Clinical trial NCT06064110: Pictou County PEP: A 6-Month, Home-Based, Personal Empowerment Program for Adults With a Chronic Medical Condition Living in Pictou County
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Condition
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2023-10-03
Enrollment: 185
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mental Health as assessed by the Kessler Kessler Psychological Distress Scale (K10)
timeFrame: 6-12 months
Secondary outcomes:
measure: Incidence and severity of participant self-reported adverse events
timeFrame: 6-12 months
measure: The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
timeFrame: 6-12 months
measure: Personality as assessed by the Ten-Item Personality Inventory (TIPI)
timeFrame: 6-12 months
measure: Alcohol Habit assessed by questions from the National Health Institute Alcohol Consumption questionnaire.
timeFrame: 6-12 months
measure: Smoking habit assessed by the Global Adult Tobacco Survey 2020 (GATS).
timeFrame: 6-12 months
measure: Diet assessed by the Rapid Eating Assessment for Participants (REAP-S).
timeFrame: 6-12 months
measure: Comorbidity level assessed by the modified Charlson Comorbidity Index (CCI)
timeFrame: 6-12 months
measure: Availability of social support assessed by the MOS Social Support Survey
timeFrame: 6-12 months
measure: Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6-18 months
measure: Sedentary behaviour measured by the Sedentary Behaviour Questionnaire (SBQ) for Adults.
timeFrame: 6-12 months
measure: Anxiety severity assessed by the GAD-7.
timeFrame: 6-12 months
measure: Relationship satisfaction as assessed by the Dyadic Adjustment Scale (RDAS-14).
timeFrame: 6-12 months
measure: Center for Epidemiologic Studies Depression Scale (CES-D).
timeFrame: 6-12 months
measure: Satisfaction with Life Scale (SWLS).
timeFrame: 6-12 months
measure: Brief Illness Perception Questionnaire (BIPQ)
timeFrame: 6-12 months
measure: Perceived Stress Scale (PSS-10)
timeFrame: 6-12 months
measure: WHO-5 Well-Being Index
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: New Glasgow
country: Canada
facility: Aberdeen Hospital
state: Nova Scotia
Study officials:
References: