Chronic ConditionNCT06064110
Pictou County PEP: A 6-Month, Home-Based, Personal Empowerment Program for Adults With a Chronic Medical Condition Living in Pictou County
A study testing Pictou County Person Empowerment Program in people with Chronic Condition, run by Nova Scotia Health Authority at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Condition
- What is being tested?
- Pictou County Person Empowerment Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 2 sitesCanada
- Study dates
- 24 Nov 2023to 28 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
QEII Health Sciences Centre
Halifax, Nova Scotia
Aberdeen Hospital
New Glasgow, Nova Scotia
About this study
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
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.
- Conditions
- Chronic Condition
- Being tested
- Pictou County Person Empowerment Program
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pictou County Person Empowerment ProgramBehavioural
Also called PictouCountyPEP
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Not described Receives: Behavioral: Pictou County Person Empowerment Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-12 months
Secondary outcomes (17)
Incidence and severity of participant self-reported adverse events
Measured: 6-12 months
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.
Measured: 6-12 months
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.
Measured: 6-12 months
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.
Measured: 6-12 months
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.
Measured: 6-12 months
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.
Measured: 6-12 months
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.
Measured: 6-12 months
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.
Measured: 6-12 months
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.
Measured: 6-18 months
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.
Measured: 6-12 months
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.
Measured: 6-12 months
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.
Measured: 6-12 months
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.
Measured: 6-12 months
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.
Measured: 6-12 months
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.
Measured: 6-12 months
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.
Measured: 6-12 months
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.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start24 Nov 2023
- Primary completion14 May 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConditionStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Principal investigator, Gabriela Ilie, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064110
- Sponsor's protocol ID
- Pictou-County-PEP
- Status last verified
- Dec 2025
- First submitted
- 26 Sep 2023
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06064110
- Acronym / sponsor ID
- Pictou-County-PEP
- Conditions
- Chronic Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Pictou County Person Empowerment Program |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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):
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pictou County Person Empowerment ProgramAlso: PictouCountyPEPThe 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. | Behavioural | Intervention arm |
Primary outcome
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.
17 secondary outcomes
Incidence and severity of participant self-reported adverse events
Time frame: 6-12 months
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time frame: 6-12 months
Personality as assessed by the Ten-Item Personality Inventory (TIPI)
Time frame: 6-12 months
Alcohol Habit assessed by questions from the National Health Institute Alcohol Consumption questionnaire.
Time frame: 6-12 months
Smoking habit assessed by the Global Adult Tobacco Survey 2020 (GATS).
Time frame: 6-12 months
Diet assessed by the Rapid Eating Assessment for Participants (REAP-S).
Time frame: 6-12 months
Comorbidity level assessed by the modified Charlson Comorbidity Index (CCI)
Time frame: 6-12 months
Availability of social support assessed by the MOS Social Support Survey
Time frame: 6-12 months
Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6-18 months
Sedentary behaviour measured by the Sedentary Behaviour Questionnaire (SBQ) for Adults.
Time frame: 6-12 months
Anxiety severity assessed by the GAD-7.
Time frame: 6-12 months
Relationship satisfaction as assessed by the Dyadic Adjustment Scale (RDAS-14).
Time frame: 6-12 months
Center for Epidemiologic Studies Depression Scale (CES-D).
Time frame: 6-12 months
Satisfaction with Life Scale (SWLS).
Time frame: 6-12 months
Brief Illness Perception Questionnaire (BIPQ)
Time frame: 6-12 months
Perceived Stress Scale (PSS-10)
Time frame: 6-12 months
WHO-5 Well-Being Index
Time frame: 6-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pictou County Person Empowerment Program in people with Chronic Condition, run by Nova Scotia Health Authority at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health as assessed by the Kessler Kessler Psychological Distress Scale (K10) (time frame: 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.