NCT06064110CompletedNot Applicable
Pictou County PEP: A Phase 2 Trial of a Six-Month Home-Based Personal Empowerment Program to Improve the Mental and Physical Health of Adults With a Chronic Medical Condition Living in Pictou County
Nova Scotia Health Authority3 sites in 1 country185 target enrollmentStarted: November 24, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nova Scotia Health Authority
- Enrollment
- 185
- Locations
- 3
- Primary Endpoint
- Mental Health as assessed by the Kessler Kessler Psychological Distress Scale (K10)
Study Overview
Brief Summary
The Pictou County Personal Empowerment Program is a comprehensive health promotion program aiming to improve the quality of life as well as both physical and mental health in Adults living with chronic medical conditions. The program includes daily email communications over 6 months that encourage a range of self-management and health promoting activities, including strength and aerobic exercise, yoga, stress reduction techniques, dietary improvements, relationship/intimacy education and more.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >18;
- •Diagnosed with one or more chronic medical conditions, as per the participant's report, including but not restricted to the following (complete list in protocol appendix):
- •Heart disease / cardiovascular disease / stroke
- •High blood pressure
- •Diabetes including a diagnosis of pre-diabetes
- •Chronic respiratory disease
- •Chronic neurologic disease
- •Chronic kidney disease
- •Chronic liver disease
- •Immunodeficiency
- •Overweight or Obese (BMI >25)
- •Psychiatric or mental health issue - e.g., depression and anxiety
- •Substance-related and addictive disorders (e.g alcohol, smoking, etc.);
- •Resident of Pictou County, Nova Scotia;
- •Existing (or willingness to create) email account and willingness to access email daily;
- •Ability to follow website links to watch YouTube videos;
- •Ability to understand and speak English;
- •Ability to participate in low to moderate levels of physical activity and strength training;
- •Ability and willingness to fill out an online survey at baseline, and 6, 12 months, and fill in a weekly compliance survey for the six months of the program.
Exclusion Criteria
- •Diagnosed with cancer in the last 5 years and/or received treatment for cancer in the last 5 years;
- •Myocardial infarction or stroke within the last year AND without written approval from their Family Physician, Cardiologist, or Study Physician that they are safe to exercise;
- •Unable to access the internet daily during the intervention;
- •Lack of access to a computer or smartphone to receive emails required for study intervention.
Arms & Interventions
Intervention arm
Experimental
Intervention: Pictou County Person Empowerment Program (Behavioral)
Outcomes
Primary Outcomes
Mental Health as assessed by the Kessler Kessler Psychological Distress Scale (K10)
Time Frame: 6-12 months
A 10 item questionnaire that assesses psychological distress. The scale has a score range of 10-50, with higher scores indicating worse mental health.
Secondary Outcomes
- Availability of social support assessed by the MOS Social Support Survey(6-12 months)
- Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)(6-18 months)
- Anxiety severity assessed by the GAD-7.(6-12 months)
- Incidence and severity of participant self-reported adverse events(6-12 months)
- Alcohol Habit assessed by questions from the National Health Institute Alcohol Consumption questionnaire.(6-12 months)
- Comorbidity level assessed by the modified Charlson Comorbidity Index (CCI)(6-12 months)
- Relationship satisfaction as assessed by the Dyadic Adjustment Scale (RDAS-14).(6-12 months)
- Brief Illness Perception Questionnaire (BIPQ)(6-12 months)
- WHO-5 Well-Being Index(6-12 months)
- The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)(6-12 months)
- Personality as assessed by the Ten-Item Personality Inventory (TIPI)(6-12 months)
- Smoking habit assessed by the Global Adult Tobacco Survey 2020 (GATS).(6-12 months)
- Center for Epidemiologic Studies Depression Scale (CES-D).(6-12 months)
- Diet assessed by the Rapid Eating Assessment for Participants (REAP-S).(6-12 months)
- Sedentary behaviour measured by the Sedentary Behaviour Questionnaire (SBQ) for Adults.(6-12 months)
- Satisfaction with Life Scale (SWLS).(6-12 months)
- Perceived Stress Scale (PSS-10)(6-12 months)
Investigators
Gabriela Ilie
Associate Professor
Dalhousie University
Study Sites (3)
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