NCT06064110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 24, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

September 26, 2023

Last Update Submit

December 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    6-12 months

Secondary Outcomes (17)

  • Incidence and severity of participant self-reported adverse events

    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

  • Alcohol Habit assessed by questions from the National Health Institute Alcohol Consumption questionnaire.

    6-12 months

  • Smoking habit assessed by the Global Adult Tobacco Survey 2020 (GATS).

    6-12 months

  • +12 more secondary outcomes

Study Arms (1)

Intervention arm

EXPERIMENTAL
Behavioral: Pictou County Person Empowerment Program

Interventions

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.

Also known as: PictouCountyPEP
Intervention arm

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • +4 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Aberdeen Hospital

New Glasgow, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 3, 2023

Study Start

November 24, 2023

Primary Completion

May 14, 2025

Study Completion

October 28, 2025

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations