Process evaluation for complex interventions in primary care: understanding trials using the normalization process model.
Carl R May, Frances S Mair, Christopher F Dowrick...
https://pubmed.ncbi.nlm.nih.gov/17650326/Actively Recruiting
Led by Göteborg University · Updated on 2025-03-12
220
Participants Needed
1
Research Sites
104 weeks
Total Duration
Researchers are evaluating a person-centered eHealth intervention designed to support community-dwelling frail older adults aged 75 and older. The study aims to promote health, self-management, and teamwork between older people and health and social care professionals. This project addresses the growing need for innovative healthcare solutions for older populations facing frailty and functional impairments, using a digital platform co-created with users to reduce hospitalizations and improve self-efficacy. The intervention lasts for six months and is provided alongside usual care. It includes a series of person-centered phone calls with healthcare professionals to co-create a personalized health plan. This plan identifies the older persons goals, resources, and support needs involving family, friends, and care professionals via a digital platform. If needed, a home visit will help install and introduce the digital platform on the participants device. Participants will be assessed at baseline and at 3, 6, and 12 months for outcomes such as self-efficacy, hospital care needs, quality of life, daily activities, falls, and cost-effectiveness. The study involves regular evaluations of the health plan between the older person, healthcare professionals, and their team through the digital platform. The trial includes a randomized controlled design with a control group receiving usual care and no intervention.
CONDITIONS
Integrating Health Promotion With and for Older People - eHealth
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Göteborg University
Lead Sponsor
The Swedish Research Council
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening may occur in person at an emergency department or primary care center, or by phone.
Duration - 6 months
Participants receive a person-centered eHealth intervention in addition to usual care for six months. This includes phone calls to co-create a health plan and ongoing communication with a health care professional and invited team members through a digital platform. If needed, one home visit is provided to install the digital platform and introduce its use.
Initial phone call, ongoing remote communication, and if needed, one home visit to set up the digital platform.
Duration - Up to 12 months
Participants are followed up to evaluate health outcomes, quality of life, and healthcare utilization up to 12 months after baseline.
Outcome assessments at baseline, 3, 6, and 12 months post-baseline.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Lead Sponsor
The Swedish Research Council
Collaborating Sponsor