EMPOwer: Equitable Mental Wellness Programming for Older Adults With Chronic Physical Conditions
Study Details
Study Description
Brief Summary
Chronic physical conditions are defined as conditions that require ongoing management and treatment over extended periods of time. Disproportionately impacting adults ≥50 years of age, chronic physical conditions are not only leading causes of death and disability in North America but they are commonly associated with mental distress and reduced quality of life. Online mind-body wellness programming ranging from physical activity to mindfulness interventions has been shown to be effective in improving mental wellness in a variety of chronic disease populations, but there is a need to evaluate scalable ways to deliver these programs. Building upon a previously developed online wellness program for inflammatory bowel disease (IBD) and primary biliary cholangitis (PBC), the research team has developed a mind-body wellness program for adults ≥50 years of age living with different chronic conditions (e.g., cirrhosis, PBC, heart failure). The 12-week program will be delivered online, and include follow- along mindful movement, breathwork and meditation routines, and a psychology based coping skills program. In a three-armed randomized controlled trial, the study will assess the impact on the primary outcome of anxiety and depression as measured through the hospital anxiety and depression scale (HADS). At the beginning and the end of the 12-week research study, participants will complete surveys to assess secondary/exploratory outcome measures including quality of life, fatigue, frailty, demoralization, and healthcare usage.
After the program, the research team will conduct interviews with participants to allow them to share their other feedback about the program. The researchers will also send surveys to the participants eight weeks after the program ends to assess longer- term impacts on primary and secondary outcomes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Waitlist Control
|
|
| Experimental: Online Program Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) |
Behavioral: Online mind-body wellness program
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program)
|
| Experimental: Online Program + Weekly Check-ins Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief 1-to-1 weekly check-ins with a study team member |
Behavioral: Online mind-body wellness program + Weekly Check-ins
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief weekly check-ins
|
Outcome Measures
Primary Outcome Measures
- Hospital Anxiety and Depression Scale (HADS) [12 weeks]
Depression and anxiety will be measured on the Hospital Anxiety and Depression Scale. The minimum value is 0, the maximum is 21, and higher scores mean a worse outcome.
Secondary Outcome Measures
- Modified Fatigue Impact Scale (MFIS) [12 weeks]
The Modified Fatigue Impact Scale (MFIS) assesses the effect of fatigue on cognitive functioning, physical functioning, and psychosocial functioning. The minimum value is 0, the maximum value is 84, and higher scores mean a worse outcome.
- Health Related Quality of Life [12 weeks]
Health related quality of life captured by the quality-of-life Short Form Survey 36 (SF-36). The minimum value is 0, the maximum value is 100, and a higher score means a better outcome.
- EQ-5D-5L [12 weeks]
Cost utility will be captured by the EQ-5D-5L which consists of 5- dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) where patients are asked to indicate their health state. The minimum value is 5, the maximum value is 25, and a higher score means a worse outcome.
- Capability, Opportunity, Motivation, Behaviour (COM-B) Survey [12 weeks]
Capability, opportunity, and motivation for behaviour change will be measured on the COM-B survey. The lowest score is 0, the highest score is 60, and higher scores indicate better outcomes.
- Satisfaction and Adherence [12 weeks]
Satisfaction and adherence will be measured using a self-report tool where participants indicate their satisfaction with program elements, and perceived adherence to the program over the study period. The minimum value is 4, the maximum value is 40, and a higher score means a better outcome.
Other Outcome Measures
- Demoralization (Exploratory) [12 weeks]
Demoralization will be captured through self report using the Demoralization Scale-II. The minimum score is 0, the maximum score is 32, and a higher score means a worse outcome.
- Edmonton Frail Scale (Exploratory) [12 weeks]
Frailty will be captured using the Edmonton Frail Scale. The minimum score is 0, the maximum score is 17, and a higher score means a worse outcome.
- Fried Frailty (Exploratory) [12 weeks]
Frailty will be captured using the Fried Frailty Score. The minimum score is 0, the maximum score is 5, and a higher score means a worse outcome.
- Healthcare Usage (Exploratory) [12 weeks]
Healthcare usage will be measured using a self-report tool where participants indicate healthcare service usage during the study period.
- Sleep (Exploratory) [12 weeks]
Impacts on sleep will be captured through self-report using the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8a. The minimum score is 8, the maximum score is 56, and a lower score means a worse outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adults ≥50 years of age
-
Identified diagnosis of one of nine chronic conditions (Heart Failure, PBC, Digestive Disease, Cirrhosis, Obesity, Cancer survivor, Post-transplant, Women who have experienced a cardiac event, Chronic Kidney Disease), or another general category for physical chronic conditions not captured by these nine
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HADS - Depression score ≤10
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English language proficiency to complete questionnaires and read the educational material
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Access to the Internet and a computer or smart device at home
Exclusion Criteria:
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Receiving compassionate care
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Inability to provide informed written consent
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Severe psychiatric disorders (HADS - Depression score >10, presence of uncontrolled schizophrenia, post-traumatic stress disorder (PTSD), and/or bipolar disorder unless approved to participate by their physician/psychologist; suicidality nearly every day)
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No access to the internet
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alberta | Edmonton | Alberta | Canada | T6G2X8 |
Sponsors and Collaborators
- University of Alberta
- Canadian Institutes of Health Research (CIHR)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00122568