12. Study protocol for the SOFIA project: Swallowing function, Oral health, and Food Intake in old Age: a descriptive study with a cluster randomized trial.

(a part of the SOFIA project)

Hägglund P., Olai L., Ståhlnacke K., Persenius M., Hägg M., Andersson M., Koistinen S., Carlsson E. BMC Geriatrics 2017, 17:78.  DOI 10.1186/s12877-017-0466-8

Abstract as published

Background Extensive studies have shown that older people are negatively impacted by impaired eating and nutrition. The abilities to eat, enjoy food, and participate in social activities associated with meals are important aspects of health-related quality of life (HRQoL) and recovery after illness. This project aims to (i) describe and analyze relationships between oral health and oral HRQoL, swallowing ability, eating ability, and nutritional risk among older individuals admitted to short-term care; (ii) compare the perceptions that older individuals and staff report on care quality related to oral hygiene and eating; and (iii) study the feasibility and effects of a training program for people with impaired swallowing (i.e., dysphagia). Methods/Design This project consists of two parts, which will be performed in five Swedish counties. It will include approximately 400 older individuals and 200 healthcare professionals. Part 1 is a cross-sectional, descriptive study of older people admitted to short-term care. Subjects will be assessed by trained professionals regarding oral health status, oral HRQoL, eating and nutritional risk, and swallowing ability. Swallowing ability will be measured with a teaspoon test and a swallowing capacity test (SCT). Furthermore, subjects and staff will complete a questionnaire regarding their perceptions of care quality. Part 2 is a cluster randomized intervention trial with controls. Older participants with dysphagia (i.e., SCT <10 ml/s, measured in part 1) will be recruited consecutively to either the intervention or control group, depending on where they were admitted for short-term care. At baseline, all subjects will be assessed for oral health status, oral HRQoL, eating and nutritional risk, swallowing ability, and swallowing related QoL. Then, the intervention group will receive 5 weeks of training with an oral screen for neuromuscular training focused on orofacial and pharyngeal muscles. After completing the intervention, and at six months post-intervention, all assessments will be repeated in both study groups. Discussion The results will make important contributions to rehabilitation knowledge, including approaches for improving swallowing function, oral health, and food intake and for improving the quality of oral care for older people.

Relevance to conditions

Dysphagia: Design of a study to show effectiveness of IQoro in improving swallowing in an elderly cohort.

Study type

Peer reviewed, Prospective, Cohort pre- and post- study, Multi-Centre, Randomized Control Trial (RCT).

Aim

Description of study design of a study taking place in 5 Swedish counties.

This project aims to:

(i) describe and analyse relationships between oral health and Health Related Quality of Life (HRQoL), swallowing ability, eating ability, and nutritional risk among older individuals admitted to short-term care;

(ii) compare the perceptions that older individuals and staff report on care quality related to oral hygiene and eating; and

(iii) study the feasibility and effects of a training program for people with impaired swallowing (i.e., dysphagia).

Patients

Approx 400 older individuals in short term residential care.
All are to be ≥ 65 years old and have been in the facility for >3 days.
Approx 200 healthcare professionals will be engaged.

Methods

This project consists of two parts and is to be conducted in 36 residential facilities across 5 counties.

Part 1 is a cross-sectional, descriptive study of older people admitted to short-term care. Subjects will be assessed by trained healthcare professionals,

Part 2 is a cluster randomized intervention trial with controls. Elderly participants with dysphagia will be recruited consecutively to either the intervention or control group, depending on where they were admitted for short-term care. The intervention group will receive IQoro neuromuscular training 3 x 10 seconds, three times per day for a duration of 5 weeks’. Those in the control groups will receive traditional and compensatory care.

At end of training, and at late follow up (6 months) post-training, all assessments will be repeated in both study groups. 

Outcome measurements

Part 1
Swallowing ability (using Timed Water Swallow Test – TWST) – lower normal value for swallowing rate ≥ 10 ml / sec
Health Related Quality of Life (HRQoL)
Oral health status
Oral Health Related Quality of Life (Oral HRQoL)
Eating and nutritional risk.
Subjects and staff will complete a questionnaire regarding their perceptions of care quality.

Part 2
Swallowing ability (using Timed Water Swallow Test – TWST) – lower normal value for swallowing rate ≥ 10 ml / sec
Oral health status
Oral HRQoL
Eating and nutritional risk
Swallowing related QoL

Discussion

The results will make important contributions to rehabilitation knowledge, including approaches for improving swallowing function, oral health, and food intake and for improving the quality of oral care for older people.