC) on the outcomes of health care utilization (HCU) and health outcomes: patient-reported health status, assessment of care for chronic conditions, and health related quality of life in adult patients with multiple chronic diseases discharged to home from the hospital.
We will test our intervention with the following aims: Aim 1.To evaluate the impact of HBCTIs on health care utilization. We will measure HCU (number of emergency department(ED) visits and number of readmissions) at 6 months after discharge. Our working hypothesis is that patients in the HBCTI groups compared to the UC groups will have lower HCU over time (6 months); Aim 2. To evaluate the impact of HBCTIs on the following health outcomes: patient-reported health status (PROMIS-29), assessment of care for chronic conditions (PACIC), and quality of life (EuroQol). Our working hypothesis is that patients in the HBCTI groups compared to the UC group will have improved patient-reported health status, assessment of care for chronic conditions, and quality of life (EuroQol) at 6 months after discharge.
The findings from this study have the potential to change this paradigm in three ways: 1) we will gain a better understanding of the role of cognition and patient activation in promoting self-management to enhance outcomes; 2). our innovative approach, which considers the unique needs of patients based on their level of cognition and patient activation will advance new concepts in care transition programs; 3) we will have a better understanding of varying intensities of visits, level of providers, and type and amount of strategies administered. This practical model for care transitions could serve as a model within the larger health care delivery system that could result in significant cost savings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Grp 1a: Low Cognition, Low Activation | Experimental | Behavioral: Grp 1a Low Cognition, Low Activation InterventionSubjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. |
| Grp 2a: Low Cognition, High Activation | Experimental | Behavioral: Grp 2a Low Cognition, High Activation InterventionSubjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. |
| Grp 3a: Normal Cognition, Low Activation | Experimental | Behavioral: Grp 3a Normal Cognition, Low Activation InterventionSubjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. |
| Grp 4a: Normal Cognition, High Activation | Experimental | Behavioral: Grp 4a Normal Cognition, High Activation InterventionSubjects will receive the least intensive intervention delivered by a RN coach. |
| Grp 1b: Low Cognition, Low Activation Usual Care | No intervention | –Comparison group to 1a intervention group |
| Grp 2b Low Cognition, High Activation Usual Care | No intervention | –Comparison group to 2a intervention group |
| Grp 3b: Normal Cognition, Low Activation Usual Care | No intervention | –Comparison group to 3a intervention group |
| Grp 4b: Normal Cognition, High Activation Usual Care | No intervention | –Comparison group to 4a intervention group |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult Patients (age 19 and older) being discharged from the hospital with three or more chronic diseases;
- Have a score greater than 17 on the Montreal Cognitive Assessment (dementia);
- Reside within a 35 mile radius of Lincoln, Ne.; and
- Able to hear, speak and read English.
Key exclusion criteria (4 listed)
- have a terminal illness;
- have a score of less than 17 on the Montreal Cognitive Assessment (dementia);
- are under the care of The Physicians Network (TPN) at St. Elizabeth Regional Medical Center (SERMC).
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 |
|---|---|---|
| Grp 1a Low Cognition, Low Activation InterventionThe intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation. | Behavioural | Grp 1a: Low Cognition, Low Activation |
| Grp 2a Low Cognition, High Activation InterventionThe intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations. | Behavioural | Grp 2a: Low Cognition, High Activation |
| Grp 3a Normal Cognition, Low Activation InterventionThe intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals. | Behavioural | Grp 3a: Normal Cognition, Low Activation |
| Grp 4a Normal Cognition, High Activation InterventionThe intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized. | Behavioural | Grp 4a: Normal Cognition, High Activation |
Primary outcome
Health Care Utilization
Time frame: 6 months
Patient report of number of Emergency Department Visits and number of re-admissions to the hospital within a 6 month time period was measured. Validation data was obtained from the clinical sites.
10 secondary outcomes
Patient-Reported Outcomes Measurement Information System - Pain Interference
Time frame: 6 months
Patient-Reported Outcomes Measurement Information System-Physical Functioning
Time frame: 6 months after intervention
Patient-Reported Outcomes Measurement Information System-Satisfaction With Social Roles
Time frame: 6 months
Patient-Reported Outcomes Measurement Information System- Anxiety
Time frame: 6 months
Patient-Reported Outcomes Measurement Information System-Fatigue
Time frame: 6 months
Patient-Reported Outcomes Measurement Information System- Depression
Time frame: 6 months
Patient-Reported Outcomes Measurement Information System-Sleep Deprivation
Time frame: 6 months
Patient Assessment of Chronic Illness Care
Time frame: 6 months
Health Related Quality of Life EuroQol-5D (EQ-5D)
Time frame: 6 months
EQ-5D Visual Analog Scale (VAS)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Lani M Zimmerman, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grp 1a Low Cognition, Low Activation Intervention, Grp 2a Low Cognition, High Activation Intervention and Grp 3a Normal Cognition, Low Activation Intervention in people with Chronic Disease, run by University of Nebraska 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 4 inclusion and 4 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 8 Oct 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?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Health Care Utilization (time frame: 6 months). 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 8 Oct 2024.