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| Name | Class |
|---|---|
| University of Kentucky | OTHER |
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Heart failure is common in adults and is the most common hospital diagnosis in older adults. Patients with heart failure suffer numerous distressing symptoms daily. Although palliative care can improve suffering, rural-dwelling heart failure patients have poor access to specialized palliative care. The investigators propose to pilot test a tele-health palliative care intervention, PALL-HEART, in rural dwelling heart failure patients who live in Virginia and Kentucky.
Study specific objectives are:
Primary Aims:
Secondary:
acceptability of the intervention for future refinement and large scale testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational Control Group | No Intervention | Education provided for optional use | |
| Gentle Stretching and Education | Experimental | Gentle Stretching for 60 minutes twice weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentle Stretching | Behavioral | 60 minutes fo gentle stretching twice weekly for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart Failure Somatic Perception Scale Questionnaire | This questionnaire measures symptoms of heart failure - The 18-item Somatic Perception Scale asks participants how much they are bothered by 18 symptoms of heart failure in the past week using 5 response options ranging from 0 (I did not have the symptom) to 5 (extremely bothersome). Scores are summed, with higher values indicating higher symptom burden. Scores range from 0-90 with higher values indicating higher symptom burden. | 10 weeks |
| PROMIS questionnaire | This questionnaire screens for symptoms of depression. The 8-item questionnaire assesses self-reported negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation) in the past week. The questionnaire uses 5 response options ranging from 0 (never) to 5 (always). Scores are summed, with higher values indicating higher risk for depression. The total raw score is converted into a T-score. The T-score rescales the raw score into a standardized score. The final score is a standardized score with a mean of 50 and a standard deviation of 10. | 10 weeks |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | This questionnaire measures quality of life in people with heart failure. This questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, a summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Overall scores are transformed to a range of 0-100, in which higher scores reflect better health status. There are summary scores within the KCCQ and the overall summary score is created by the mean of Physical Limitation Score, Total Symptom Score, Quality of Life Score, and Social Limitation Score. | 10 weeks |
| The Resilience Scale | The Resilience Scale is a 25-item administered questionnaire that measures an individual's ability to adapt over time to stressors in life. Scores on the summated scale range from 25 to 175, with higher scores indicating higher resilience. All of the items are positively worded. Items are measured on a 7-point scale from 1(strongly disagree) to 7 (strongly agree). Responses are summed to produce a total score where a higher score indicates higher resilience. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28122885 | Background | Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. | |
| 26727546 |
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Data will be shared with investigators who request the dataset. No individual personal or HIPPA identifiers will be shared.
when data are analyzed and for 5 years.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 10 weeks |
| Self-Care for Heart Failure Index Questionnaire (SCHFI) | The Self-Care for Heart Failure Index Questionnaire (SCHFI) is a 39-item measure of heart failure self-care. The items range from never (1) to always (5). There are 3 subscales: maintenance scale, symptom perception, confidence scale, and management scale. All of the scales are scored in the same way and a total score is not computed. Separate scores for each scale are computed separately. In general, to standardize a scale score, 1) determine the maximum possible scale score, 2) subtract the number of items from the possible score, and 3) divide 100 by that result to identify a constant for that scale. To score the scale, sum item responses, subtract the number of items answered, and multiply by the constant.The higher the score, the greater the ability to care for heart failure symptoms within each subscale. | 10 weeks |
| Endurance | 2 step test - step alternating knees upward for 2 minutes | 10 weeks |
| upper body strength - we will measure bicep strength by the number of hand weight lifts | participants are instructed to perform as many arm curls as possible for 30 seconds | 10 weeks |
| lower body strength - we will measure quadricep strength by the number of times siting and standing in 30 seconds | participants are instructed to sit and then to stand as many times as possible in 30 seconds | 10 weeks |
| balance | stand on 1 leg for as long as possible | 10 weeks |
| Background |
| Ni H, Xu J. Recent Trends in Heart Failure-related Mortality: United States, 2000-2014. NCHS Data Brief. 2015 Dec;(231):1-8. |
| 15916924 | Background | Zambroski CH, Moser DK, Bhat G, Ziegler C. Impact of symptom prevalence and symptom burden on quality of life in patients with heart failure. Eur J Cardiovasc Nurs. 2005 Sep;4(3):198-206. doi: 10.1016/j.ejcnurse.2005.03.010. |
| 28705314 | Background | Rogers JG, Patel CB, Mentz RJ, Granger BB, Steinhauser KE, Fiuzat M, Adams PA, Speck A, Johnson KS, Krishnamoorthy A, Yang H, Anstrom KJ, Dodson GC, Taylor DH Jr, Kirchner JL, Mark DB, O'Connor CM, Tulsky JA. Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial. J Am Coll Cardiol. 2017 Jul 18;70(3):331-341. doi: 10.1016/j.jacc.2017.05.030. |
| 27503067 | Background | Braun LT, Grady KL, Kutner JS, Adler E, Berlinger N, Boss R, Butler J, Enguidanos S, Friebert S, Gardner TJ, Higgins P, Holloway R, Konig M, Meier D, Morrissey MB, Quest TE, Wiegand DL, Coombs-Lee B, Fitchett G, Gupta C, Roach WH Jr; American Heart Association Advocacy Coordinating Committee. Palliative Care and Cardiovascular Disease and Stroke: A Policy Statement From the American Heart Association/American Stroke Association. Circulation. 2016 Sep 13;134(11):e198-225. doi: 10.1161/CIR.0000000000000438. Epub 2016 Aug 8. |
| 24815499 | Background | Dracup K, Moser DK, Pelter MM, Nesbitt TS, Southard J, Paul SM, Robinson S, Cooper LS. Randomized, controlled trial to improve self-care in patients with heart failure living in rural areas. Circulation. 2014 Jul 15;130(3):256-64. doi: 10.1161/CIRCULATIONAHA.113.003542. Epub 2014 May 9. |
| 28654302 | Background | Donesky D, Selman L, McDermott K, Citron T, Howie-Esquivel J. Evaluation of the Feasibility of a Home-Based TeleYoga Intervention in Participants with Both Chronic Obstructive Pulmonary Disease and Heart Failure. J Altern Complement Med. 2017 Sep;23(9):713-721. doi: 10.1089/acm.2015.0279. Epub 2017 Jun 27. |
| 16204405 | Background | Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687. |
| 10625273 | Background | Pope C, Ziebland S, Mays N. Qualitative research in health care. Analysing qualitative data. BMJ. 2000 Jan 8;320(7227):114-6. doi: 10.1136/bmj.320.7227.114. No abstract available. |
| Background | Martyn Hammersley. Challenging Relativism: The Problem of Assessment Criteria. Qual Inq. 2009 Jan 1;15(1):3-29. |
| Background | Clive Seale. Quality in Qualitative Research. Qual Inq. 1999 Dec 1;5(4):465-78 |