10 Prescriptions an Hour. Group Treatment and Physical Activity Referral in a Primary Health Care Setting (10PAR)
Randomized Controlled Trial of Group Treatment With Physical Activity Referral in a Primary Health Care Setting
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
A sedentary lifestyle and low levels of physical activity in populations are major health problems today and contribute substantially to poor health and diseases such as type 2 diabetes and hypertension. An increased and systematic effort to increase physical activity in the Swedish population in general, and in patients with type 2 diabetes/hypertension in particular, is important. Written prescriptions of physical activity with follow-up (i.e., PAR), is a cost-efficient way to increase physical activity in individuals.
The aim of this trial is to study whether physical activity is increased by a group method involving PARs in patients with hypertension and/or type 2 diabetes compared with a control group that receives usual care in the same primary care setting. Follow-up will be performed at 6 and 12 months.
This trial is being conducted to determine whether it is possible to offer PARs to more patients in a way that requires less effort and resources. The intervention in this study requires 10 minutes of a health care worker's time per patient during a 6-month period. Each patient requires 100 minutes with an instructor who oversees the group intervention.
Group treatment is given 3 weeks after baseline and at 6 months. Follow-up at 12 months involves data collection, but no intervention.
An empowerment process, with the 5-A-model as framework, will be used in the clinical intervention.
All participants will be required to fill in questionnaires and wear an ActiGraph GTM1/GTM3 for 7 days at baseline and at 6 and 12 months.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Malmö, Svezia
- Center for Primary Health Care Research, Lund University/Region Skane
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Clinical diagnosis of hypertension or type 2 diabetes since 10-09-2009 at St Hans Primary Health Care Center, Lund, Sweden
Exclusion criteria:
- Dementia
- Psychosis
- Drug abuse
- Mental retardation
- Inability to walk without assistance
- Inability to speak Swedish
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Solita cura
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Sperimentale: Group treatment and PAR
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Group treatment (8-12 patients per group) involving an empowerment-based process and the 5-A model and including PAR.
Two group sessions, 6 months apart.
The estimated total time for both group sessions together is 100 minutes.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Physical activity level
Lasso di tempo: Up to 1 year
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Physical activity level is measured with an Actigraph GTM1/3.
Overall physical activity, and total accumulated time and bouts of time in different categories of physical activity, will be determined according to count thresholds.
Additonally subjective measurements of physical acidity are made using a questionnaire were questions about self-reported physical activity are reported (the International Physical Activity Questionnaire; IPAQ).
Subjectively measured physical activity will be expressed as MET-minutes/week.
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Up to 1 year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Quality of life, measured using the EQ-5D questionnaire
Lasso di tempo: 1 year
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EQ-5D, a validated instrument that classifies health according to five items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each of which has three alternatives ("no problem", "moderate problem" and "severe problem").
Combining the answers gives an index with a score of between 0.59 and 1.0.
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1 year
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Dnr 2011/95
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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