Congestive Heart FailureNCT07356843
Palliative Care for People With HF
An observational study of Congestive Heart Failure and Congestive Heart Failure(CHF), run by Indiana University at 1 site in United States.
Trial summary
Imagine having heart failure, a condition where the heart struggles to pump blood, making daily life hard. People with heart failure often don't feel well and end up going to the hospital a lot. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Congestive Heart Failure(CHF), Congestive Heart Failure (CHF)
- What is being tested?
- ADAPT
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2025to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Outpatient clinician or staff member with at least 6 months of experience caring for patients with HF
Who may be able to join
- Outpatient clinician or staff member (e.g. physician, physician assistant, nurse practitioner, registered nurse, social worker, psychologist, medical assistant) or healthcare leadership personnel (e.g. Chief Nursing Officer, Clinic Medical Director etc.)
- at least 6 months of experience caring for patients with HF
- 18 years or older
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
IUHealth
Indianapolis, Indiana, 47408
Lyndsay DeGroot, PhD, RN, 317-278-7743, lydegroo@iu.edu
About this study
Official title: Implementing Community Palliative Care for People With Heart Failure
Imagine having heart failure, a condition where the heart struggles to pump blood, making daily life hard. People with heart failure often don't feel well and end up going to the hospital a lot. Many of these people could feel better with extra help, but there aren't many programs that offer support beyond usual heart failure treatments. That's where the ADAPT program comes in, which stands for "Advancing Symptom Alleviation with Palliative Treatment." In this program, nurses and social workers call people weekly, helping them manage their toughest symptoms, offering tools to cope with heart failure, and keeping the patients' current doctors involved. We tested this program in a research study with heart failure patients and found that it improved their quality of life and lowered depression, anxiety, and heart failure symptoms. The question now is if the ADAPT program will work in the community, outside of a research setting, so that more people could benefit from it. Specifically, can the ADAPT program work well in new places? Will patients and their families find it helpful? Most importantly, can it help improve the lives of people with heart failure in these new settings? To answer these questions, the study team will work with healthcare providers to 1) ask how to adjust the ADAPT program to work well in various settings (e.g. primary care, heart failure clinic) and 2) use this information to create simple materials and trainings to help them easily provide ADAPT. This will prepare for the next phase of this project to test out the new ADAPT program.
- Conditions
- Congestive Heart Failure, Congestive Heart Failure(CHF), Congestive Heart Failure (CHF), Congestive Heart Failure Chronic
- Being tested
- ADAPT
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAPTOther
Concurrent mixed methods design with rapid qualitative analysis of data from semi-structured interviews, structured clinic observations, and descriptive analysis of surveys. Participants will include clinical providers (e.g. physicians, advanced practice providers, nurses, social workers), staff, and leadership at IU Health. As opposed to traditional qualitative methods, rapid qualitative approaches are commonly used in implementation-focused research to guide real-time implementation processes.13 Findings will identify potential clinical partnership site(s) and inform selection and tailoring of strategies to implement ADAPT in a partner clinical site in the next stage of this project.
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Themes
Qualitative themes from interviews and clinic observations and descriptive summary statistics (e.g. means, percentages) of barriers and facilitators from pCAT and PCSI surveys.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start29 Oct 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lyndsay DeGroot, Indiana University
- Investigators
- Lyndsay DeGroot, PhD, RN, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356843
- Sponsor's protocol ID
- 28648
- Status last verified
- Jun 2026
- First submitted
- 13 Jan 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Qualitative interview data is often identifiable
Publications
Fernandez ME, Ten Hoor GA, van Lieshout S, Rodriguez SA, Beidas RS, Parcel G, Ruiter RAC, Markham CM, Kok G. Implementation Mapping: Using Intervention Mapping to Develop Implementation Strategies. Front Public Health. 2019 Jun 18;7:158. doi: 10.3389/fpubh.2019.00158. eCollection 2019.
PubMed 31275915Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1.
PubMed 25889199Gertner AK, Franklin J, Roth I, Cruden GH, Haley AD, Finley EP, Hamilton AB, Palinkas LA, Powell BJ. A scoping review of the use of ethnographic approaches in implementation research and recommendations for reporting. Implement Res Pract. 2021 Jan-Dec;2:2633489521992743. doi: 10.1177/2633489521992743. Epub 2021 Mar 16.
PubMed 34056611Kowalski CP, Nevedal AL, Finley EP, Young JP, Lewinski AA, Midboe AM, Hamilton AB. Planning for and Assessing Rigor in Rapid Qualitative Analysis (PARRQA): a consensus-based framework for designing, conducting, and reporting. Implement Sci. 2024 Oct 11;19(1):71. doi: 10.1186/s13012-024-01397-1.
PubMed 39394597Keniston A, McBeth L, Astik G, Auerbach A, Busch J, Kangelaris KN, Kulkarni SA, Linker AS, Sakumoto M, Leykum L, Burden M. Practical Applications of Rapid Qualitative Analysis for Operations, Quality Improvement, and Research in Dynamically Changing Hospital Environments. Jt Comm J Qual Patient Saf. 2023 Feb;49(2):98-104. doi: 10.1016/j.jcjq.2022.11.003. Epub 2022 Nov 7.
