Back to resultsPictou County PEP: A Six-Month Home-Based Personal Empowerment Program for Adults With a Chronic Medical Condition Living in Pictou County
Primary Purpose
Chronic Condition
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pictou County Person Empowerment Program
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Condition
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention arm
Arm Description
Outcomes
Primary Outcome Measures
Mental Health as assessed by the Kessler Kessler Psychological Distress Scale (K10)
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 Outcome Measures
Incidence and severity of participant self-reported adverse events
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
A 40-item measure that assesses self-reported fatigue and its impact upon daily life, using a 5 point Likert-type scale with values ranging from 0-5, where higher scores represent worse outcomes.
Personality as assessed by the Ten-Item Personality Inventory (TIPI)
A 10 item questionnaire assessing the Big-Five personality dimensions (Extraversion, Agreeableness, Conscientiousness, Emotional Stability, Openness to Experiences). The scale has a score range of 1-14 for each dimension with higher scores indicating a higher level of that personality trait.
Alcohol Habit assessed by questions from the National Health Institute Alcohol Consumption questionnaire.
Questions assessing alcohol consumption using semantic differential scales that have a range of up to 11 response options. Response options range from never consuming alcohol to daily consumption, as well as consuming no alcohol each day to 25+ drinks a day on average, with higher scores being worse.
Smoking habit assessed by the Global Adult Tobacco Survey 2020 (GATS).
Questions assessing current and past smoking habit using semantic differential scales with possible answers ranging from daily smoking to not smoking at all. Lower scores indicate higher smoking habit/worse outcome.
Diet assessed by the Rapid Eating Assessment for Participants (REAP-S).
A 16 item questionnaire assessing diet quality. The scale has a score range of 13-39 with a higher score indicating a higher diet quality.
Comorbidity level assessed by the modified Charlson Comorbidity Index (CCI)
A 21 item questionnaire that uses a weighted index to assess the quantity and severity of comorbidities a patient has. Each comorbidity category has a related weight, ranging on a scale of 1-6, with higher scores representing worse outcomes.
Availability of social support assessed by the MOS Social Support Survey
A 19 item questionnaire that assesses emotional/informational support, positive social interaction, tangible support and affectionate support. Higher item scores reflect a higher level of social support.
Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
A 19 item questionnaire that assesses sleep quality and disturbances. The scale has a score range of 0-21 with a higher score indicating worse sleep quality.
Sedentary behaviour measured by the Sedentary Behaviour Questionnaire (SBQ) for Adults.
Two 9 item questionnaires (weekday and weekend) with each item scored to none to 6 hours or more. The total score is the sum of the amount of time and as it increases it indicates higher amount of sedentary behaviour.
Anxiety severity assessed by the GAD-7.
A 7 item questionnaire with scores ranging from 0-21 higher scores indicating more severe level of anxiety.
Relationship satisfaction as assessed by the Dyadic Adjustment Scale (RDAS-14).
A 14 item questionnaire that measure an individual's perceptions of their relationship with an intimate partner. The scale has a total score range of 1-151 with a higher score indicating better satisfaction.
Center for Epidemiologic Studies Depression Scale (CES-D).
A 20 item questionnaire with a possible range of scores from zero to 60, with the higher scores indicating the presence of more depressive symptomatology.
Satisfaction with Life Scale (SWLS).
A 5 item questionnaire that was designed to measure subjective well-being. Scores range from 5-35 with higher scores indicating higher satisfaction with life.
Brief Illness Perception Questionnaire (BIPQ)
A 9 item scale that measures an individual's beliefs, feelings, and cognitive representations of one's illness. This questionnaire uses linear numeric scales with response options ranging from 0-10. Total scores can range from 0-80, with higher scores representing worse illness perceptions.
Perceived Stress Scale (PSS-10)
A 10-item scale that measures a person's perceived feelings of stress during the last month. This questionnaire uses a Likert-type scale with response options scores ranging from 0-4. Scores on the PSS-10 can range from 0-40 with higher scores indicating higher perceived stress.
WHO-5 Well-Being Index
A short, 5-item, generic global rating scale measuring subjective well-being using a Likert-type scale. Scores range from 0-5, with higher scores indicating better well-being.
Full Information
NCT ID
NCT06064110
First Posted
September 26, 2023
Last Updated
October 20, 2023
Sponsor
Nova Scotia Health Authority
Collaborators
Dalhousie University
1. Study Identification
Unique Protocol Identification Number
NCT06064110
Brief Title
Pictou County PEP: A Six-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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2023 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Dalhousie University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Condition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Pictou County Person Empowerment Program
Other Intervention Name(s)
PictouCountyPEP
Intervention Description
The 6 month home-based program focuses on aerobic and strength training, meditation/relaxation techniques, social connection, and overall healthy lifestyle practices supported with daily email reminders. The aerobic (5 times/week) and strength (2 times/week) program will comprise of a single 30-minute session daily, the meditation/relaxation practice is 10 minutes daily, the intimacy and connection component consists of engaging in at least one form of intimacy practice prescribed, per day. Optional social connection components will be offered, such as pairing participants up with peers from the study, monthly Zoom videoconferences, and monthly in-person events in Pictou County to further promote healthy lifestyle habits.
