Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Feasibility of Intervention Delivery and Data Collection |
Proportion of participants who complete assigned intervention components and study-related assessments. |
Baseline and 12 weeks |
|
| Primary |
Acceptability of Intervention Measure (AIM) |
A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Minimum score is 4 and maximum is 20. Higher scores indicate a higher chance of acceptability. Lower scores indicate a lower chance of acceptability. |
12 weeks |
|
| Primary |
PROMIS Pain Intensity Scale |
Through PROMIS measures, we will explore reports on pain intensity. This includes a 3-item questionnaire on pain intensity and a 6-item question on pain interference over a week. Minimum score is 3 and the maximum score is 15. Higher values indicate higher pain intensity. Lower values indicate lower pain intensity. |
Baseline and 12 weeks |
|
| Primary |
Pain Interference Scale Short Form 6b |
A 6-item self-reported measure of the consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Minimum score is 6 and maximum score is 30. Higher scores indicate higher pain interference. Lower scores indicate lower pain interference. |
Baseline and 12 weeks |
|
| Primary |
Feasibility of Intervention Measure |
A 4-items scale that measures implementation outcomes that are often considered "leading indicators" of implementation success. Minimum score is 4 and maximum score is 20. Higher scores indicated higher feasibility and lower scores indicate less feasibility. |
12 weeks |
|
| Secondary |
Edmonton Symptom Assessment Scale (ESES-r) |
A 10-item measuring symptom burden. This tool measures symptom burden on the following domains: pain, tiredness, nausea, lack of appetite, shortness of breath, anxiety, depression, overall well-being and self-reported other problems. Minimum score is 0 and Maximum score is 100. Higher scores indicate more symptom burden. Lower scores indicate less symptom burden. |
Baseline and 12 weeks |
|
| Secondary |
Kansas City Cardiomyopathy Questionnaire- Short Form |
12 items total; Measures changes in the quality of life, 5 domains: physical limitations, symptoms, self-efficacy, social interference, and quality of life. Minimum score is 0 and Maximum score is 100. Higher scores indicated better quality of life. Lower scores indicate poorer quality of life. |
Baseline and 12 weeks |
|
| Secondary |
Hospital Anxiety and Depression Scale (HADS) |
14 items total, 7 items measure anxiety (e.g., feeling tense, restless, worry), 7 items measure depressive symptoms (e.g., cheerfulness, feeling slowed down). Minimum score is 0 and maximum score is 100. Higher scores indicate worse anxiety/depression. Lower scores indicate less depression and anxiety. |
Baseline and 12 weeks |
|
| Secondary |
PROMIS General Self-efficacy |
4 items measure self-efficacy (managing problems or events); Minimum score is 0 and maximum score is 100. Higher values indicates greater self-efficacy. Lower values indicate worse self-efficacy. |
Baseline & 12 weeks |
|
| Secondary |
Self-care of Heart Failure Index |
22 items; a measure of self-care defined as a naturalistic decision making process. Minimum score is 0 and Maximum score is 100. Higher scores indicate greater self-care adequacy. Lower scores indicate worse self-care adequacy. |
Baseline & 12 weeks |
|
| Secondary |
Multidimensional Scale of Perceived Social Support (MSPSS) |
12-items; 2-items; questionnaire to identify an individual's perceived level of social support with family, friends, and significant others. Minimum score is 12 and Maximum score is 84. Higher scores indicate greater perceived social support. Lower scores indicate lower perceived social support. |
Baseline & 12 weeks |
|
| Secondary |
Patient Activation Measure (PAM) Short Form |
3-items; assesses patient knowledge, skill, and confidence for self-management; not scored; categorical (disagree strongly- agree strongly. |
Baseline & 12 weeks |
|
| Secondary |
Brief Multidimensional Measure of Religiousness / Spirituality (BMMRS) - 6-item subscale for Religious/Spiritual Coping + 1 overall Q |
6-item subscale for Religious/Spiritual Coping + 1 overall Q 6-items; measure of religiousness/spirituality; Not scored; Categorical (A great deal- Not at all) |
Baseline & 12 weeks |
|
| Secondary |
Connor-Davidson Resilience Scale (CD-RISC-10) |
10-items; a unidimensional self-reported scale consisting measuring resilience. Minimum score is 0 and Maximum score is 100. Higher scores reflect great resilience Lower scores indicate worse resilience. |
Baseline & 12 weeks |
|
| Secondary |
Discrimination in Medical Settings Scale Scale |
17-items; measure of racial discrimination, scored as a mean. Higher means indicate more reports of racial discrimination in health care. Lower scores indicates lower reports of racial discrimination in healthcare settings. |
Baseline & 12 weeks |
|
| Secondary |
Cost/Resource Utilization Form |
5-items; Investigator-developed questions- 5 patient-report; 5 related to intervention delivery costs; not scored, more responses indicate receiving more healthcare services. |
Baseline & 12 weeks |
|
| Secondary |
SF Global Health Scale |
10-item scale measuring measure self-reported physical, mental and social health. Minimum score is 0 and maximum score is 100. Higher scores indicate better health. Lower scores indicate poorer health. |
Baseline & 12 weeks |
|