PubMed 36585315Gale RC, Wu J, Erhardt T, Bounthavong M, Reardon CM, Damschroder LJ, Midboe AM. Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans Health Administration. Implement Sci. 2019 Feb 1;14(1):11. doi: 10.1186/s13012-019-0853-y.
PubMed 30709368Vindrola-Padros C, Johnson GA. Rapid Techniques in Qualitative Research: A Critical Review of the Literature. Qual Health Res. 2020 Aug;30(10):1596-1604. doi: 10.1177/1049732320921835.
PubMed 32667277Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008 Apr;34(4):228-43. doi: 10.1016/s1553-7250(08)34030-6.
PubMed 18468362Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
PubMed 34593508Nevedal AL, Reardon CM, Opra Widerquist MA, Jackson GL, Cutrona SL, White BS, Damschroder LJ. Rapid versus traditional qualitative analysis using the Consolidated Framework for Implementation Research (CFIR). Implement Sci. 2021 Jul 2;16(1):67. doi: 10.1186/s13012-021-01111-5.
PubMed 34215286Bekelman DB, Feser W, Morgan B, Welsh CH, Parsons EC, Paden G, Baron A, Hattler B, McBryde C, Cheng A, Lange AV, Au DH. Nurse and Social Worker Palliative Telecare Team and Quality of Life in Patients With COPD, Heart Failure, or Interstitial Lung Disease: The ADAPT Randomized Clinical Trial. JAMA. 2024 Jan 16;331(3):212-223. doi: 10.1001/jama.2023.24035.
PubMed 38227034Chyr LC, DeGroot L, Waldfogel JM, Hannum SM, Sloan DH, Cotter VT, Zhang A, Heughan JA, Wilson RF, Robinson KA, Dy SM. Implementation and Effectiveness of Integrating Palliative Care Into Ambulatory Care of Noncancer Serious Chronic Illness: Mixed Methods Review and Meta-Analysis. Ann Fam Med. 2022 Jan-Feb;20(1):77-83. doi: 10.1370/afm.2754.
PubMed 35074772Bekelman DB, Rabin BA, Nowels CT, Sahay A, Heidenreich PA, Fischer SM, Main DS. Barriers and Facilitators to Scaling Up Outpatient Palliative Care. J Palliat Med. 2016 Apr;19(4):456-9. doi: 10.1089/jpm.2015.0280. Epub 2016 Mar 14.
PubMed 26974489Gelfman LP, Blum M, Ogunniyi MO, McIlvennan CK, Kavalieratos D, Allen LA. Palliative Care Across the Spectrum of Heart Failure. JACC Heart Fail. 2024 Jun;12(6):973-989. doi: 10.1016/j.jchf.2024.01.010. Epub 2024 Mar 6.
PubMed 38456852Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
PubMed 35363499
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Community Palliative Care for People With Heart Failure
- ClinicalTrials.gov ID
- NCT07356843
- Acronym / sponsor ID
- 28648
- Conditions
- Congestive Heart Failure, Congestive Heart Failure(CHF), Congestive Heart Failure (CHF), Congestive Heart Failure Chronic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 21 Jan 2026 (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.
Imagine having heart failure, a condition where the heart struggles to pump blood, making daily life hard. People with heart failure often don't feel well and end up going to the hospital a lot. Many of these people could feel better with extra help, but there aren't many programs that offer support beyond usual heart failure treatments. That's where the ADAPT program comes in, which stands for "Advancing Symptom Alleviation with Palliative Treatment." In this program, nurses and social workers call people weekly, helping them manage their toughest symptoms, offering tools to cope with heart failure, and keeping the patients' current doctors involved. We tested this program in a research study with heart failure patients and found that it improved their quality of life and lowered depression, anxiety, and heart failure symptoms. The question now is if the ADAPT program will work in the community, outside of a research setting, so that more people could benefit from it. Specifically, can the ADAPT program work well in new places? Will patients and their families find it helpful? Most importantly, can it help improve the lives of people with heart failure in these new settings? To answer these questions, the study team will work with healthcare providers to 1) ask how to adjust the ADAPT program to work well in various settings (e.g. primary care, heart failure clinic) and 2) use this information to create simple materials and trainings to help them easily provide ADAPT. This will prepare for the next phase of this project to test out the new ADAPT program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinician or staff member with at least 6 months of experience caring for patients with HF
Key inclusion criteria (3 listed)
- Outpatient clinician or staff member (e.g. physician, physician assistant, nurse practitioner, registered nurse, social worker, psychologist, medical assistant) or healthcare leadership personnel (e.g. Chief Nursing Officer, Clinic Medical Director etc.)
