End-Stage Renal DiseaseTASCCINCT03440853
Technology Assisted Stepped Collaborative Care Intervention
A study testing TASCCI and Technology Delivered Health Education Intervention in people with End-Stage Renal Disease and Hemodialysis, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study evaluates a collaborative care intervention in reducing depression, fatigue and pain symptoms and improving health related quality of life in hemodialysis patients. Half of participants will receive the collaborative care intervention, while the other half will receive technology delivered health education… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease, Hemodialysis
- What is being tested?
- TASCCI and Technology Delivered Health Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2018to 30 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- undergoing thrice-weekly maintenance hemodialysis for > 3 months
- English speaking
- able to provide informed consent
- no evidence of thought disorder, delusions or active suicidal ideation
Who cannot join
- thought disorder, delusions or active suicidal ideation
- active substance abuse
- too ill or cognitively impaired to participate based on clinicians' judgment
- anticipated life expectancy of less than 1 year
- unable or unwilling to adhere to study protocol
- participating in another clinical trial or taking an investigational drug
- scheduled for living donor kidney transplant within next 6 months
- relocating to another dialysis unit within 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Technology Assisted Stepped Collaborative Care Intervention (TASCCI) to Improve Patient-centered Outcomes in Hemodialysis Patients
This study evaluates a collaborative care intervention in reducing depression, fatigue and pain symptoms and improving health related quality of life in hemodialysis patients. Half of participants will receive the collaborative care intervention, while the other half will receive technology delivered health education information.
Read the detailed description
End-stage renal disease patients on hemodialysis experience substantial symptom burden with fatigue, pain and depression among the most debilitating and existing as symptom clusters. These symptom clusters can exacerbate one another, and are independent and strong predictors of poor health-related quality of life in hemodialysis patients. This study will look at the effect of a 12 week stepped care intervention on changes in depression, pain or fatigue and health related quality of life.
- Conditions
- End-Stage Renal Disease, Hemodialysis
- Being tested
- TASCCI, Technology Delivered Health Education Intervention
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TASCCIBehavioural
TASCCI is a stepped-care collaborative care approach of pharmaco- and/or behavioral-therapy for a 12 week period. The intervention will target 1 or more symptoms based on patients' report of clinical levels of each symptom and patient preference. A trained behavioral therapist will deliver weekly video conferencing sessions during dialysis treatment.
Technology Delivered Health Education InterventionOther
The Technology Delivered Health Education Intervention will deliver weekly video conferencing sessions to deliver online educational material from the National Kidney Foundation. These sessions will be delivered by a care coordinator.
| Study group | Role | What they receive |
|---|---|---|
| TASCCI | Experimental | Patients randomized to TASCCI will receive a stepped-care approach of pharmaco and/or behavioral therapy for 12 weeks. The intervention will target 1 or more symptoms based on patients' report of clinical levels of each symptom and patient preference. Receives: Behavioral: TASCCI |
| Technology Delivered Health Education | Other | Patients randomized to the Technology Delivered Health Education Intervention health education group will receive technology delivered health education material on topics relevant to dialysis. Receives: Other: Technology Delivered Health Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression from baseline to 12 weeks
Depressive symptoms will be measured using the Beck Depression Inventory-II
Measured: Baseline and Post 12 week intervention
Change in pain from baseline to 12 weeks
Pain symptoms will be measured using the Brief Pain Inventory
Measured: Baseline and Post 12 week intervention
Change in fatigue from baseline to 12 weeks
Fatigue symptoms will be measured using the FACIT-F
Measured: Baseline and Post 12 week intervention
Secondary outcomes (3)
Change in adherence to medications
Adherence will be measured using the Medication Adherence Questionnaire (MAQ) Morisky Green Levine
Measured: Baseline, 3 month, 6 month, 12 month
Change in adherence to fluid restriction
Fluid restriction adherence will be determined by inter-dialytic weight gain percentage (of post dialysis weight over preceding 1 month) obtained by reviewing dialysis records. Those with IDWG% >3.5% will be classified as non-adherent
Measured: Baseline, 3 month, 6 month, 12 month
Change in adherence to hemodialysis treatments
Non-adherence with dialysis will be defined by the percentage of all dialysis sessions skipped and/or requested by the patient to be shortened by ≥ 10 minutes over the 12 week intervention period.
Measured: Baseline and Post 12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start28 Mar 2018
- Primary completion29 Apr 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Model description
- Patients will be randomized 1:1 to TASCCI or technology-delivered health education and undergo a 12-week intervention. Psychological and clinical outcomes will be collected at baseline, post intervention, 6 and 12 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of New Mexico
- Responsible party
- Principal investigator, Manisha Jhamb, University of Pittsburgh
- Investigators
- Manisha Jhamb, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440853
- Sponsor's protocol ID
- PRO17070630
- Other IDs
- 1R01DK114085-01
- Acronym
- TASCCI
- Status last verified
- Jul 2022
- First submitted
- 31 Jan 2018
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Erickson SJ, Yabes JG, Han Z, Roumelioti ME, Rollman BL, Weisbord SD, Steel JL, Unruh ML, Jhamb M. Associations between Social Support and Patient-Reported Outcomes in Patients Receiving Hemodialysis: Results from the TACcare Study. Kidney360. 2024 Jun 1;5(6):860-869. doi: 10.34067/KID.0000000000000456. Epub 2024 May 3.
