Abstract
BackgroundThe present randomized controlled trial, which is crossed with the “PREVenting the impairment of primary Osteoarthritis by high impact long-term Physical exercise regimen” Main Medical Trial (PrevOP-MMT), aims to evaluate a psychological adherence program (PrevOP-PAP), and is designed to support persons with knee osteoarthritis (OAK) in the uptake and maintenance of regular physical activity to reduce OAK symptoms. The PrevOP-PAP is based on the Health Action Process Approach (HAPA), a social-cognitive theory predicting health behavior change in individuals, extended here by social network characteristics and social exchange processes. It is expected that participants with OAK receiving the PrevOP-PAP will maintain higher levels of regular physical activity throughout a 24-month period and consequently report lower levels of OAK symptoms than participants of an active control condition.MethodsA total of N = 240 participants with medically verified moderate OAK will be randomly assigned to an intervention condition (PrevOP-PAP-I; 50%) or an active control condition (PrevOP-PAP-CTRL). The PrevOP-PAP-I includes a motivational intervention, repeated self-regulation interventions, and a network creation intervention delivered over 12 months. Modes of intervention delivery include a paper-pencil motivation leaflet with a quiz, a computer-assisted face-to-face intervention, four computer assisted phone-based interventions, and activity calendars. The PrevOP-PAP-CTRL includes the motivational intervention only. Primary outcome will be OAK symptoms. Secondary outcomes include objectively and subjectively measured physical activity and indicators of quality of life. Other outcomes are HAPA-derived self-regulatory indicators as well as proposed social network and social exchange mechanisms of health behavior change. Assessments take place at baseline, 6 months, 12 months, 18 months, and 24 months following baseline.DiscussionBased on the extended HAPA, this study seeks to reveal the self-regulatory and social mechanisms of the uptake and maintenance of physical activity and their relation to disease symptoms in persons with OAK. The design and evaluation of this program are intended to become a yardstick for future development and implementation of digitalized psychological adherence programs in this population.Trial registrationGerman Clinical Trials Register; also available at http://apps.who.int/trialsearch/; registration number: DRKS00009677; date of registration: 26 January 2016.
Highlights
The session starts with a reiteration of the project goals and the goals of the present intervention session
Participants are reminded that physical activity (PA) helps with OsteoArthritis of the Knee (OAK) symptoms, but that regular PA may not be an easy task which is why self-regulation strategies are practiced in this intervention session (BCT 4.1; [13])
Goal/plan review Following this general assessment of the PA goals for the past two weeks, each goal set during the past intervention session is reviewed
Summary
Design The PrevOP-PAP trial shares participants, inclusion-, and exclusion criteria with the PrevOP-MMT (crossed design). Informed consent and inclusion into the study takes place at the beginning of baseline assessments (T0) and is done by the PrevOP-MMT’s medical personnel, when participants receive extensive information on the study procedure (PrevOP-MMT and PrevOP-PAP parts; oral and written) including randomization procedures, provide written informed consent, and begin their first period of assessments. I.e., between T0 and T1, participants will be randomized to one of 6 study arms (3 PrevOP-MMT * 2 PrevOP-PAP conditions, see Fig. 2), using computer-generated random numbers, stratified by gender. Masking Regarding study staff conducting the PrevOP-PAP intervention sessions, allocation of participants to intervention or control conditions cannot be masked. PrevOP-PAP intervention and -control conditions The PrevOP-PAP is designed to improve motivation to be physically active and enhance exercise adherence by conveying volitional self-regulation strategies to improve maintenance and prevent relapse to sedentary behavior in persons with OAK. Intervention content-fields are enriched by photos of physically active adults (mid-age to old age), sports utensils, framed summary messages, and depictions meant to illustrate the topic of the respective intervention section
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