- at least 6 months of experience caring for patients with HF
- 18 years or older
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| ADAPTConcurrent mixed methods design with rapid qualitative analysis of data from semi-structured interviews, structured clinic observations, and descriptive analysis of surveys. Participants will include clinical providers (e.g. physicians, advanced practice providers, nurses, social workers), staff, and leadership at IU Health. As opposed to traditional qualitative methods, rapid qualitative approaches are commonly used in implementation-focused research to guide real-time implementation processes.13 Findings will identify potential clinical partnership site(s) and inform selection and tailoring of strategies to implement ADAPT in a partner clinical site in the next stage of this project. | Other | – |
Primary outcome
Qualitative Themes
Time frame: Baseline
Qualitative themes from interviews and clinic observations and descriptive summary statistics (e.g. means, percentages) of barriers and facilitators from pCAT and PCSI surveys.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 31275915Fernandez ME, Ten Hoor GA, van Lieshout S, Rodriguez SA, Beidas RS, Parcel G, Ruiter RAC, Markham CM, Kok G. Implementation Mapping: Using Intervention Mapping to Develop Implementation Strategies. Front Public Health. 2019 Jun 18;7:158. doi: 10.3389/fpubh.2019.00158. eCollection 2019.
- Background: PubMed 25889199Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1.
- Background: PubMed 34056611Gertner AK, Franklin J, Roth I, Cruden GH, Haley AD, Finley EP, Hamilton AB, Palinkas LA, Powell BJ. A scoping review of the use of ethnographic approaches in implementation research and recommendations for reporting. Implement Res Pract. 2021 Jan-Dec;2:2633489521992743. doi: 10.1177/2633489521992743. Epub 2021 Mar 16.
- Background: PubMed 39394597Kowalski CP, Nevedal AL, Finley EP, Young JP, Lewinski AA, Midboe AM, Hamilton AB. Planning for and Assessing Rigor in Rapid Qualitative Analysis (PARRQA): a consensus-based framework for designing, conducting, and reporting. Implement Sci. 2024 Oct 11;19(1):71. doi: 10.1186/s13012-024-01397-1.
- Background: PubMed 36585315Keniston A, McBeth L, Astik G, Auerbach A, Busch J, Kangelaris KN, Kulkarni SA, Linker AS, Sakumoto M, Leykum L, Burden M. Practical Applications of Rapid Qualitative Analysis for Operations, Quality Improvement, and Research in Dynamically Changing Hospital Environments. Jt Comm J Qual Patient Saf. 2023 Feb;49(2):98-104. doi: 10.1016/j.jcjq.2022.11.003. Epub 2022 Nov 7.
- Background: PubMed 30709368Gale RC, Wu J, Erhardt T, Bounthavong M, Reardon CM, Damschroder LJ, Midboe AM. Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans Health Administration. Implement Sci. 2019 Feb 1;14(1):11. doi: 10.1186/s13012-019-0853-y.
- Background: PubMed 32667277Vindrola-Padros C, Johnson GA. Rapid Techniques in Qualitative Research: A Critical Review of the Literature. Qual Health Res. 2020 Aug;30(10):1596-1604. doi: 10.1177/1049732320921835.
- Background: PubMed 18468362Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008 Apr;34(4):228-43. doi: 10.1016/s1553-7250(08)34030-6.
- Background: PubMed 34593508Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
- Background: PubMed 34215286Nevedal AL, Reardon CM, Opra Widerquist MA, Jackson GL, Cutrona SL, White BS, Damschroder LJ. Rapid versus traditional qualitative analysis using the Consolidated Framework for Implementation Research (CFIR). Implement Sci. 2021 Jul 2;16(1):67. doi: 10.1186/s13012-021-01111-5.
- Background: PubMed 38227034Bekelman DB, Feser W, Morgan B, Welsh CH, Parsons EC, Paden G, Baron A, Hattler B, McBryde C, Cheng A, Lange AV, Au DH. Nurse and Social Worker Palliative Telecare Team and Quality of Life in Patients With COPD, Heart Failure, or Interstitial Lung Disease: The ADAPT Randomized Clinical Trial. JAMA. 2024 Jan 16;331(3):212-223. doi: 10.1001/jama.2023.24035.
- Background: PubMed 35074772Chyr LC, DeGroot L, Waldfogel JM, Hannum SM, Sloan DH, Cotter VT, Zhang A, Heughan JA, Wilson RF, Robinson KA, Dy SM. Implementation and Effectiveness of Integrating Palliative Care Into Ambulatory Care of Noncancer Serious Chronic Illness: Mixed Methods Review and Meta-Analysis. Ann Fam Med. 2022 Jan-Feb;20(1):77-83. doi: 10.1370/afm.2754.
- Individual participant dataSharing planned: Undecided. Qualitative interview data is often identifiable
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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.
Lyndsay DeGroot, PhD, RN principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure and Congestive Heart Failure(CHF), run by Indiana University 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 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lyndsay DeGroot, PhD, RN (317-278-7743, lydegroo@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Themes (time frame: Baseline). 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 NCT07356843, which also lists 22 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 16 Jun 2026.