A Mixed Methods Randomized Controlled Trial Evaluating the Hans Kai Program

University of Manitoba

Status: Completed

Conditions: Loneliness; Social Isolation; Health-Related Behavior; Mental Health

Treatments: Behavioral: Hans Kai Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03949725

HS21887 (H2018:241)

Details and patient eligibility

About

The Hans Kai trial is a mixed methods randomized controlled trial evaluating the effectiveness of the peer-led health promotion Hans Kai program for Canadian adults with or without chronic health conditions. The Hans Kai trial also aims to identify the strengths and weaknesses of the Hans Kai program as well as the facilitators and barriers to its implementation from the perspectives of the program participants and facilitators. The intervention (Hans Kai program) consists of an 8-week health school that program participants attend to develop health knowledge and skills. Next, program participants form Hans Kai groups of 3 or more people, who meet on a monthly basis independently in a peer-led self-sustaining model. The trial will measure the impact of Hans Kai, compared to waitlist control, on program participants' mental health; social connections; health-related knowledge and empowerment (i.e., self-efficacy and self-determination); health-promoting behaviors (i.e., diet, alcohol consumption, tobacco use, physical activity, and sleep); and clinical measures of cardio-metabolic health.

Full description

The Hans Kai trial will follow a prospective mixed methods intervention design involving an RCT and an interpretative descriptive qualitative study. The mixed methods intervention design is a mixed methods approach to research in which the collection, analysis, and integration of both quantitative and qualitative data are embedded within an experimental quantitative research design. The objective of gathering qualitative data within an experiment, along with the quantitative data on the outcome measures, is to gain an understanding of the personal, contextual experiences of the study participants.

In this mixed methods intervention study design, quantitative data on the outcomes of interest will be collected along with qualitative data on the experiences of program participants and facilitators, and integrated within an intervention trial (i.e., RCT) to address the research objectives (see next section for details). The primary research design in this study will be a quantitative intervention trial or RCT that will follow a pragmatic randomized wait-list-control design with an 18-month follow-up. The RCT will involve the collection, analysis, and interpretation of quantitative data (self-reports and objective indicators) on primary, secondary, and tertiary outcomes that will be gathered to evaluate the effectiveness of the Hans Kai program in promoting the health and wellbeing of Canadian adults. To enrich the RCT results, the secondary qualitative strand of the study will be added during and after the intervention by embedding a combination of convergent and explanatory sequential designs into the RCT.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria. Participants may enter the trial if all the following apply.

• Age 18 years or above.
• Any gender.
• Willingness and ability to give informed consent for participation in the trial.
• Ability to speak and read English at a grade 6 level.
• Motivation to make a lifestyle change as indicated on the research study consent form.
• Stable health status that allows participation in the group context, including performing light exercise, to be determined by the participant and study Hans Kai staff.
• Ability and willingness to comply with all trial requirements, to be determined by the research team.

Exclusion Criteria. Participants may not enter the trial if any of the following apply.

• Age under 18 years.
• Cognitive impairment that prevents the person from providing informed consent or participating in the program.
• Existing relationship with the research team, such as supervisory relationship (e.g., student or employee) or familial relationship (e.g., child or spouse).
• Frailty that prevents the person from participating in group activities or exercise.
• Participation in another research trial in the past 12 weeks.
• Unstable health or serious illness, for example, dementia, terminal illness, or recent significant medical diagnosis.
• Inability to attend the scheduled Hans Kai Health School and assessment sessions.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 2 patient groups

Hans Kai program

Experimental group

Description:

The Hans Kai program is a peer-led, preventative, self-sustaining, community-based health promotion program for adults of all ages, genders, and socioeconomic circumstances who wish to maintain or improve their health. Hans Kai empowers individuals to take control of their own health and provides a unique opportunity for participants to have an active role in improving or maintaining their health and wellbeing.

Treatment:

Behavioral: Hans Kai Program

Wait list control

No Intervention group

Description:

Participants in the waitlist control group will remain as close to a 'typical' community member as possible as they will be able to receive any health programming normally available to them in Winnipeg, except the Hans Kai program. Standard of care is made available to all members of the control group as related to the healthcare rights of Canadians and Manitobans holding a Manitoba health card. NorWest staff will provide support to the community members without a Manitoba health card in obtaining one. The only deviation from standard care in the waitlist control group will be the pre- and post-intervention visits during which the control participants will fill out self-report questionnaires and undergo physical assessments.