Primary Outcome Measure Information:
Title
Mental Health as assessed by the Kessler Kessler Psychological Distress Scale (K10)
Description
A 10 item questionnaire that assesses psychological distress. The scale has a score range of 10-50, with higher scores indicating worse mental health.
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Incidence and severity of participant self-reported adverse events
Time Frame
6-12 months
Title
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Description
A 40-item measure that assesses self-reported fatigue and its impact upon daily life, using a 5 point Likert-type scale with values ranging from 0-5, where higher scores represent worse outcomes.
Time Frame
6-12 months
Title
Personality as assessed by the Ten-Item Personality Inventory (TIPI)
Description
A 10 item questionnaire assessing the Big-Five personality dimensions (Extraversion, Agreeableness, Conscientiousness, Emotional Stability, Openness to Experiences). The scale has a score range of 1-14 for each dimension with higher scores indicating a higher level of that personality trait.
Time Frame
6-12 months
Title
Alcohol Habit assessed by questions from the National Health Institute Alcohol Consumption questionnaire.
Description
Questions assessing alcohol consumption using semantic differential scales that have a range of up to 11 response options. Response options range from never consuming alcohol to daily consumption, as well as consuming no alcohol each day to 25+ drinks a day on average, with higher scores being worse.
Time Frame
6-12 months
Title
Smoking habit assessed by the Global Adult Tobacco Survey 2020 (GATS).
Description
Questions assessing current and past smoking habit using semantic differential scales with possible answers ranging from daily smoking to not smoking at all. Lower scores indicate higher smoking habit/worse outcome.
Time Frame
6-12 months
Title
Diet assessed by the Rapid Eating Assessment for Participants (REAP-S).
Description
A 16 item questionnaire assessing diet quality. The scale has a score range of 13-39 with a higher score indicating a higher diet quality.
Time Frame
6-12 months
Title
Comorbidity level assessed by the modified Charlson Comorbidity Index (CCI)
Description
A 21 item questionnaire that uses a weighted index to assess the quantity and severity of comorbidities a patient has. Each comorbidity category has a related weight, ranging on a scale of 1-6, with higher scores representing worse outcomes.
Time Frame
6-12 months
Title
Availability of social support assessed by the MOS Social Support Survey
Description
A 19 item questionnaire that assesses emotional/informational support, positive social interaction, tangible support and affectionate support. Higher item scores reflect a higher level of social support.
Time Frame
6-12 months
Title
Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Description
A 19 item questionnaire that assesses sleep quality and disturbances. The scale has a score range of 0-21 with a higher score indicating worse sleep quality.
Time Frame
6-18 months
Title
Sedentary behaviour measured by the Sedentary Behaviour Questionnaire (SBQ) for Adults.
Description
Two 9 item questionnaires (weekday and weekend) with each item scored to none to 6 hours or more. The total score is the sum of the amount of time and as it increases it indicates higher amount of sedentary behaviour.
Time Frame
6-12 months
Title
Anxiety severity assessed by the GAD-7.
Description
A 7 item questionnaire with scores ranging from 0-21 higher scores indicating more severe level of anxiety.
Time Frame
6-12 months
Title
Relationship satisfaction as assessed by the Dyadic Adjustment Scale (RDAS-14).
Description
A 14 item questionnaire that measure an individual's perceptions of their relationship with an intimate partner. The scale has a total score range of 1-151 with a higher score indicating better satisfaction.
Time Frame
6-12 months
Title
Center for Epidemiologic Studies Depression Scale (CES-D).
Description
A 20 item questionnaire with a possible range of scores from zero to 60, with the higher scores indicating the presence of more depressive symptomatology.
Time Frame
6-12 months
Title
Satisfaction with Life Scale (SWLS).
Description
A 5 item questionnaire that was designed to measure subjective well-being. Scores range from 5-35 with higher scores indicating higher satisfaction with life.
Time Frame
6-12 months
Title
Brief Illness Perception Questionnaire (BIPQ)
Description
A 9 item scale that measures an individual's beliefs, feelings, and cognitive representations of one's illness. This questionnaire uses linear numeric scales with response options ranging from 0-10. Total scores can range from 0-80, with higher scores representing worse illness perceptions.
Time Frame
6-12 months
Title
Perceived Stress Scale (PSS-10)
Description
A 10-item scale that measures a person's perceived feelings of stress during the last month. This questionnaire uses a Likert-type scale with response options scores ranging from 0-4. Scores on the PSS-10 can range from 0-40 with higher scores indicating higher perceived stress.
Time Frame
6-12 months
Title
WHO-5 Well-Being Index
Description
A short, 5-item, generic global rating scale measuring subjective well-being using a Likert-type scale. Scores range from 0-5, with higher scores indicating better well-being.
Time Frame
6-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Pictou County PEP: A Six-Month Home-Based Personal Empowerment Program for Adults With a Chronic Medical Condition Living in Pictou County
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