RNProtocolNursing open2021

A study protocol for a feasibility trial of telephone-delivered Adherence Therapy for adults with type 2 diabetes.

Fatimah Alenazi, Monica Peddle, Daniel Bressington and 2 others

PMID 33471963

WHAT IT FOUND

This protocol plans a feasibility trial of telephone-delivered adherence therapy for adults with type 2 diabetes in Saudi Arabia.

It aims to test if the therapy is acceptable and if a full trial is possible. No patient results or efficacy data are reported.

Key findings

01The study is a protocol for a two-part process: a cultural adaptation study followed by a randomized controlled feasibility trial.

02The intervention involves eight sessions of telephone-delivered adherence therapy, lasting approximately 30 minutes each, over four weeks.

03The primary outcome is the feasibility of recruiting patients, not the effectiveness of the therapy on health outcomes.

STILL TO COME

How it was doneWhat they foundWhat it means for RNs

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What it does not show

This is a protocol for a feasibility trial, so it contains no actual results or data on patient outcomes. The study is not designed or powered to determine if the therapy works (efficacy). The trial is open-label, meaning both patients and researchers know who is receiving the intervention, which can introduce bias. The researcher delivering the therapy also collects the outcome data, which may introduce potential for bias or coercion.

Declared interests

One author (RG) developed the adherence therapy intervention but declares no financial benefit from the therapy or the trial. The study is funded by the Ministry of Higher Education.

The easy way to misread this

Do not interpret this paper as evidence that telephone-delivered adherence therapy improves diabetes outcomes. It is a protocol for a feasibility study that has not yet collected or reported any patient data.

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