PubMed 38704664Jhamb M, Steel JL, Yabes JG, Roumelioti ME, Erickson S, Devaraj SM, Vowles KE, Vodovotz Y, Beach S, Weisbord SD, Rollman BL, Unruh M. Effects of Technology Assisted Stepped Collaborative Care Intervention to Improve Symptoms in Patients Undergoing Hemodialysis: The TACcare Randomized Clinical Trial. JAMA Intern Med. 2023 Aug 1;183(8):795-805. doi: 10.1001/jamainternmed.2023.2215.
PubMed 37338898
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Assisted Stepped Collaborative Care Intervention (TASCCI) to Improve Patient-centered Outcomes in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03440853
- Acronym / sponsor ID
- TASCCI / PRO17070630
- Conditions
- End-Stage Renal Disease, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of New Mexico
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 22 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 study evaluates a collaborative care intervention in reducing depression, fatigue and pain symptoms and improving health related quality of life in hemodialysis patients. Half of participants will receive the collaborative care intervention, while the other half will receive technology delivered health education information.
Detailed description
End-stage renal disease patients on hemodialysis experience substantial symptom burden with fatigue, pain and depression among the most debilitating and existing as symptom clusters. These symptom clusters can exacerbate one another, and are independent and strong predictors of poor health-related quality of life in hemodialysis patients. This study will look at the effect of a 12 week stepped care intervention on changes in depression, pain or fatigue and health related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to TASCCI or technology-delivered health education and undergo a 12-week intervention. Psychological and clinical outcomes will be collected at baseline, post intervention, 6 and 12 months.
| Arm | Type | Receives |
|---|---|---|
| TASCCI | Experimental | Behavioral: TASCCIPatients randomized to TASCCI will receive a stepped-care approach of pharmaco and/or behavioral therapy for 12 weeks. The intervention will target 1 or more symptoms based on patients' report of clinical levels of each symptom and patient preference. |
| Technology Delivered Health Education | Other | Other: Technology Delivered Health Education InterventionPatients randomized to the Technology Delivered Health Education Intervention health education group will receive technology delivered health education material on topics relevant to dialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- undergoing thrice-weekly maintenance hemodialysis for > 3 months
- English speaking
- able to provide informed consent
- no evidence of thought disorder, delusions or active suicidal ideation
Key exclusion criteria (8 listed)
- thought disorder, delusions or active suicidal ideation
- active substance abuse
- too ill or cognitively impaired to participate based on clinicians' judgment
- anticipated life expectancy of less than 1 year
- unable or unwilling to adhere to study protocol
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 |
|---|---|---|
| TASCCITASCCI is a stepped-care collaborative care approach of pharmaco- and/or behavioral-therapy for a 12 week period. The intervention will target 1 or more symptoms based on patients' report of clinical levels of each symptom and patient preference. A trained behavioral therapist will deliver weekly video conferencing sessions during dialysis treatment. | Behavioural | TASCCI |
| Technology Delivered Health Education InterventionThe Technology Delivered Health Education Intervention will deliver weekly video conferencing sessions to deliver online educational material from the National Kidney Foundation. These sessions will be delivered by a care coordinator. | Other | Technology Delivered Health Education |
Primary outcome
Change in depression from baseline to 12 weeks
Time frame: Baseline and Post 12 week intervention
Depressive symptoms will be measured using the Beck Depression Inventory-II
Change in pain from baseline to 12 weeks
Time frame: Baseline and Post 12 week intervention
Pain symptoms will be measured using the Brief Pain Inventory
Change in fatigue from baseline to 12 weeks
Time frame: Baseline and Post 12 week intervention
Fatigue symptoms will be measured using the FACIT-F
3 secondary outcomes
Change in adherence to medications
Time frame: Baseline, 3 month, 6 month, 12 month
Change in adherence to fluid restriction
Time frame: Baseline, 3 month, 6 month, 12 month
Change in adherence to hemodialysis treatments
Time frame: Baseline and Post 12 week intervention
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 11 Jul 2022.
- Derived from this study: PubMed 38704664Erickson SJ, Yabes JG, Han Z, Roumelioti ME, Rollman BL, Weisbord SD, Steel JL, Unruh ML, Jhamb M. Associations between Social Support and Patient-Reported Outcomes in Patients Receiving Hemodialysis: Results from the TACcare Study. Kidney360. 2024 Jun 1;5(6):860-869. doi: 10.34067/KID.0000000000000456. Epub 2024 May 3.
- Derived from this study: PubMed 37338898Jhamb M, Steel JL, Yabes JG, Roumelioti ME, Erickson S, Devaraj SM, Vowles KE, Vodovotz Y, Beach S, Weisbord SD, Rollman BL, Unruh M. Effects of Technology Assisted Stepped Collaborative Care Intervention to Improve Symptoms in Patients Undergoing Hemodialysis: The TACcare Randomized Clinical Trial. JAMA Intern Med. 2023 Aug 1;183(8):795-805. doi: 10.1001/jamainternmed.2023.2215.
Related trials for End-Stage Renal Disease
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
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.
Manisha Jhamb, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TASCCI and Technology Delivered Health Education Intervention in people with End-Stage Renal Disease and Hemodialysis, run by University of Pittsburgh 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 5 inclusion and 8 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 11 Jul 2022. 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?
Change in depression from baseline to 12 weeks (time frame: Baseline and Post 12 week intervention). The study lists 3 primary outcomes in all. 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 NCT03440853, which also lists 2 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 11 Jul 2022.